CLINICAL TRIALS PROFILE FOR OCTREOSCAN

All Clinical Trials for Octreoscan

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001228 ↗	Interferon and Octreotide to Treat Zollinger-Ellison Syndrome and Advanced Non-B Islet Cell Cancer	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	1988-10-25	This study will examine the safety and effectiveness of interferon-a and octreotide for the treatment of Zollinger-Ellison syndrome (gastrinoma) and advanced non-B islet cell cancer. Gastrinoma is a tumor produced by the pancreas that secretes the hormone gastrin, which in turn stimulates production of gastric juices that cause ulcers. Some of these tumors are malignant. Gastrinomas that have spread and cannot be surgically removed require drug treatment (chemotherapy). Current drug regimens, however, provide only temporary benefit and, in some cases, produce life-threatening side effects. In studies of patients with tumors similar to gastrinoma, the drugs octreotide and interferon-a, alone or in combination, showed some effect in stopping tumor growth and were better tolerated than chemotherapy. At least one-third of patients responded to treatment with either drug for at least 6 months; the two drugs given together may produce a better response than either one alone. Patients currently enrolled in an NIH study of Zollinger-Ellison syndrome whose gastrinoma has spread from the original site and cannot be surgically removed may be eligible for this study. Participants will be admitted to the NIH Clinical Center for blood and urine tests, electrocardiogram (EKG), chest X-ray and imaging studies (CT, ultrasound, MRI, octreoscan, and bone scan) before beginning treatment to evaluate the size and extent of tumors. Patients will then start interferon-a or octreotide, or both, given as injections under the skin. Treatment will continue for at least 6 months, unless side effects require stopping the drugs early. Patients whose tumors shrink or remain stable may continue treatment indefinitely. Those who do not respond to treatment will be taken off the study and offered standard chemotherapy. Patients will be admitted to the hospital for the first day or two of therapy to be monitored for side effects and to learn how to self-inject the drugs to continue therapy at home. Both drugs are given [Note: how often? once a day, twice a day, weekly?] (Octreotide is also available in long-acting form, and patients who prefer may be given this drug once a month by the doctor.) During the treatment period, patients will be seen by their personal physician every 2 weeks for the first month and once a month thereafter for a medical evaluation and check of adverse side effects of treatment. In addition, they will be admitted to the NIH Clinical Center once every 3 months for a medical evaluation and imaging studies, including CT, MRI, ultrasound, bone scan, and octreoscan, to assess the effect of treatment on tumor size.
NCT00001849 ↗	New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1999-05-20	Cushing Syndrome is an endocrine disorder causing an over production of the hormone cortisol. Cortisol is produced in the adrenal gland as a response to the production of corticotropin (ACTH) in the pituitary gland. Between 10% and 20% of patients with hypercortisolism (Cushing Syndrome) have ectopic production of the hormone ACTH. Meaning, the hormone is not being released from the normal site, the pituitary gland. In many cases the ectopic ACTH is being produced by a tumor of the lung, thymus, or pancreas. However, in approximately 50% of these patients the source of the ACTH cannot be found even with the use of extensive imaging studies such as computed tomography (CT) scans, magnetic resonance imaging (MRI), and nuclear scans (111-indium pentetreotide). The ability of these tests to locate the source of the hormone production is dependent on the changes of anatomy and / or the dose and adequate uptake of the radioactive agent. The inability to detect the source of ectopic ACTH production often results in unnecessary pituitary surgery or irradiation. Unlike the previously described tests, positron emission tomography (PET scan) has the ability to detect pathologic tissue based on physiologic and biochemical processes within the abnormal tissue. This study will test whether fluorine-18-fluorodeoxyglucose (FDG), fluorine-18-dihydroxyphenylalanine (F-DOPA) or use of a higher dose of 111-indium pentetreotide can be used to successfully localize the source of ectopic ACTH production.
NCT00084461 ↗	Romidepsin in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors	Terminated	National Cancer Institute (NCI)	Phase 2	2004-03-01	Phase II trial to study the effectiveness of romidepsin in treating patients who have locally advanced or metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as romidepsin, work in different ways to stop tumor cells from dividing so they stop growing or die.
NCT00495846 ↗	GH, IGF-I and Somatostatin Analogues in Hepatocellular Carcinoma	Completed	Azienda Ospedaliera "D Cotugno" Hospital of Infectious Diseases	Phase 2/Phase 3	2007-04-01	The hepatocellular carcinoma (HCC) represents more than 5% of all human malignancies, with more than 500,000 deaths per year (1). In Campania region, mortality for HCC is 2 times higher than in the rest of Italy because of a higher locally prevalence of hepatitis-C virus infection. Development of HCC in liver cirrhosis is associated with increased DNA synthesis and regeneration of hepatocytes (2). Hepatocyte growth factor, the transforming growth factor-α, the fibroblast growth factor are well studied (3,4) while the insulin-like growth factor system (IGF-I, IGF-II and their binding proteins) has been less investigated. IGF-I and IGF-II modulate growth, metabolism and cell differentiation and have specific receptors in the liver (5). IGF-I levels in the upper normal range have been associated with an increased risk to develop prostate cancer (6), breast cancer (7) and colon cancer (8). Some data report increased expression of IGF-II in HCC (9,10) and others suggest a role of increased IGF-I bioavailability in HCC (11). We reported increased IGF-I/IGFBP-3 ratio in patients with HCC compared with those with cirrhosis with a similar liver function, so suggesting increased IGF-I bioavailability in HCC (12). There is no currently medical treatment for patients with advanced HCC which has a very poor prognosis (survival <6 months). Because of limited liver function, classical chemotherapy cannot be applied (13). In patients with HCC without cirrhosis, surgery is possible only in 5% while in those with cirrhosis first-line treatment is still questioned as survival is <50% three years after operation. Patients suitable for local resection of HCC are only those with Child-Pugh's "hyper A" liver function class, who are a minority (14-16). Percutaneous resection treatments may treat approximately 70%-90% of tumors with maximal diameters of <3 cm (15,17-19). Somatostatin analogues are indicated in patients with neuroendocrine tumors expressing somatostatin receptors type 2 and 5 and has excellent safety profile. In advanced HCC, some studies demonstrated beneficial effects (20,21) while some others did not (22,23). Only a few data are available on somatostatin receptor expression in HCC (24,25). Somatostatin analogues have also a clear-cut inhibitory effect on circulating IGF-I levels with a potential additional effect in delaying HCC progression.
NCT00495846 ↗	GH, IGF-I and Somatostatin Analogues in Hepatocellular Carcinoma	Completed	Ospedali dei Colli	Phase 2/Phase 3	2007-04-01	The hepatocellular carcinoma (HCC) represents more than 5% of all human malignancies, with more than 500,000 deaths per year (1). In Campania region, mortality for HCC is 2 times higher than in the rest of Italy because of a higher locally prevalence of hepatitis-C virus infection. Development of HCC in liver cirrhosis is associated with increased DNA synthesis and regeneration of hepatocytes (2). Hepatocyte growth factor, the transforming growth factor-α, the fibroblast growth factor are well studied (3,4) while the insulin-like growth factor system (IGF-I, IGF-II and their binding proteins) has been less investigated. IGF-I and IGF-II modulate growth, metabolism and cell differentiation and have specific receptors in the liver (5). IGF-I levels in the upper normal range have been associated with an increased risk to develop prostate cancer (6), breast cancer (7) and colon cancer (8). Some data report increased expression of IGF-II in HCC (9,10) and others suggest a role of increased IGF-I bioavailability in HCC (11). We reported increased IGF-I/IGFBP-3 ratio in patients with HCC compared with those with cirrhosis with a similar liver function, so suggesting increased IGF-I bioavailability in HCC (12). There is no currently medical treatment for patients with advanced HCC which has a very poor prognosis (survival <6 months). Because of limited liver function, classical chemotherapy cannot be applied (13). In patients with HCC without cirrhosis, surgery is possible only in 5% while in those with cirrhosis first-line treatment is still questioned as survival is <50% three years after operation. Patients suitable for local resection of HCC are only those with Child-Pugh's "hyper A" liver function class, who are a minority (14-16). Percutaneous resection treatments may treat approximately 70%-90% of tumors with maximal diameters of <3 cm (15,17-19). Somatostatin analogues are indicated in patients with neuroendocrine tumors expressing somatostatin receptors type 2 and 5 and has excellent safety profile. In advanced HCC, some studies demonstrated beneficial effects (20,21) while some others did not (22,23). Only a few data are available on somatostatin receptor expression in HCC (24,25). Somatostatin analogues have also a clear-cut inhibitory effect on circulating IGF-I levels with a potential additional effect in delaying HCC progression.
NCT00495846 ↗	GH, IGF-I and Somatostatin Analogues in Hepatocellular Carcinoma	Completed	Federico II University	Phase 2/Phase 3	2007-04-01	The hepatocellular carcinoma (HCC) represents more than 5% of all human malignancies, with more than 500,000 deaths per year (1). In Campania region, mortality for HCC is 2 times higher than in the rest of Italy because of a higher locally prevalence of hepatitis-C virus infection. Development of HCC in liver cirrhosis is associated with increased DNA synthesis and regeneration of hepatocytes (2). Hepatocyte growth factor, the transforming growth factor-α, the fibroblast growth factor are well studied (3,4) while the insulin-like growth factor system (IGF-I, IGF-II and their binding proteins) has been less investigated. IGF-I and IGF-II modulate growth, metabolism and cell differentiation and have specific receptors in the liver (5). IGF-I levels in the upper normal range have been associated with an increased risk to develop prostate cancer (6), breast cancer (7) and colon cancer (8). Some data report increased expression of IGF-II in HCC (9,10) and others suggest a role of increased IGF-I bioavailability in HCC (11). We reported increased IGF-I/IGFBP-3 ratio in patients with HCC compared with those with cirrhosis with a similar liver function, so suggesting increased IGF-I bioavailability in HCC (12). There is no currently medical treatment for patients with advanced HCC which has a very poor prognosis (survival <6 months). Because of limited liver function, classical chemotherapy cannot be applied (13). In patients with HCC without cirrhosis, surgery is possible only in 5% while in those with cirrhosis first-line treatment is still questioned as survival is <50% three years after operation. Patients suitable for local resection of HCC are only those with Child-Pugh's "hyper A" liver function class, who are a minority (14-16). Percutaneous resection treatments may treat approximately 70%-90% of tumors with maximal diameters of <3 cm (15,17-19). Somatostatin analogues are indicated in patients with neuroendocrine tumors expressing somatostatin receptors type 2 and 5 and has excellent safety profile. In advanced HCC, some studies demonstrated beneficial effects (20,21) while some others did not (22,23). Only a few data are available on somatostatin receptor expression in HCC (24,25). Somatostatin analogues have also a clear-cut inhibitory effect on circulating IGF-I levels with a potential additional effect in delaying HCC progression.
NCT00514046 ↗	Vandetanib to Treat Children and Adolescents With Medullary Thyroid Cancer	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2007-07-20	Background: - Medullary thyroid carcinoma (MTC) is common in people with a genetic disorder called multiple endocrine neoplasia (MEN). - Vandetanib is an experimental drug that blocks a defective protein receptor (rearranged during transfection (RET) receptor) found on the surface of cancer cells in people with MEN. It is thought that this protein is a primary cause of MTC in people with MEN. Objectives: - To study the activity of Vandetanib in children and adolescents with MEN-related MTC by measuring the change in tumor size, in blood levels of proteins produced the tumor (calcitonin and carcinoembryonic antigen (CEA) and in tumor-related diarrhea. - To determine the safety and tolerability of Vandetanib in children and adolescents. - To study how the body handles Vandetanib in children and adolescents. - To determine the effect of Vandetanib on the survival of children and adolescents with MTC. Eligibility: -Children and adolescents 5 to 18 years of age with MTC whose tumor cannot be surgically removed or has grown back after treatment or has metastasized (spread beyond the thyroid gland). Design: - Patients take Vandetanib once a day in 28-day cycles. The first patients enrolled in the study are started on a low dose of Vandetanib to determine tolerability. - Patients have periodic blood tests, electrocardiograms, and blood pressure measurements to look for side effects of Vandetanib. - Blood tests and imaging scans (magnetic resonance imaging (MRI), computed tomography (CT), bone and octreoscan) are done every 8 weeks for the first 32 weeks of treatment and then every 16 weeks for the duration of the treatment period. - Patients who have tumor-related diarrhea keep a daily record of the number and consistency of bowel movements.

Clinical Trial Conditions for Octreoscan

Condition Name

Condition Name for Octreoscan
Intervention	Trials
Neuroendocrine Tumors	7
Cushing Syndrome	2
Medulloblastoma	1
Pulmonary Carcinoid Tumor	1

Condition MeSH

Condition MeSH for Octreoscan
Intervention	Trials
Neuroendocrine Tumors	12
Carcinoid Tumor	9
Neoplasms	5
Syndrome	3

Clinical Trial Locations for Octreoscan

Trials by Country

Trials by Country for Octreoscan
Location	Trials
United States	31
Canada	6
France	3
Italy	2
Netherlands	1

Trials by US State

Trials by US State for Octreoscan
Location	Trials
Maryland	5
Texas	3
Massachusetts	2
New York	2
Pennsylvania	2

Clinical Trial Progress for Octreoscan

Clinical Trial Phase

Clinical Trial Phase for Octreoscan
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Octreoscan
Clinical Trial Phase	Trials
Completed	11
Terminated	4
Recruiting	3

Clinical Trial Sponsors for Octreoscan

Sponsor Name

Sponsor Name for Octreoscan
Sponsor	Trials
Mallinckrodt	2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2

Sponsor Type

Sponsor Type for Octreoscan
Sponsor	Trials
Other	21
Industry	7
NIH	6

Octreoscan and Related Therapies: Clinical Trials, Market Analysis, and Projections

Introduction

Octreoscan, though not the primary focus of recent clinical trials, is closely related to the broader category of somatostatin analogs and radioligand therapies, particularly those involving octreotide and Lu 177-dotatate (Lutathera). This article will delve into the latest clinical trials, market analysis, and projections for these related therapies, which are pivotal in the treatment of neuroendocrine tumors (NETs) and other conditions.

Clinical Trials Update: Lutathera and Octreotide

NETTER-2 Trial

The NETTER-2 trial has been a significant milestone in the treatment of advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This phase III trial demonstrated that the combination of Lutathera (Lu 177-dotatate) and long-acting release (LAR) octreotide significantly reduced the risk of disease progression or death by 72% compared to high-dose octreotide LAR alone[3][4].

• Progression-Free Survival (PFS): Patients receiving Lutathera plus octreotide LAR had a median PFS of 22.8 months, whereas those receiving high-dose octreotide LAR alone had a median PFS of 8.5 months[3][4].
• Objective Response Rate (ORR): The combination therapy resulted in an ORR of 43%, significantly higher than the 9.3% observed with octreotide alone[4].

These findings have substantial implications for the treatment of newly diagnosed advanced GEP-NETs, offering a new and effective first-line therapy option.

Market Analysis: Somatostatin Analogs

Global Market Overview

The global somatostatin analogs market, which includes octreotide, lanreotide, and pasireotide, is experiencing significant growth. Here are some key points:

• Market Size and Growth: The global octreotide market was valued at approximately USD 2.1 billion in 2023 and is expected to reach USD 3.4 billion by 2033, growing at a CAGR of around 6% during the forecast period[5].
• Regional Growth: The Asia-Pacific region is anticipated to be the fastest-growing market, driven by the rising prevalence of hormonal disorders and NETs, expansion of healthcare infrastructure, and increasing awareness of early diagnosis and effective management[5].

Key Players and Developments

Several pharmaceutical companies are actively involved in the development and marketing of somatostatin analogs:

• Novartis AG: Novartis is a major player, particularly with its radioligand therapy Lutathera. The company is focusing on expanding Lutathera's use as a first-line treatment for GEP-NETs, which could open up a $1 billion market opportunity[3].
• Other Players: Companies like Sun Pharma, WOCKHARDT, Ipsen Pharma, and others are also developing new formulations and therapies in the pre-clinical and clinical stages[2].

Market Projections

Growth Drivers

Several factors are driving the growth of the somatostatin analogs market:

• Increasing Prevalence of NETs: The rising incidence of neuroendocrine tumors, particularly in regions like Asia-Pacific, is a significant driver[2][5].
• Advancements in Drug Delivery: Technological advancements in drug delivery systems, such as long-acting and extended-release formulations, are improving patient convenience and adherence to treatment[5].
• Expanding Healthcare Infrastructure: Improving access to healthcare services in emerging markets is fueling the demand for effective treatments[5].

Market Segmentation

The market is segmented based on type, application, and region:

• Type: Octreotide, lanreotide, and pasireotide are the primary types of somatostatin analogs[2].
• Application: Key applications include acromegaly, neuroendocrine tumors (NETs), and other conditions like carcinoid syndrome[5].
• Region: North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa are the main regional markets[2][5].

Future Outlook

Emerging Trends

The market is expected to continue its growth trajectory driven by several emerging trends:

• Novel Formulations: The development and approval of new octreotide formulations, such as long-acting and extended-release products, will offer more effective and convenient treatment options[5].
• Radioligand Therapies: The success of radioligand therapies like Lutathera is expected to further expand the market, especially as these therapies move into earlier lines of treatment[3][4].

Regional Focus

The Asia-Pacific region, particularly countries like China and India, will be a focal point for growth due to their large and growing populations, improving healthcare infrastructure, and increasing focus on patient outcomes[5].

Key Takeaways

• Clinical Trials: The NETTER-2 trial has shown significant benefits of combining Lutathera with octreotide for advanced GEP-NETs.
• Market Growth: The global somatostatin analogs market is expected to grow at a CAGR of around 6%, driven by increasing prevalence of NETs and advancements in drug delivery.
• Regional Expansion: The Asia-Pacific region is anticipated to be the fastest-growing market.
• Novel Therapies: Radioligand therapies like Lutathera are expanding treatment options and improving patient outcomes.

FAQs

What are the key findings of the NETTER-2 trial?

The NETTER-2 trial showed that the combination of Lutathera and octreotide significantly extended median progression-free survival to 22.8 months and increased the objective response rate to 43%, compared to high-dose octreotide alone[3][4].

How is the global octreotide market expected to grow?

The global octreotide market is expected to grow at a CAGR of around 6% from 2021 to 2033, reaching USD 3.4 billion by 2033[5].

Which region is expected to be the fastest-growing market for somatostatin analogs?

The Asia-Pacific region is anticipated to be the fastest-growing market, driven by the rising prevalence of hormonal disorders and NETs, and the expansion of healthcare infrastructure[5].

What are the main applications of somatostatin analogs?

The main applications include acromegaly, neuroendocrine tumors (NETs), and other conditions like carcinoid syndrome[5].

What is the potential market opportunity for Lutathera as a first-line treatment?

Novartis estimates that Lutathera could achieve more than $1 billion in peak sales as a first-line therapy for GEP-NETs[3].

Sources

1. NCI: Lutathera Delays Growth of Advanced Neuroendocrine Tumors - NCI
2. Grand View Research: Somatostatin Analogs Market Size, Share & Trends Analysis Report
3. FiercePharma: Novartis eyes $1B Lutathera acceleration with trial win in newly diagnosed neuroendocrine tumors
4. Novartis: Novartis Lutathera® significantly reduced risk of disease progression or death by 72% as first-line treatment in patients with advanced gastroenteropancreatic neuroendocrine tumors
5. DataHorizzonResearch: Octreotide Market Size, Share & Forecast 2033