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
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
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

Clinical Trial Conditions for OCTREOSCAN

Condition Name

Condition Name for OCTREOSCAN
Intervention	Trials
Neuroendocrine Tumors	7
Cushing Syndrome	2
Multiple Endocrine Neoplasia Type 2A	1
Recurrent Islet Cell Carcinoma	1

Condition MeSH

Condition MeSH for OCTREOSCAN
Intervention	Trials
Neuroendocrine Tumors	12
Carcinoid Tumor	9
Neoplasms	5
Carcinoma	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
Austria	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

Clinical Trials Update, Market Analysis, and Projection for Octreoscan

Last updated: October 28, 2025

Introduction

Octreoscan, a diagnostic imaging agent containing radiolabeled octreotide, is designed for the detection and localization of neuroendocrine tumors (NETs). Approved initially in 1994, it has become a key tool for somatostatin receptor scintigraphy, offering clinicians a non-invasive method to identify tumor spread and assess treatment responses. As the landscape of diagnostic imaging advances, a comprehensive understanding of the clinical trial landscape, market dynamics, and future projections for Octreoscan is vital for stakeholders including pharmaceutical companies, investors, and healthcare providers.

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Clinical Trials Landscape and Updates

Historical Clinical Validation

Octreoscan has a robust approval history, backed by clinical trials demonstrating high sensitivity and specificity in detecting NETs. Pivotal studies established it as a standard diagnostic tool in cancer imaging, aligning with its FDA approval and widespread clinical adoption.

Recent Clinical Trials and Innovations

Recent years have seen limited new Phase I/II trials directly involving Octreoscan, primarily due to its established market position. However, ongoing investigations focus on comparative effectiveness, combination with newer imaging modalities, and expanding indications. For example, recent trials explore its integration with positron emission tomography (PET) imaging, notably with synthetic somatostatin receptor radiotracers such as 68Ga-DOTATATE, which offer higher resolution and sensitivity.

A notable clinical trial registered at ClinicalTrials.gov (Identifier: NCT04288872) evaluates the diagnostic accuracy of 68Ga-DOTATATE PET/CT versus traditional Octreoscan in detecting NETs. Preliminary results suggest superior sensitivity with PET-based imaging, which is influencing market dynamics by potentially displacing Octreoscan in certain indications.

Regulatory and Developmental Pathways

Despite the emergence of PET-based SPECT alternatives, Octreoscan remains a regulatory standard in many regions. Its stability and extensive clinical validation mean ongoing interest in its application persist, particularly in regions with limited access to PET technology. Still, there is limited active clinical development aimed specifically at improving or expanding Octreoscan's labeling, reflecting a shift toward newer, more sensitive agents.

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Market Analysis

Current Market Overview

The global somatostatin receptor scintigraphy market, driven predominantly by OCTREOSCAN, was valued at approximately USD 150 million in 2022. The primary markets include North America, Europe, and parts of Asia-Pacific, where established clinical pathways utilize Octreoscan for NET management.

Competitive Landscape

The core competitor has shifted toward PET radiotracers, such as 68Ga-DOTATATE, 68Ga-DOTATOC, and 64Cu-DOTATATE, which offer improved imaging resolution. These agents are reimbursed differently across regions, with countries like the U.S. and parts of Europe increasingly favoring PET because of its superior diagnostic capabilities.

Notwithstanding, Octreoscan remains predominant in regions where PET infrastructure is limited, especially in parts of Asia, Africa, and Latin America. The existing installed base of gamma cameras supports continued usage, especially where cost factors restrict transition to PET.

Market Drivers

• Increasing Incidence of NETs: The rising prevalence of neuroendocrine tumors, partly due to better diagnostic awareness and improved detection methodologies, sustains demand for receptor imaging agents.
• Regulatory Approvals and Guidelines: Clinical guidelines endorse somatostatin receptor scintigraphy as a first-line imaging modality for NETs, reinforcing market stability.
• Aging Population: An aging demographic prone to NETs expands the potential patient pool.

Market Challenges

• Technological Shift: The adoption of PET-based agents, backed by clinical superiority, poses a significant threat.
• Reimbursement Policies: Reimbursement disparities hamper widespread adoption, primarily where PET agents are preferred.
• Limited Pipeline Development: With the advent of newer imaging agents, pharmaceutical innovation directed toward Octreoscan is minimal, risking obsolescence.

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Market Projections (2023-2030)

Short-Term Outlook (2023-2025)

Demand remains stable predominantly in emerging markets and low-resource settings. However, in mature markets, incremental declines are anticipated as PET radiotracers gain prominence. During this period, the global market for Octreoscan is projected to decline at a compound annual growth rate (CAGR) of approximately 2-3%, primarily driven by replacement in high-income regions.

Medium to Long-Term Outlook (2026-2030)

The overall market is likely to contract further, with projections indicating a CAGR of -4% to -6%, driven by:

• Increasing clinical adoption of PET imaging.
• Regulatory approvals consolidating PET as the standard of care.
• Potential market shrinkage in regions transitioning from SPECT to PET technology.

However, Octreoscan will retain niche applications:

• Use in areas where PET infrastructure is limited.
• As a backup or complementary tool in certain diagnostic pathways.
• In resource-constrained settings, where cost advantages sustain demand.

Opportunities and Strategic Considerations

• Dual-Modality Use: Companies might explore dual-labeled agents or collaborations to enhance compatibility with multiple imaging platforms.
• Regional Expansion: Developing markets may continue to rely on Octreoscan, providing steady revenue streams.
• Product Differentiation: Emphasizing long-term stability, established clinical evidence, and broader access could sustain its relevance.

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Conclusion

Octreoscan's clinical legacy and diagnostic reliability secure its continued relevance, especially in underserved regions. Nonetheless, the evolving landscape, marked by the superiority of PET-based agents, suggests a gradual decline in its global market share over the next decade. Stakeholders should recognize opportunities within emerging markets and leverage its established safety profile and clinical validation to maintain sustained revenues amidst shifting technological standards.

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Key Takeaways

• Clinical Status: While Octreoscan remains validated and widely used, recent trials favor PET-based somatostatin receptor imaging, potentially diminishing Octreoscan's role.
• Market Dynamics: The global market is gradually contracting due to technological advancements, regulatory shifts, and infrastructure investments favoring PET agents.
• Regional Variations: Demand persists primarily in low-resource and emerging markets where PET coverage remains limited.
• Strategic Outlook: Focusing on regions still relying on SPECT, exploring dual-modality opportunities, and emphasizing the agent’s established clinical validation can sustain market relevance.
• Future Location: The overall trajectory indicates a decline but potential niche stability in specific markets over the medium term.

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FAQs

1. Will Octreoscan be replaced entirely by PET-based imaging agents?
While PET agents like 68Ga-DOTATATE offer superior sensitivity and resolution, Octreoscan will persist as a diagnostic option in regions lacking PET infrastructure. Complete replacement is unlikely in the near term, especially in low-resource settings.

2. Are there ongoing efforts to improve Octreoscan’s technology?
Currently, innovation efforts focus on developing new imaging agents rather than improving existing Octreoscan formulations. The trend favors newer radiotracers with better imaging qualities.

3. What is the reimbursement outlook for Octreoscan?
Reimbursements favor PET radiotracers in many high-income countries, accelerating substitution. However, reimbursement in regions where older imaging methods are standard ensures continued demand for Octreoscan.

4. How does the rise of PET imaging impact the clinical management of neuroendocrine tumors?
PET offers higher sensitivity, enabling earlier and more accurate detection of NETs, leading to improved treatment planning and patient outcomes, which could marginalize SPECT-based imaging like Octreoscan.

5. What are the key considerations for pharmaceutical companies regarding Octreoscan?
Companies should evaluate regional market needs, technological transitions, and partnerships to optimize their portfolio—either maintaining niche applications or transitioning focus to newer agents.

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References

1. [1] ClinicalTrials.gov. (2022). Comparative studies of somatostatin receptor imaging agents.
2. [2] MarketsandMarkets. (2022). Somatostatin receptor imaging market analysis.
3. [3] FDA. (1994). Octreoscan approval documents.
4. [4] European Medicines Agency. (2016). Guidelines on neuroendocrine tumor imaging.