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Last Updated: March 15, 2025

CLINICAL TRIALS PROFILE FOR MPI INDIUM DTPA IN 111


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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.
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.
NCT00003920 ↗ Monoclonal Antibody Therapy Plus Cyclosporine and Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Breast Cancer Unknown status University of California, Davis Phase 1 1996-04-01 RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Cyclosporine may prevent this from happening. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody plus cyclosporine and peripheral stem cell transplantation in treating patients who have metastatic breast cancer that has not responded to previous therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
Recurrent Mantle Cell Lymphoma 3
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Condition MeSH

Condition MeSH for Mpi Indium Dtpa In 111
Intervention Trials
Lymphoma 23
Lymphoma, Non-Hodgkin 14
Lymphoma, B-Cell 9
Lymphoma, Mantle-Cell 7
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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 91
Netherlands 6
Australia 5
Switzerland 2
Germany 1
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Trials by US State

Trials by US State for Mpi Indium Dtpa In 111
Location Trials
California 12
Texas 7
Maryland 7
New York 5
Pennsylvania 5
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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
Phase 2/Phase 3 2
Phase 2 16
Phase 1/Phase 2 11
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Clinical Trial Status

Clinical Trial Status for Mpi Indium Dtpa In 111
Clinical Trial Phase Trials
Completed 31
Terminated 12
Unknown status 9
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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) 24
City of Hope Medical Center 5
Radboud University 5
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Sponsor Type

Sponsor Type for Mpi Indium Dtpa In 111
Sponsor Trials
Other 76
NIH 28
Industry 15
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MPI Indium DTPA In 111: Clinical Trials, Market Analysis, and Projections

Introduction

MPI Indium DTPA In 111, also known as Pentetate Indium Disodium In 111, is a radiopharmaceutical used in various diagnostic and therapeutic applications. This article will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Applications

Detection of Infections

MPI Indium DTPA In 111 has been evaluated for the detection of infections, particularly in patients with lung infections. A study involving 33 patients, mostly with HIV infection, showed that the radiopharmaceutical could effectively identify Pneumocystis carinii pneumonia (PCP) through diffusely increased lung uptake of the tracer[1].

Intrathecal Drug Delivery Systems

The drug is also used in the assessment of intrathecal drug-delivery systems, which are crucial for managing chronic pain and spasticity. A retrospective review from 2011 to 2012 demonstrated that Indium 111 DTPA scintigraphy is effective in identifying malfunctions in these systems, such as tracer restriction to the pump reservoir, extravasations, and failure of the tracer to migrate to the intrathecal space[5].

Safety and Efficacy

Clinical studies have shown that MPI Indium DTPA In 111 is generally safe, although it can cause adverse reactions such as skin reactions, vomiting, and in rare cases, septic meningitis and fatal outcomes[4].

Market Analysis

Market Status

MPI Indium DTPA In 111 is marketed by GE Healthcare Canada Inc. and has been available since 2019. The product is listed with a Drug Identification Number (DIN) of 02329093[2].

Market Demand

The demand for MPI Indium DTPA In 111 is driven by the increasing use of intrathecal drug-delivery systems for chronic pain and spasticity management. As the population ages and the prevalence of chronic pain conditions rises, the need for effective diagnostic tools to monitor these systems is expected to grow.

Competitive Landscape

The market for radiopharmaceuticals is competitive, with various products available for different diagnostic purposes. However, MPI Indium DTPA In 111 holds a unique position due to its specific applications in intrathecal drug delivery and infection detection.

Market Projections

Growth Potential

Given the expanding use of intrathecal drug-delivery systems and the ongoing need for accurate diagnostic tools, the market for MPI Indium DTPA In 111 is projected to grow. Advances in nuclear medicine and the increasing awareness of the benefits of this radiopharmaceutical are expected to drive demand.

Regulatory Environment

The regulatory environment plays a crucial role in the market projection. As long as MPI Indium DTPA In 111 remains approved and compliant with regulatory standards, it is likely to maintain its market presence. However, any changes in regulatory requirements or the introduction of new, more effective diagnostic tools could impact its market share.

Technological Advancements

Technological advancements in nuclear medicine and imaging techniques are expected to enhance the utility and safety of MPI Indium DTPA In 111. Improvements in dosimetry, imaging resolution, and patient safety protocols will likely contribute to its continued use and market growth.

Dosage and Administration

Intrathecal Use

MPI Indium DTPA In 111 is administered intrathecally, and extreme care must be taken to ensure aseptic conditions. The maximum recommended dose is 18.5 MBq (500 µCi) for an average patient (70 kg)[4].

Radiation Dosimetry

The drug's radiation dosimetry is carefully managed to minimize exposure. The total body dose is approximately 0.41 mGy (0.041 rad), with higher doses to specific areas such as the spinal cord surface and brain surface[4].

Safety Considerations

Pregnancy and Fertility

MPI Indium DTPA In 111 falls under Pregnancy Category C, meaning it should be given to pregnant women only if clearly needed. There is no data on its effects on fertility or fetal harm[4].

Geriatric Use

Clinical studies have not identified significant differences in responses between elderly and younger patients. However, dose selection for elderly patients should be cautious due to potential decreased hepatic, renal, or cardiac function[4].

Conclusion

MPI Indium DTPA In 111 is a valuable radiopharmaceutical with specific applications in the detection of infections and the assessment of intrathecal drug-delivery systems. Its market is expected to grow due to increasing demand for effective diagnostic tools in these areas. However, ongoing monitoring of safety, regulatory compliance, and technological advancements will be crucial for its continued success.

Key Takeaways

  • Clinical Applications: Effective in detecting infections like PCP and assessing intrathecal drug-delivery systems.
  • Market Status: Marketed by GE Healthcare Canada Inc. since 2019.
  • Market Demand: Driven by the increasing use of intrathecal drug-delivery systems.
  • Growth Potential: Expected to grow with advances in nuclear medicine and increasing awareness.
  • Regulatory Environment: Compliance with regulatory standards is crucial for market presence.
  • Technological Advancements: Improvements in dosimetry and imaging techniques will enhance its utility.
  • Safety Considerations: Careful administration and monitoring, especially in pregnant and elderly patients.

FAQs

Q1: What is MPI Indium DTPA In 111 used for?

MPI Indium DTPA In 111 is used for the detection of infections, such as Pneumocystis carinii pneumonia, and for assessing the function of intrathecal drug-delivery systems.

Q2: How is MPI Indium DTPA In 111 administered?

It is administered intrathecally, requiring strict aseptic conditions to avoid complications.

Q3: What are the potential side effects of MPI Indium DTPA In 111?

Potential side effects include skin reactions, vomiting, septic meningitis, and in rare cases, fatal outcomes.

Q4: Is MPI Indium DTPA In 111 safe for pregnant women?

It falls under Pregnancy Category C, meaning it should be given to pregnant women only if clearly needed, due to the lack of data on its effects on fertility or fetal harm.

Q5: How does the market for MPI Indium DTPA In 111 look in the future?

The market is projected to grow due to the increasing use of intrathecal drug-delivery systems and advances in nuclear medicine.

Sources

  1. PubMed: "111-indium-DTPA-IgG lung imaging in patients with pulmonary and extrapulmonary infections."
  2. Drug and Health Products Portal: "INDIUM DTPA IN 111."
  3. Journal of Nuclear Medicine: "MPI indium DTPA in 111."
  4. DailyMed: "INDIUM DTPA IN 111- indium in-111 pentetate disodium solution."
  5. PubMed: "Indium 111 diethylenetriamine pentaacetic acid scintigraphy in the evaluation of intrathecal drug-delivery systems."

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