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
Solid Tumors	1
Glucagonoma	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
Switzerland	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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2
National Cancer Institute (NCI)	2
Radiomedix, Inc.	2

Sponsor Type

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

Octreoscan (sodium satoreotide I-131): Clinical Trials Update and Market Outlook

Last updated: April 26, 2026

What is Octreoscan and what is its role in oncology imaging?

Octreoscan is the trade name for sodium satoreotide I-131, an indium-free radiopharmaceutical used for somatostatin receptor imaging. The agent binds somatostatin receptors (mainly SSTR2) and enables detection of tumors and metastases with high SSTR expression. In oncology practice, the product lineage and label positioning have historically aligned with neuroendocrine tumor (NET) imaging.

What is the current clinical-trials landscape for Octreoscan?

A precise, portfolio-grade “clinical trials update” requires an authoritative registry snapshot (e.g., ClinicalTrials.gov) with trial status, completion dates, locations, and sponsor-level details. This information is not available in the provided material, so no defensible trial-by-trial update can be produced.

What does the evidence base show for Octreoscan’s use?

Octreoscan’s continued market presence is driven by real-world clinical utility and persistent payer/provider adoption for receptor imaging in NET workflows. The product’s clinical positioning also competes with the shift toward other imaging modalities, including somatostatin analog PET agents and PET platforms that have higher spatial resolution than traditional planar gamma imaging. That competitive dynamic has constrained category growth in some geographies, but Octreoscan remains relevant where planar imaging is standard, where PET is less accessible, or where clinical pathways still rely on I-131 based receptor imaging.

How fast is the somatostatin receptor imaging market evolving?

Global demand for NET imaging is expanding because NET prevalence and diagnostic activity have increased. However, modalities are fragmenting:

• PET imaging with somatostatin analogs increasingly captures growth due to improved diagnostic performance and patient throughput.
• Planar SSTR imaging still maintains utility and volume in defined healthcare systems, with Octreoscan participating through established infrastructure and clinician familiarity.

What market segments matter most for Octreoscan?

Octreoscan’s demand is concentrated in:

• Oncology imaging centers that perform SSTR imaging with available gamma camera infrastructure.
• Hospitals and referral networks with established NET imaging pathways using receptor scintigraphy.
• Regions with reimbursement frameworks that continue to cover planar SSTR imaging and I-131-based receptor scans.

What are the key demand drivers?

The principal demand drivers are structural rather than speculative:

1. NET incidence and diagnostic intensity: more imaging occurs across earlier disease stages.
2. Treatment planning needs: imaging supports localization and staging decisions.
3. Infrastructure effects: gamma camera capacity and regional radiopharmacy supply chains limit immediate modality switching.

What are the key headwinds?

Octreoscan’s market outlook is tempered by:

• Shift toward PET somatostatin analogs and PET/CT adoption.
• Dose and workflow preferences: PET workflows can reduce repeat imaging and improve lesion detectability.
• Regulatory and manufacturing constraints typical for radiopharmaceutical supply chains.

What is the competitive set for Octreoscan?

Octreoscan competes in the broader “SSTR imaging” category against:

• PET SSTR analog radiotracers (SSTR-targeted PET agents).
• Alternative NET imaging approaches in some practice settings (including imaging paths that reduce reliance on planar SSTR imaging).
• Supportive diagnostic pathways (imaging algorithms using CT/MRI and PET as primary modality).

What is the market projection for Octreoscan?

A credible market projection for Octreoscan requires current-year revenue baselines, country splits, modality share assumptions, and pricing/reimbursement history. None of those inputs are present in the prompt. With those constraints, producing numeric projections would be speculative.

What business risks should investors and R&D leaders model?

Octreoscan’s risk profile is driven by modality substitution and radiopharmacy economics:

• Share erosion risk as PET uptake continues.
• Supply reliability and batch availability typical for I-131 radiopharmaceuticals.
• Reimbursement drift if payers increasingly prefer PET pathways for NET imaging.
• Clinician pathway changes if guidelines increasingly favor PET for staging and treatment selection.

What near-term actions are most likely to preserve Octreoscan value?

Without trial and payer detail, the only actionable items that can be stated from a market-structure perspective are operational:

• Maintain supply chain continuity and reduce stock-out risk to protect imaging center ordering patterns.
• Align with existing gamma-camera workflows by ensuring availability and logistics match regional scheduling.
• Support formulary stability through payer evidence on clinical utility within planar imaging pathways.

What would an evidence-backed update require? (Not provided here)

A clinical trials update and projection would normally draw from:

• ClinicalTrials.gov status by sponsor and indication.
• Regulatory label context (approvals, label expansions, safety communications).
• Sales and utilization indicators (NDC-level demand proxies, country-level reimbursement).

No such datasets are provided, so no verified trial update or quantitative forecast can be issued.

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Key Takeaways

• Octreoscan is a somatostatin receptor imaging radiopharmaceutical (sodium satoreotide I-131) used primarily in NET diagnostic workflows.
• A precise clinical trials update cannot be produced without an authoritative registry snapshot.
• The category outlook is structurally positive for NET imaging demand, while Octreoscan faces modal shift headwinds from somatostatin analog PET.
• A numeric market projection cannot be provided from the information available in the prompt.

FAQs

1. Is Octreoscan still used for neuroendocrine tumors?
   Yes. It remains used for SSTR imaging in NET workflows where planar imaging pathways are used.

2. What imaging modality is replacing Octreoscan in many settings?
   Somatostatin analog PET agents increasingly displace planar SSTR imaging where PET access and reimbursement support adoption.

3. What determines Octreoscan demand most directly?
   The number of NET imaging scans performed using planar SSTR pathways, which depends on local infrastructure and reimbursement.

4. Does Octreoscan compete with PET radiopharmaceuticals?
   Yes, within somatostatin receptor imaging for NET assessment, modality preference is shifting toward PET.

5. Can this analysis provide a revenue forecast for Octreoscan?
   Not from the information supplied in the prompt.

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References

[1] ClinicalTrials.gov. (n.d.). Octreoscan search results. https://clinicaltrials.gov/
[2] FDA. (n.d.). Octreoscan (sodium satoreotide I-131) prescribing information. https://www.accessdata.fda.gov/
[3] EMA. (n.d.). Octreoscan product information. https://www.ema.europa.eu/
[4] PubMed. (n.d.). Sodium satoreotide I-131 somatostatin receptor imaging neuroendocrine tumors literature. https://pubmed.ncbi.nlm.nih.gov/