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Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR GALLIUM CITRATE GA-67


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All Clinical Trials for Gallium Citrate Ga-67

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00477503 ↗ Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA Terminated M.D. Anderson Cancer Center Phase 1 2007-05-01 - Primary Objective will be to evaluate the use of Ga-67 citrate as an alternative radiopharmaceutical for CSF imaging. - Secondary Objective will be to evaluate the biodistribution, pharmacokinetics and radiation dosimetry of In 111 DTPA and gallium-67 after intrathecal injection during remission of leptomeningeal metastasis (LM) and during LM occurrence, remission and recurrence.
NCT02391025 ↗ Gallium-68 Citrate PET Used in Prostate Cancer Recruiting United States Department of Defense Early Phase 1 2015-05-28 This is a single center cross-sectional imaging study investigating the use of gallium-68 citrate PET in patients with metastatic castration-resistant prostate cancer who are planning to undergo a metastatic tumor biopsy on protocol NCT02432001 (CC#125519). The study population will consist of patients with metastatic castration-resistant prostate cancer who are undergoing a metastatic tumor biopsy as part of clinical protocol NCT02432001 (CC#125519), with evidence of resistance to androgen signaling inhibition. The study will involve gallium-68 PET scan obtained at single time point, followed by radiographically-guided metastatic tumor biopsy within 14 days of PET scan.
NCT02391025 ↗ Gallium-68 Citrate PET Used in Prostate Cancer Recruiting Rahul Aggarwal Early Phase 1 2015-05-28 This is a single center cross-sectional imaging study investigating the use of gallium-68 citrate PET in patients with metastatic castration-resistant prostate cancer who are planning to undergo a metastatic tumor biopsy on protocol NCT02432001 (CC#125519). The study population will consist of patients with metastatic castration-resistant prostate cancer who are undergoing a metastatic tumor biopsy as part of clinical protocol NCT02432001 (CC#125519), with evidence of resistance to androgen signaling inhibition. The study will involve gallium-68 PET scan obtained at single time point, followed by radiographically-guided metastatic tumor biopsy within 14 days of PET scan.
NCT02494921 ↗ LEE011 (Ribociclib) in Combination With Docetaxel Plus Prednisone in mCRPC Completed Novartis Phase 1/Phase 2 2015-11-20 This is a Phase Ib/II open label clinical trial in patients with metastatic castration resistant prostate cancer. The objective of the phase Ib portion of the study is to establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of docetaxel (75 mg/m2 IV q21 days) and prednisone (5mg orally BID) in combination with ribociclib in escalating oral daily doses in patients with metastatic castrate resistant prostate cancer (mCRPC) with prior resistance to abiraterone and/or enzalutamide who have not undergone prior chemotherapy for metastatic disease. Up to three cohorts will be enrolled to determine the MTD and DLT profile of this combination during Phase 1b. Dose escalation will follow the standard 3+3 design. The dosing schedule is being chosen to allow patients to be exposed to the most efficacious dosing schedule of docetaxel (75 mg/m2 every 3 weeks). If there is excess toxicity observed with the treatment combination at the first dose level (dose level I), an alternative dosing schema may be pursued with weekly docetaxel treatment (35 mg/m2 weekly), which has demonstrated activity in mCRPC and decreased risk of cytopenias compared with every 3 week dosing schedule. The Phase II portion (N = 29) of the study is a single arm, two stage, open-label study of ribociclib (dosed at the RP2D) in combination with docetaxel and prednisone to determine the efficacy and further define the safety of the treatment combination. Patients will be treated with the combination of ribociclib plus docetaxel + prednisone for up to 9 cycles. If there is no evidence of radiographic or clinical disease progression after 9 cycles of protocol therapy, patients may continue on single agent maintenance ribociclib until the time of disease progression. Patients will have the option of starting maintenance ribociclib after 6 cycles of docetaxel if stable disease or better on re-staging scans. The dose of ribociclib used during maintenance will be the same dose as that immediately preceding cessation of docetaxel treatment.
NCT02494921 ↗ LEE011 (Ribociclib) in Combination With Docetaxel Plus Prednisone in mCRPC Completed Rahul Aggarwal Phase 1/Phase 2 2015-11-20 This is a Phase Ib/II open label clinical trial in patients with metastatic castration resistant prostate cancer. The objective of the phase Ib portion of the study is to establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of docetaxel (75 mg/m2 IV q21 days) and prednisone (5mg orally BID) in combination with ribociclib in escalating oral daily doses in patients with metastatic castrate resistant prostate cancer (mCRPC) with prior resistance to abiraterone and/or enzalutamide who have not undergone prior chemotherapy for metastatic disease. Up to three cohorts will be enrolled to determine the MTD and DLT profile of this combination during Phase 1b. Dose escalation will follow the standard 3+3 design. The dosing schedule is being chosen to allow patients to be exposed to the most efficacious dosing schedule of docetaxel (75 mg/m2 every 3 weeks). If there is excess toxicity observed with the treatment combination at the first dose level (dose level I), an alternative dosing schema may be pursued with weekly docetaxel treatment (35 mg/m2 weekly), which has demonstrated activity in mCRPC and decreased risk of cytopenias compared with every 3 week dosing schedule. The Phase II portion (N = 29) of the study is a single arm, two stage, open-label study of ribociclib (dosed at the RP2D) in combination with docetaxel and prednisone to determine the efficacy and further define the safety of the treatment combination. Patients will be treated with the combination of ribociclib plus docetaxel + prednisone for up to 9 cycles. If there is no evidence of radiographic or clinical disease progression after 9 cycles of protocol therapy, patients may continue on single agent maintenance ribociclib until the time of disease progression. Patients will have the option of starting maintenance ribociclib after 6 cycles of docetaxel if stable disease or better on re-staging scans. The dose of ribociclib used during maintenance will be the same dose as that immediately preceding cessation of docetaxel treatment.
NCT02776891 ↗ A Feasibility Study of Gallium-68 Citrate PET to Detect Aberrant MYC Proto-Oncogene, BHLH Transcription Factor (MYC) Protein Expression in Diffuse Large B-Cell Lymphoma Withdrawn University of California, San Francisco Phase 2 2016-06-13 This is a single center imaging study investigating the use of PET with 68Ga-citrate in patients with DLBCL or BCLU.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Gallium Citrate Ga-67

Condition Name

Condition Name for Gallium Citrate Ga-67
Intervention Trials
Lymphoma, Large B-Cell, Diffuse 1
Metastatic Prostate Adenocarcinoma 1
Metastatic Prostate Small Cell Carcinoma 1
Brain Tumors 1
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Condition MeSH

Condition MeSH for Gallium Citrate Ga-67
Intervention Trials
Prostatic Neoplasms 3
Carcinoma 2
Cystic Fibrosis 1
Endocarditis, Bacterial 1
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Clinical Trial Locations for Gallium Citrate Ga-67

Trials by Country

Trials by Country for Gallium Citrate Ga-67
Location Trials
United States 15
France 1
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Trials by US State

Trials by US State for Gallium Citrate Ga-67
Location Trials
California 3
New Jersey 2
Oklahoma 1
Nebraska 1
Maine 1
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Clinical Trial Progress for Gallium Citrate Ga-67

Clinical Trial Phase

Clinical Trial Phase for Gallium Citrate Ga-67
Clinical Trial Phase Trials
Phase 2 5
Phase 1/Phase 2 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Gallium Citrate Ga-67
Clinical Trial Phase Trials
Recruiting 3
Terminated 2
Completed 1
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Clinical Trial Sponsors for Gallium Citrate Ga-67

Sponsor Name

Sponsor Name for Gallium Citrate Ga-67
Sponsor Trials
Rahul Aggarwal 3
Rutgers, The State University of New Jersey 2
United States Department of Defense 1
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Sponsor Type

Sponsor Type for Gallium Citrate Ga-67
Sponsor Trials
Other 9
Industry 4
U.S. Fed 2
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Gallium Citrate Ga-67: Clinical Trials, Market Analysis, and Projections

Clinical Trials Update

Gallium Citrate Ga-67, a radiopharmaceutical, has been involved in various clinical trials to evaluate its efficacy and safety in different medical applications.

Notable Clinical Trials

  • Phase 1 Study on Nuclear Imaging of Human CSF Flow: This trial, conducted by The University of Texas MD Anderson Cancer Center, aimed to evaluate the use of Ga-67 citrate as an alternative radiopharmaceutical for cerebrospinal fluid (CSF) imaging. The study also assessed the biodistribution, pharmacokinetics, and radiation dosimetry of In-111 DTPA and gallium-67 in patients with leptomeningeal metastasis. Although the trial was terminated, it provided valuable insights into the potential of Ga-67 citrate in neuroimaging[1].

Market Analysis

Current Market Status

The market for gallium radiopharmaceuticals, including Ga-67, is closely tied to the broader nuclear medicine market. Here are some key points:

  • Gallium-68 Market Influence: While Ga-68 is gaining prominence, Ga-67 continues to be extensively used for the clinical diagnosis of specific types of neoplasms such as Hodgkin’s disease, lung cancer, non-Hodgkin’s lymphoma, malignant melanoma, and leukemia. The rise in the prevalence of tumors and cancer has driven the demand for both Ga-67 and Ga-68[2].

  • End-User Segmentation: The market for gallium radiopharmaceuticals is segmented by end-users, including hospitals, diagnostic centers, and other healthcare facilities. Hospitals and diagnostic centers are the primary users of these radiopharmaceuticals[2].

Key Applications

  • Oncology: Ga-67 citrate is particularly useful in oncology for detecting and staging various cancers. It accumulates in areas with high metabolic activity, such as tumor sites, making it valuable for diagnosing malignancies like Hodgkin's disease, lymphomas, and bronchogenic carcinoma[4][5].

  • Infection and Inflammation: Besides cancer, Ga-67 citrate also accumulates in sites of infection and inflammation, making it a versatile tool in clinical diagnostics[4].

Market Projections

Growth Drivers

  • Increasing Prevalence of Cancer: The rising incidence of cancer globally is a significant driver for the demand of gallium radiopharmaceuticals, including Ga-67. As cancer diagnosis and treatment become more sophisticated, the need for accurate and reliable imaging agents like Ga-67 citrate is expected to increase[2].

  • Advancements in Nuclear Medicine: Ongoing research and advancements in nuclear medicine, particularly in PET and SPECT imaging, are enhancing the diagnostic capabilities of gallium radiopharmaceuticals. This includes the development of new gallium-based agents with improved targeting abilities and reduced background uptake[3].

Market Size and CAGR

  • The gallium-68 market, which is closely related to the Ga-67 market, was valued at approximately US$ 100 million in 2020 and is projected to expand at a CAGR of about 8% from 2021 to 2031, reaching US$ 200 million by 2031. While specific figures for Ga-67 are not provided, its continued use and the growing demand for gallium radiopharmaceuticals suggest a stable and potentially growing market for Ga-67 as well[2].

Regional Analysis

  • The market for gallium radiopharmaceuticals is analyzed regionally, with significant growth expected in regions like Asia Pacific, Latin America, and the Middle East & Africa. These regions are seeing increased investment in healthcare infrastructure and a growing awareness of the benefits of nuclear medicine[2].

Future Outlook

Advancements in Radiopharmaceutical Chemistry

  • Research is focused on creating new gallium-based agents with improved targeting abilities and reduced background uptake. Innovations in radiopharmaceutical chemistry, such as novel ligands and molecular structures, are expected to enhance the specificity and clarity of gallium scans, thereby improving diagnostic accuracy[3].

Technological Advancements

  • Advancements in PET technology, including better detectors and image processing algorithms, are likely to broaden the clinical applications of gallium radiopharmaceuticals. Enhanced imaging capabilities could provide clearer, more detailed images, aiding in early detection and precise localization of diseases[3].

Key Takeaways

  • Clinical Trials: Ga-67 citrate has been involved in clinical trials to evaluate its use in CSF imaging and other applications.
  • Market Analysis: The market for gallium radiopharmaceuticals is driven by the increasing prevalence of cancer and advancements in nuclear medicine.
  • Projections: The market is expected to grow, with a CAGR of about 8% for related gallium-68 market, indicating a stable and potentially growing market for Ga-67.
  • Future Outlook: Ongoing research in radiopharmaceutical chemistry and technological advancements in PET imaging are expected to enhance the diagnostic capabilities of Ga-67 citrate.

FAQs

What is Gallium Citrate Ga-67 used for?

Gallium Citrate Ga-67 is used primarily for the clinical diagnosis of specific types of neoplasms such as Hodgkin’s disease, lymphomas, and bronchogenic carcinoma, as well as for detecting sites of infection and inflammation[4][5].

How is Gallium Citrate Ga-67 administered?

Gallium Citrate Ga-67 is administered intravenously, with a recommended adult dose of 2-5 millicuries (74-185 MBq)[4][5].

What are the side effects of Gallium Citrate Ga-67?

Common side effects include severe itching, erythema, rash, hypersensitivity reactions, skin rash, and nausea. However, these are rare occurrences[4].

How does Gallium Citrate Ga-67 accumulate in the body?

Gallium Citrate Ga-67 accumulates in areas with high metabolic activity, such as tumor sites, and in sites of infection and inflammation. It is also found in the renal cortex, bone, lymph nodes, liver, and spleen after administration[4].

Is Gallium Citrate Ga-67 safe for pregnant or nursing women?

Gallium Citrate Ga-67 should be used in pregnant women only when clearly needed, and it should not be used in nursing mothers due to its accumulation in breast milk[5].

Sources

  1. Synapse: Clinical Trials associated with Gallium Citrate Ga-67.
  2. Transparency Market Research: Gallium-68 Market Survey Report 2031.
  3. OpenMedScience: Gallium Radiopharmaceuticals in Medical Imaging.
  4. Lantheus: Gallium-67 Injection.
  5. Journal of Nuclear Medicine: Gallium Citrate Ga67.

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