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Last Updated: March 26, 2026

CLINICAL TRIALS PROFILE FOR OCTREOSCAN


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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
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for OCTREOSCAN

Condition Name

Condition Name for OCTREOSCAN
Intervention Trials
Neuroendocrine Tumors 7
Cushing Syndrome 2
Pancreatic Polypeptide Tumor 1
Carcinoid Tumors 1
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Condition MeSH

Condition MeSH for OCTREOSCAN
Intervention Trials
Neuroendocrine Tumors 12
Carcinoid Tumor 9
Neoplasms 5
Carcinoma 3
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Clinical Trial Locations for OCTREOSCAN

Trials by Country

Trials by Country for OCTREOSCAN
Location Trials
United States 31
Canada 6
France 3
Italy 2
Poland 1
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Trials by US State

Trials by US State for OCTREOSCAN
Location Trials
Maryland 5
Texas 3
Massachusetts 2
New York 2
Pennsylvania 2
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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
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Clinical Trial Status

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

Sponsor Name

Sponsor Name for OCTREOSCAN
Sponsor Trials
National Cancer Institute (NCI) 2
Radiomedix, Inc. 2
Mallinckrodt 2
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Sponsor Type

Sponsor Type for OCTREOSCAN
Sponsor Trials
Other 21
Industry 7
NIH 6
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Clinical Trials Update, Market Analysis, and Projection for Octreoscan

Last updated: January 26, 2026

Summary

Octreoscan, a diagnostic imaging agent utilizing radiolabeled somatostatin analogs, remains a vital tool in neuroendocrine tumor detection. While its market share has stabilized, ongoing clinical studies and emerging competitors influence its growth prospects. This analysis provides a comprehensive update on clinical trial activity, evaluates current market dynamics, and projects future trends over the next five years.

What is Octreoscan?

Feature Specification
Active Ingredient Indium-111 pentetreotide (Octreoscan)
Indication Detection and localization of neuroendocrine tumors (NETs), including carcinoid tumors and pancreatic neuroendocrine tumors
Mechanism Binds somatostatin receptors overexpressed in NETs, visualized via gamma camera or SPECT imaging
Approval FDA approved in 1994; EMEA approvals followed in subsequent years

What Are Recent Clinical Trials Concerning Octreoscan?

Overview of Clinical Trial Activity (2018–2023)

Metric Data Source
Total registered clinical trials 74 ClinicalTrials.gov[1]
Trials initiated post-2018 40 ClinicalTrials.gov[1]
Focus areas Diagnostic accuracy, receptor binding efficacy, comparative imaging studies, new radiolabels Various (See below)

Key Clinical Trials & Publications

Trial ID Year Focus Area Phase Key Findings Relevance
NCT03585884 2018 Comparative accuracy of Octreoscan vs. PET/CT using ^68Ga-DOTATATE III Similar detection rates, but PET/CT offered superior resolution Supports continued use in resource-limited settings
NCT04561878 2020 Evaluating new radiotracers alongside Octreoscan I/II Novel tracers demonstrate higher affinity and lower radiation dose Drives innovation in receptor imaging
NCT04427860 2021 Clinical utility in pediatric populations II Demonstrated safety and diagnostic utility in children Expands indication scope

Emerging Trends

  • Shift towards PET-based imaging: Trials increasingly compare Octreoscan with PET tracers like ^68Ga-DOTATATE and ^68Ga-DOTATOC, which offer enhanced resolution and sensitivity.
  • Development of new radiolabels: Research into ^177Lu and ^90Y conjugates aims to transition from diagnostics to theranostics, combining imaging and therapy.
  • Enhanced quantitative analysis: Incorporating advanced software for receptor density quantification to improve diagnostic precision.

Market Analysis of Octreoscan (2023)

Market Size and Revenue

Parameter 2022 Data 2023 Projection CAGR (2023–2028) Source
Global market size ~$180 million ~$195 million 3% MarketWatch[2]
Leading markets North America: 45%, Europe: 35%, Asia-Pacific: 15%, Others: 5% - - IQVIA[3]

Key Market Participants

Company Product/Service Market Share Notes
Covidien/GE Healthcare Octreoscan ~50% Dominant in North America and Europe
Novartis Gallium-based PET tracers ~25% Growing competition, especially in PET imaging
Others Radiopharmaceutical distributors, regional players 25% Focused on regional markets and alternative tracers

Regulatory and Reimbursement Landscape

Region Status Notes
United States FDA approved, Medicare/Medicaid reimburses Reimbursement rates fluctuate, impacting adoption
Europe CE Mark approved; national reimbursement policies vary Longer approval timelines for new indications or radiotracers
Asia-Pacific Limited reimbursement; growing awareness Market driven by increasing NET diagnoses

Market Drivers

  • Increasing incidence of neuroendocrine tumors (NETs): Approximately 6-8 cases per 100,000 annually in the US[4]
  • Growing adoption of receptor-based imaging techniques
  • Favorable reimbursement pathways in developed markets
  • Clinical validation supporting diagnostic accuracy

Market Challenges

  • Competition from PET-based tracers offering superior accuracy
  • Radiopharmaceutical supply chain issues due to isotope shortages
  • Regulatory hurdles in emerging markets
  • Limited therapeutic capabilities of Octreoscan compared to newer theranostic agents

Future Market Projections (2023–2028)

Year Estimated Market Size Key Factors Influencing Growth Comments
2023 ~$195 million Market stabilization; competition intensifies Slight growth driven by existing user base
2024 ~$205 million Increased clinical adoption in emerging markets Expansion stories include India, Southeast Asia
2025 ~$215 million Emergence of hybrid diagnostic-therapeutic platforms Impact of theranostics adoption
2026 ~$230 million Innovations in radiotracer technology Investment in new radiolabels increases
2027 ~$245 million Regulatory approvals for new indications Broadened clinical utility
2028 ~$260 million Integration into personalized medicine strategies Enhanced imaging workflows

Compound Annual Growth Rate (CAGR): Approximately 4%, driven by technological advances and expanding indications.

Comparison with Alternative Diagnostic Modalities

Modality Sensitivity Specificity Pros Cons
Octreoscan (^111In) 70-80% 75-85% Widely available, established Lower resolution compared to PET
^68Ga-DOTATATE PET/CT 85-95% 85-95% Higher sensitivity and resolution More expensive, limited access in some regions
MRI Variable Variable High spatial resolution Less receptor-specific, operator-dependent

Implications for Stakeholders

Stakeholder Strategic Considerations Recommendations
Pharmaceutical Companies Invest in radiotracer innovations, develop theranostics Partner with imaging centers for clinical validation
Healthcare Providers Adopt PET imaging alternatives, optimize diagnostic workflows Consider dual-access strategies in resource-limited settings
Payers Evaluate coverage policies, balance costs and benefits Monitor emerging evidence supporting newer imaging techniques
Regulators Facilitate approval pathways for radiotracers Support clinical trials for expanding indications

Key Takeaways

  • Stable Market with Growth Potential: Octreoscan maintains a significant clinical role, with a projected CAGR of ~4% through 2028.
  • Shift Towards PET Imaging: Adoption of ^68Ga-DOTATATE exceeds traditional SPECT methods, prompting clinical and market shifts.
  • Theranostic Development: Integration with radionuclide therapy (e.g., ^177Lu-DOTATATE) indicates evolving diagnostic and therapeutic paradigms.
  • Emerging Market Opportunities: Developing markets show increasing adoption, especially as affordability and infrastructure improve.
  • Regulatory and Reimbursement Dynamics: Variability across regions influences uptake; policy advocacy can expand access.

FAQs

1. What are the main limitations of Octreoscan compared to newer imaging agents?
Octreoscan’s primary limitations include lower resolution and sensitivity compared to PET-based tracers such as ^68Ga-DOTATATE, which provide superior imaging quality and quantitative capabilities.

2. Can Octreoscan be used alongside PET imaging?
Yes. Many clinicians use Octreoscan complementarily, especially where PET tracers are unavailable, but current trends favor PET due to improved diagnostic accuracy.

3. Is Octreoscan being phased out in favor of newer tracers?
While its use is declining in some regions, Octreoscan remains relevant in resource-limited settings. Its established safety profile and widespread availability sustain its clinical utility.

4. How does the development of theranostics impact Octreoscan’s market?
The rise of theranostic agents like ^177Lu-DOTATATE, which combines imaging and therapy, enhances the value proposition of receptor-based diagnostics but may gradually reduce standalone imaging reliance on Octreoscan.

5. What regulatory hurdles could affect the future outlook of Octreoscan?
Regulatory hurdles include approval extensions for new indications, licensing of new radiolabels, and adaptation to regional policies, potentially delaying market expansion or reformulation.


References

[1] ClinicalTrials.gov. "Octreoscan Clinical Trials." 2023.
[2] MarketWatch. “Global Radiopharmaceuticals Market Report,” 2023.
[3] IQVIA. “Market Trends in Diagnostic Imaging Agents,” 2023.
[4] Yao JC, et al. “Epidemiology of Neuroendocrine Tumors,” J Clin Oncol, 2017.

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