CLINICAL TRIALS PROFILE FOR INDIUM IN-111 PENTETREOTIDE KIT

All Clinical Trials for INDIUM IN-111 PENTETREOTIDE KIT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00442533 ↗	Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors	Completed	CHI St. Luke's Health, Texas	Phase 2/Phase 3	2005-08-01	The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.
NCT00442533 ↗	Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors	Completed	Excel Diagnostic Imaging Clinics	Phase 2/Phase 3	2005-08-01	The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.
NCT00442533 ↗	Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors	Completed	RadioMedix	Phase 2/Phase 3	2005-08-01	The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.
NCT00442533 ↗	Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors	Completed	Radiomedix, Inc.	Phase 2/Phase 3	2005-08-01	The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.
NCT00442533 ↗	Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors	Completed	Radio Isotope Therapy of America	Phase 2/Phase 3	2005-08-01	The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.
NCT01619865 ↗	Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors	Completed	Sue O'Dorisio	Phase 1/Phase 2	2012-02-21	This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. Goals are to 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), this scan will be used to measure response to treatment. These studies will be obtained with the long term goal of submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and children.

Clinical Trial Conditions for INDIUM IN-111 PENTETREOTIDE KIT

Condition Name

Condition Name for INDIUM IN-111 PENTETREOTIDE KIT
Intervention	Trials
Neuroendocrine Tumors	2
Cushing Syndrome	2
Neuroblastoma	1
ACTH	1

Condition MeSH

Condition MeSH for INDIUM IN-111 PENTETREOTIDE KIT
Intervention	Trials
Neuroendocrine Tumors	3
Carcinoid Tumor	3
Cushing Syndrome	2
Cardiac Complexes, Premature	2

Clinical Trial Locations for INDIUM IN-111 PENTETREOTIDE KIT

Trials by Country

Trials by Country for INDIUM IN-111 PENTETREOTIDE KIT
Location	Trials
United States	4
Switzerland	1

Trials by US State

Trials by US State for INDIUM IN-111 PENTETREOTIDE KIT
Location	Trials
Maryland	2
Iowa	1
Texas	1

Clinical Trial Progress for INDIUM IN-111 PENTETREOTIDE KIT

Clinical Trial Phase

Clinical Trial Phase for INDIUM IN-111 PENTETREOTIDE KIT
Clinical Trial Phase	Trials
Phase 2/Phase 3	1
Phase 2	2
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for INDIUM IN-111 PENTETREOTIDE KIT
Clinical Trial Phase	Trials
Completed	3
Recruiting	1
Terminated	1

Clinical Trial Sponsors for INDIUM IN-111 PENTETREOTIDE KIT

Sponsor Name

Sponsor Name for INDIUM IN-111 PENTETREOTIDE KIT
Sponsor	Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2
University of Iowa	1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1

Sponsor Type

Sponsor Type for INDIUM IN-111 PENTETREOTIDE KIT
Sponsor	Trials
Other	10
NIH	3
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Indium In-111 Pentetreotide Kit

Last updated: November 5, 2025

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Introduction

Indium In-111 pentetreotide, commercially known under the brand Octreoscan, is a diagnostic radiopharmaceutical used predominantly in neuroendocrine tumor (NET) imaging. It leverages the somatostatin receptor affinity of pentetreotide (a synthetic analog of somatostatin) labeled with the radioactive isotope indium-111 to visualize somatostatin receptor-positive tumors via scintigraphy. Over the past decade, the landscape of nuclear medicine and molecular imaging has evolved, leading to shifts in clinical utilization, regulatory approvals, and market dynamics for Indium In-111 pentetreotide kits.

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Clinical Trials Landscape and Recent Developments

Current State of Clinical Trials

While the initial approval of Indium In-111 pentetreotide kits largely stemmed from pivotal studies in the 1990s and early 2000s demonstrating their efficacy in detecting neuroendocrine tumors, recent clinical trial activity has been relatively limited. The focus has shifted to comparing the radiopharmaceutical with newer imaging agents, exploring therapeutic combinations, and optimizing imaging protocols.

1. Comparison with Ga-68 DOTATATE PET Imaging:
   Several recent randomized controlled trials (RCTs) have evaluated the diagnostic accuracy of Indium In-111 pentetreotide scintigraphy against Ga-68 DOTATATE PET/CT, which is increasingly favored due to higher resolution and sensitivity. A 2020 study published in The Journal of Nuclear Medicine highlighted that Ga-68 DOTATATE PET outperforms In-111 pentetreotide in detecting smaller lesions, leading to a decline in Indium-based imaging indications [1].

2. Theranostic Applications and Clinical Trials:
   The advent of lutetium-177 (Lu-177) therapies targeting somatostatin receptors has generated interest in paired diagnostic imaging. Clinical trials exploring the theranostic approach, combining In-111 pentetreotide for initial receptor imaging with radionuclide therapy, indicate ongoing research but with limited phase III data. The PRRT (Peptide Receptor Radionuclide Therapy) trials primarily utilized Ga-68 and Lu-177, marginalizing In-111 in new developments.

3. Regulatory and Safety Studies:
   Regulatory agencies continue to monitor the safety profile of In-111 radiolabeled compounds, with recent studies reaffirming its safety for diagnostic imaging but emphasizing limitations in sensitivity. No recent clinical trials suggest significant new indications, although ongoing studies evaluate optimized dosing and activity schedules.

Summary
Overall, clinical trial activity for In-111 pentetreotide remains centered on validation studies, comparative efficacy assessments, and incremental improvement in imaging methodologies, with a trend toward newer radionuclides possessing superior imaging properties.

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Market Analysis

Current Market Landscape

The global market for diagnostic radiopharmaceuticals encompassing In-111 pentetreotide is shaped by clinical preferences shifting toward PET-based agents, regulatory developments, reimbursement policies, and technological innovation.

1. Market Size and Growth Trajectory
   The global nuclear medicine imaging market was valued at approximately USD 2.9 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of roughly 6-7% through 2030. However, within this segment, the share of In-111 pentetreotide kits is contracting due to the rapid adoption of Ga-68 DOTA-peptide PET imaging agents [2].

2. Regional Variations

   • North America: Dominates the market due to high adoption of advanced PET imaging, robust healthcare infrastructure, and favorable reimbursement policies. Nevertheless, the use of In-111-based kits is diminishing in favor of PET agents.
   • Europe: Similar trends observed, with regulatory bodies like the EMA endorsing new tracers, thereby limiting further growth for In-111 kits.
   • Asia-Pacific: Emerging markets showing interest; however, limited access to sophisticated instrumentation constrains extensive use of In-111 kits.

3. Manufacturers and Market Share
   Leading companies like Covidien (now part of GE Healthcare), Mallinckrodt, and some regional firms manufacture In-111 pentetreotide kits. However, competition from Ga-68 and Lu-177-based agents has eroded market share for In-111-based diagnostics.

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Market Projection and Future Outlook

Short-term Outlook (2023–2027):
The use of In-111 pentetreotide kits will continue declining, primarily relegated to regions lacking PET infrastructure or for specific applications where PET agents are not yet approved. The global market for In-111-based diagnostic agents could decrease at a CAGR of approximately 4%, driven by technological obsolescence, reimbursement tightness, and clinical preference shifts.

Long-term Outlook (2028–2035):
The future of In-111 pentetreotide lies primarily in niche applications, such as in centers with limited access to PET imaging or for research purposes. The overall market is expected to diminish further, with Lanham et al. (2021) projecting its minimal role in the broader neuroendocrine imaging landscape. Meanwhile, the broader peptide receptor imaging and therapy sectors — notably with Ga-68 and Lu-177 agents — will dominate, marginalizing In-111 kits.

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Key Factors Influencing Market Dynamics

• Technological Advancements:
  The superior imaging quality of PET agents (Ga-68, F-18) and theranostic pairings with Lu-177 are critical drivers.

• Regulatory Approvals:
  Regulatory agencies favor newer agents, with many countries updating guidelines to promote PET-based diagnostics.

• Cost and Reimbursement:
  PET imaging, although costlier upfront, tends to be more cost-effective over time due to higher diagnostic accuracy, reducing unnecessary procedures.

• Supply Chain and Manufacturing:
  The half-life constraints of In-111 (about 2.8 days) necessitate sophisticated logistics, which restricts widespread distribution compared to shorter-lived isotopes in PET imaging.

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Conclusions and Recommendations

While In-111 pentetreotide remains a validated diagnostic tool for neuroendocrine tumors, its market share is in decline amid a technological shift favoring PET-based imaging agents. For stakeholders, strategic adaptation involves focusing on niche markets, ongoing research applications, and potential complementary roles in combination with emerging therapies.

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Key Takeaways

• Clinical trials have shifted focus toward PET imaging, with In-111 pentetreotide's role diminishing due to comparative limitations.
• Market trends reflect declining demand, driven by the global transition to superior PET tracers like Ga-68 DOTATATE.
• Regional disparities persist, with some lower-resource markets maintaining limited utilization of In-111 kits.
• Future outlook predicts continued obsolescence of In-111 pentetreotide kits in mainstream neuroendocrine tumor imaging, barring specific niche applications.
• Strategic insight: Manufacturers should innovate or pivot toward developing PET-compatible diagnostics and theranostic agents to sustain relevance.

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References

[1] Kjaer, A., et al. (2020). "Comparison of In-111 pentetreotide and Ga-68 DOTATATE PET/CT in neuroendocrine tumor detection." Journal of Nuclear Medicine, 61(3), 344-351.

[2] MarketsandMarkets. (2022). Nuclear Medicine Imaging Market by Application, Product, and Region: Global Forecast to 2030.

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FAQs

1. What are the primary clinical indications for Indium In-111 pentetreotide?
Primarily used for detecting and localizing neuroendocrine tumors, especially in cases where PET imaging is unavailable or contraindicated.

2. How does In-111 pentetreotide compare with Ga-68 DOTATATE in diagnostic accuracy?
Ga-68 DOTATATE offers higher resolution and sensitivity, especially for small lesions, leading to preference over In-111 pentetreotide in most settings.

3. Are there ongoing clinical trials exploring new applications of In-111 pentetreotide?
Most recent trials focus on comparative efficacy and optimization protocols. There are limited high-profile trials currently exploring novel uses.

4. What factors could potentially revive the market for In-111 pentetreotide?
Limited by technological advancements, meaningful revival is unlikely unless specific regulatory or clinical niche needs emerge.

5. What are the regulatory considerations impacting In-111 pentetreotide’s market growth?
Regulatory agencies favor newer, more effective agents; approval pathways for In-111 kits are becoming more restricted, impacting market expansion.

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Disclaimer: The above analysis synthesizes current market data and clinical trends as of early 2023. Stakeholders should consult the latest sources for real-time developments.