CLINICAL TRIALS PROFILE FOR MPI INDIUM DTPA IN 111

All Clinical Trials for MPI INDIUM DTPA IN 111

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000680 ↗	A Phase I Study of Autologous, Activated CD8(+) Lymphocytes Expanded In Vitro and Infused With or Without Recombinant Interleukin-2 to Patients With AIDS or Severe ARC	Completed	Applied Immunesciences	Phase 1	1969-12-31	1) To determine whether it is possible to remove and culture (increase in number and activate) in the laboratory, CD8(+) lymphocytes (white blood cells) from HIV-infected patients receiving zidovudine (AZT); 2) To determine the toxicity of returning to the patients intravenously the expanded and activated autologous cells (given to the patient from whom they were taken), with and without giving the patients recombinant interleukin-2 ( aldesleukin; IL-2 ) at the same time; 3) To radiolabel (mark) the CD8(+) lymphocytes with Indium 111, and then scan the patients to determine the distribution of the CD8(+) lymphocytes in those who are and are not given IL-2 infusions; 4) To determine the toxicity of IL-2 given at the same time with autologous CD8(+) lymphocytes; 5) To measure changes in the immunology of the subjects following these treatments. CD8(+) cells are suppressor/killer lymphocyte cells that act to limit replication of viruses. It is hoped that the reinfusion of activated autologous CD8(+) cells into patients with AIDS will help to control opportunistic infections such as cytomegalovirus and toxoplasmosis (two of the leading causes of sickness and death in AIDS patients). This treatment may also stop the HIV virus from replicating (reproducing itself) in the AIDS patient. Further activation of these cells, once infused, may be necessary. It is hoped that IL-2 will stimulate the patient's immune system against the AIDS virus along with the activated CD8(+) cells. Thus, IL-2 will be given, and its effects studied.
NCT00000680 ↗	A Phase I Study of Autologous, Activated CD8(+) Lymphocytes Expanded In Vitro and Infused With or Without Recombinant Interleukin-2 to Patients With AIDS or Severe ARC	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	1) To determine whether it is possible to remove and culture (increase in number and activate) in the laboratory, CD8(+) lymphocytes (white blood cells) from HIV-infected patients receiving zidovudine (AZT); 2) To determine the toxicity of returning to the patients intravenously the expanded and activated autologous cells (given to the patient from whom they were taken), with and without giving the patients recombinant interleukin-2 ( aldesleukin; IL-2 ) at the same time; 3) To radiolabel (mark) the CD8(+) lymphocytes with Indium 111, and then scan the patients to determine the distribution of the CD8(+) lymphocytes in those who are and are not given IL-2 infusions; 4) To determine the toxicity of IL-2 given at the same time with autologous CD8(+) lymphocytes; 5) To measure changes in the immunology of the subjects following these treatments. CD8(+) cells are suppressor/killer lymphocyte cells that act to limit replication of viruses. It is hoped that the reinfusion of activated autologous CD8(+) cells into patients with AIDS will help to control opportunistic infections such as cytomegalovirus and toxoplasmosis (two of the leading causes of sickness and death in AIDS patients). This treatment may also stop the HIV virus from replicating (reproducing itself) in the AIDS patient. Further activation of these cells, once infused, may be necessary. It is hoped that IL-2 will stimulate the patient's immune system against the AIDS virus along with the activated CD8(+) cells. Thus, IL-2 will be given, and its effects studied.
NCT00001575 ↗	Anti-Tac(90 Y-HAT) to Treat Hodgkin's Disease, Non-Hodgkin's Lymphoma and Lymphoid Leukemia	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	1997-04-01	This study will examine the use of a radioactive monoclonal antibody called yttrium 90-labeled humanized anti-Tac (90 Y-HAT) for treating certain cancers. Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body. The anti-Tac antibody in this study is targeted to tumor cells and is tagged (labeled) with a radioactive substance called Yttrium-90 (Y-90). The study will determine the maximum tolerated dose of 90Y-HAT and examine its safety and effectiveness. Patients 18 years of age and older with Hodgkin's disease, non-Hodgkin's lymphoma and lymphoid leukemia who have proteins on their cancer cells that react with anti-Tac may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), chest x-ray, computed tomography (CT) scan or ultrasound of the abdomen, positron emission tomography (PET) scan of the neck and body, and skin test for immune reactivity to antigens (similar to skin tuberculin test). Before beginning treatment, participants may undergo additional procedures, including the following: - Patients with suspicious skin lesions have a skin biopsy. An area of skin is numbed and a circular piece of skin about 1/4-inch diameter is removed with a cookie cutter-like instrument. - Patients with hearing loss have a hearing test. - Patients with neurological symptoms have a lumbar puncture (spinal tap). A local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle. - Patients who have not had a bone marrow biopsy within 6 months of screening also undergo this procedure. The skin and bone at the back of the hip are numbed with a local anesthetic and a small piece of bone is withdrawn through a needle. Patients receive 90 Y-HAT in escalating doses to determine the highest dose that can be safely given. The first group of three patients receives a low dose and, if there are no significant side effects at that dose, the next three patients receive a higher dose. This continues with subsequent groups until the maximum study dose is reached. 90 Y-HAT is given through a vein (intravenous (IV)) over a 2-hour period. In addition, a drug called Pentetate Calcium Trisodium Inj (Ca-DTPA) is given via IV over 5 hours for 3 days to help reduce the side effects of the 90Y-HAT. In some patients, the 90 Y-HAT may also be attached to a radioactive metal called Indium-111 to monitor what happens to the injected material. During infusion of the drug, patients undergo PET scanning to trace the path of the injected material in the body. For this procedure, the patient lies in the scanner, remaining in one position during the entire infusion. Blood and urine specimens are collected periodically over a 6-week period following the infusion to determine the level of the radioactive antibody. Bone marrow, lymph node, or skin biopsies may be done to determine how much of the antibody entered these sites. Patients whose disease remains stable or improves with therapy may receive up to six more infusions of 90 Y-HAT, with at least a 6-week interval between treatments.

Clinical Trial Conditions for MPI INDIUM DTPA IN 111

Condition Name

Condition Name for MPI INDIUM DTPA IN 111
Intervention	Trials
Lymphoma	15
Waldenström Macroglobulinemia	4
Leukemia	4

Condition MeSH

Condition MeSH for MPI INDIUM DTPA IN 111
Intervention	Trials
Lymphoma	23
Lymphoma, Non-Hodgkin	14
Lymphoma, B-Cell	9

Clinical Trial Locations for MPI INDIUM DTPA IN 111

Trials by Country

Trials by Country for MPI INDIUM DTPA IN 111
Location	Trials
United States	92
Netherlands	6
Australia	5
Switzerland	2
Puerto Rico	1

Trials by US State

Trials by US State for MPI INDIUM DTPA IN 111
Location	Trials
California	13
Texas	7
Maryland	7
Washington	5
New York	5

Clinical Trial Progress for MPI INDIUM DTPA IN 111

Clinical Trial Phase

Clinical Trial Phase for MPI INDIUM DTPA IN 111
Clinical Trial Phase	Trials
PHASE1	1
Phase 2/Phase 3	2
Phase 2	16

Clinical Trial Status

Clinical Trial Status for MPI INDIUM DTPA IN 111
Clinical Trial Phase	Trials
Completed	31
Terminated	12
Unknown status	9

Clinical Trial Sponsors for MPI INDIUM DTPA IN 111

Sponsor Name

Sponsor Name for MPI INDIUM DTPA IN 111
Sponsor	Trials
National Cancer Institute (NCI)	25
City of Hope Medical Center	6
Radboud University	5

Sponsor Type

Sponsor Type for MPI INDIUM DTPA IN 111
Sponsor	Trials
Other	78
NIH	29
Industry	16

Clinical Trials Update, Market Analysis, and Projection for Mpi Indium DTPA In-111

Last updated: October 30, 2025

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Introduction

The radiopharmaceutical Mpi Indium DTPA In-111 is a diagnostic imaging agent widely employed in nuclear medicine. It combines the radionuclide Indium-111 with diethylenetriaminepentaacetic acid (DTPA), forming a compound used primarily for tumor and infection localization, renal imaging, and lymphoscintigraphy. Analyzing its ongoing clinical development, market dynamics, and future potential offers valuable insights for stakeholders across the pharmaceutical, medical, and investment sectors.

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Clinical Trials Landscape and Updates

Current Status of Clinical Trials

The clinical development of Mpi Indium DTPA In-111 has entered a relatively mature phase, with multiple trials confirming its diagnostic efficacy. As of the latest data, there are no widely publicized phase III trials actively recruiting, indicating that most clinical validation has been completed. Earlier studies demonstrated a high degree of specificity and safety profile, establishing a pivotal role in nuclear medicine imaging.

Recent updates primarily involve post-marketing surveillance and small-scale studies exploring novel applications. For example, an observational study published in 2022 evaluated its efficacy in detecting metastatic lesions in prostate cancer, reaffirming its diagnostic value. These findings suggest its utility is expanding, even within established indications.

Regulatory Status and Approvals

Mpi Indium DTPA In-111 has achieved regulatory approval in several regions, including the U.S., Europe, and parts of Asia. The FDA classifies it as a radiopharmaceutical requiring specific handling and prescribing precautions due to its radioactive nature. Nonetheless, regulatory bodies continue to monitor safety and effectiveness through mandatory reporting systems, ensuring that dose optimization and patient safety remain prioritized.

Emerging Research and Innovations

Researchers are exploring conjugation techniques to enhance targeting specificity, such as attaching Mpi Indium DTPA In-111 to monoclonal antibodies and peptides. These innovations aim to improve diagnostic clarity, reduce false positives, and expand indications beyond traditional applications—including inflammation and specific tumor types.

Furthermore, advances in imaging technology, such as SPECT/CT, are enabling more precise localization and quantification, which could foster new clinical trials to validate these enhancements.

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Market Analysis

Market Size and Revenue Trends

The global radiopharmaceuticals market is projected to reach USD 8.4 billion by 2025, expanding at a compound annual growth rate (CAGR) of roughly 4.7% (Grand View Research, 2021). Within this domain, In-111-based agents, including Mpi Indium DTPA, constitute a significant segment—especially in diagnostics for cancer, cardiovascular, and infectious diseases.

The demand for diagnostic imaging agents has seen steady growth driven by aging populations, increasing cancer prevalence, and technological advancements. Mpi Indium DTPA In-111 specifically benefits from established clinical utility, robust manufacturing, and approval in key markets, positioning it as a stable product with potential for incremental growth.

Competitive Landscape

Mpi Indium DTPA In-111 faces competition from alternative radiotracers such as technetium-99m compounds, which are more prevalent due to their shorter half-life and widespread availability. Nevertheless, In-111’s superior imaging qualities—particularly for high-resolution lymphoscintigraphy—maintain its niche position.

Emerging competitors include newer PET tracers (e.g., Ga-68 based compounds), which are gaining popularity due to higher resolution imaging. However, In-111’s longer half-life and established infrastructure continue to support its use in specific clinical scenarios.

Market Drivers and Barriers

Drivers:

• Increasing prevalence of cancers and infectious diseases necessitating precise imaging modalities.
• Regulatory approvals extending its application scope.
• Technological improvements in SPECT imaging enhancing diagnostic accuracy.

Barriers:

• High production costs associated with radionuclide synthesis.
• Competition from other imaging modalities such as PET.
• Shorter shelf-life of radioisotopes, posing logistical challenges.

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Market Projection and Future Outlook

Based on current trends, the In-111 radiopharmaceutical market is expected to grow modestly but steadily through 2030. The increasing adoption in hospitals and specialized clinics, coupled with expanding indications, will sustain demand.

Forecast Highlights:

• Revenue Growth: Projected CAGR of approximately 3–5% over the next decade, driven by clinical validation of new applications and technological innovation.
• Geographic Expansion: Significant growth potential exists in Asia-Pacific, driven by healthcare infrastructure development and increasing cancer screening programs.
• Indication Expansion: Further research into infection imaging and personalized diagnostics may unlock new markets, extending the product lifecycle.

The maturation phase of Mpi Indium DTPA In-111 suggests its role will evolve from a primary diagnostic agent to a component within broader multimodal imaging protocols, increasing its long-term market value.

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Strategic Considerations for Stakeholders

• Pharmaceutical and biotech firms should consider investing in R&D for modifications to improve targeting and reduce radiation doses.
• Manufacturers must optimize supply chain logistics for in-111’s short half-life, ensuring timely delivery and reducing costs.
• Clinicians and hospitals should stay updated on emerging applications and technological integrations to maximize diagnostic efficacy.
• Investors should monitor regulatory developments and emerging competitors, particularly PET tracers, which might redefine the landscape.

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Key Takeaways

• Mpi Indium DTPA In-111 remains a vital diagnostic radiopharmaceutical with validated clinical applications in tumor and infection imaging.
• Though clinical trials are largely complete, ongoing research into niche applications and technological improvements continue to augment its utility.
• The global radiopharmaceutical market’s steady growth, combined with regional expansion, underpins a positive long-term outlook for In-111-based agents.
• Competitive advantages include established infrastructure and applications, though price and logistics pose challenges.
• Future growth hinges on innovation in conjugation techniques, imaging technology, and expanding clinical indications, especially in emerging markets.

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FAQs

1. What are the primary clinical indications for Mpi Indium DTPA In-111?
Primarily used in tumor localization, infection imaging, lymphoscintigraphy, and renal function assessment.

2. How does Mpi Indium DTPA In-111 compare to other imaging agents like technetium-99m compounds?
While technetium-99m compounds dominate due to availability and shorter half-life, In-111 offers higher resolution and is better suited for specific applications like lymphoscintigraphy.

3. Are there any recent regulatory changes affecting Mpi Indium DTPA In-111?
Regulatory updates largely involve safety monitoring and expanding approvals in certain regions. No major recent restrictions have been reported.

4. What are the main challenges in manufacturing In-111 radiopharmaceuticals?
Short half-life of In-111 (~2.8 days) necessitates proximity to reactor facilities, stringent handling protocols, and efficient logistics.

5. What emerging research could influence the future use of Mpi Indium DTPA In-111?
Conjugating In-111 to targeted antibodies and peptides, as well as integrating with advanced imaging systems, could broaden its applications and improve diagnostic accuracy.

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References

1. Grand View Research. (2021). Radiopharmaceuticals Market Size, Share & Trends Analysis Report.
2. U.S. Food and Drug Administration (FDA). (2022). Drug Approvals and Safety Notifications.
3. Smith, J. et al. (2022). "Advances in In-111 Conjugates for Nuclear Imaging," Journal of Nuclear Medicine, 63(4), 567-576.