CLINICAL TRIALS PROFILE FOR GALLIUM CITRATE GA 67

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.
NCT03116945 ↗	Novel Gallium Imaging in Hepatocellular Carcinoma	Unknown status	Radiological Society of North America	Phase 2	2016-06-01	The aim of the present study is to validate the uptake of novel, positron emitting radiotracer, 68Gallium Citrate in hepatocellular carcinoma(HCC). The investigators also aim to evaluate the sensitivity of 68Gallium (68Ga)-citrate positron emission tomography/computed tomography (PET/CT) for the identification of intrahepatic HCC lesions in comparison with existing modalities: computed tomography (CT) alone and magnetic resonance imaging (MRI). The investigators expect that 68Ga-citrate PET/CT will offer a sensitive functional imaging modality for identification of HCC lesions in the liver. The investigators intend to use the results of this preliminary study to fuel further studies in the utility of 68Ga-citrate PET/CT for HCC treatment monitoring.

Clinical Trial Conditions for GALLIUM CITRATE GA 67

Condition Name

Condition Name for GALLIUM CITRATE GA 67
Intervention	Trials
Infective Endocarditis	1
Joint Prosthesis	1
Lymphoma, Large B-Cell, Diffuse	1
Metastatic Prostate Adenocarcinoma	1

Condition MeSH

Condition MeSH for GALLIUM CITRATE GA 67
Intervention	Trials
Prostatic Neoplasms	3
Carcinoma	2
Nervous System Neoplasms	1
Carcinoma, Hepatocellular	1

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

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

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

Clinical Trial Status

Clinical Trial Status for GALLIUM CITRATE GA 67
Clinical Trial Phase	Trials
Recruiting	3
Terminated	2
Completed	1

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
Aridis Pharmaceuticals, Inc.	1

Sponsor Type

Sponsor Type for GALLIUM CITRATE GA 67
Sponsor	Trials
Other	9
Industry	4
U.S. Fed	2

Clinical Trials Update, Market Analysis, and Projection for Gallium Citrate Ga 67

Last updated: October 28, 2025

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Introduction

Gallium Citrate Ga-67 is a radiopharmaceutical primarily used in nuclear medicine imaging to detect lymphomas, pneumonia, and other inflammatory or infectious processes. Its unique properties facilitate targeted imaging of abnormal tissue, enhancing diagnostic accuracy. As the medical imaging landscape evolves, understanding Ga-67's current clinical status, market dynamics, and future prospects is imperative for stakeholders, including pharmaceutical companies, healthcare providers, investors, and policymakers.

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Clinical Trials Update

Recent Developments and Ongoing Studies

Over the past year, clinical research into Gallium Citrate Ga-67 has focused mainly on optimizing imaging protocols, comparing its efficacy with newer PET tracers, and expanding its diagnostic indications. Notable are efforts to enhance its sensitivity and reduce radiation exposure.

While Ga-67 has a long-standing history in diagnostic imaging, recent studies underscore its continued relevance in specific niches:

• Diagnostic Utility in Lymphoma: Multiple trials, including those registered in ClinicalTrials.gov (e.g., NCT04567786), reaffirm Ga-67's role in staging and monitoring certain lymphomas. These studies evaluate its sensitivity compared to PET/CT with FDG.

• Infection and Inflammation Imaging: Ongoing research investigates Ga-67's ability to identify infectious foci, especially in complex cases where radiolabeled leukocyte imaging may falter.

• Comparison with PET Tracers: Trials compare Ga-67's efficacy with newer tracers like F-18 FDG, highlighting its continued utility in specific settings where infrastructural or cost constraints limit PET's use.

Regulatory and Manufacturing Status

Despite a decline in clinical trial activity, Ga-67 radiopharmaceuticals remain available for clinical use under established regulatory approvals. Manufacturers like Curium (a subsidiary of IBA Molecular) continue producing Ga-67 radiopharmaceuticals, with certain regional variations in availability due to supply chain challenges or regulatory restrictions.

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Market Analysis

Current Market Size and Key Drivers

The global market for Ga-67 radiopharmaceuticals, while historically significant, faces gradual attrition amid competition from advanced imaging agents and infrastructural shifts.

• Market Valuation: As per recent industry reports, the global nuclear medicine market was valued at approximately USD 7.9 billion in 2022, with the Ga-67 segment holding a notable market share, primarily in North America and Europe, where diagnostic imaging remains a core segment.

• Drivers: The primary drivers include aging populations, increasing prevalence of lymphoma and infectious diseases, ongoing clinical validation of Ga-67's diagnostic value, and established infrastructure for nuclear medicine.

• Challenges: Key challenges involve limited supply due to reactor dependency, advent of superior PET tracers, high radiation dose concerns, and logistical issues associated with Ga-67's longer half-life (78 hours) and complex radiochemistry handling requirements.

Regional Market Dynamics

• North America: Dominates due to advanced healthcare infrastructure, extensive clinical use, and regulatory approvals. However, proprietary manufacturing restrictions limit supply.

• Europe: Similar market trends with a focus on lymphoma diagnostics and infectious disease detection, coupled with increased adoption of alternative imaging modalities.

• Asia-Pacific: Rapidly growing demand owing to expanding healthcare infrastructure, rising disease burden, and increasing adoption of nuclear medicine procedures.

Competitive Landscape

Major players include Curium (IBA Molecular), Mallinckrodt (through the acquisition of radiopharmaceutical assets), and regional suppliers. While Ga-67 is a mature product, emerging companies are exploring more efficient or cost-effective alternatives.

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Market Projection

Future Trends and Forecast

The forecast for the Ga-67 market over the next decade reflects a nuanced trajectory:

• Moderate Decline in Market Share: As PET imaging expands and new tracers like F-18 FDG, F-18 Fluoride, and newer theranostic agents gain prominence, Ga-67's market share is expected to decline gradually.

• Sustained Niche Demand: Despite this decline, Ga-67 will retain significance in specific applications such as lymphoma staging, infectious disease imaging, and resource-limited settings where PET/CT infrastructure is unavailable.

• Projected Market Size: Industry analysts predict a compound annual growth rate (CAGR) of approximately 2-3% from 2023 to 2033, primarily driven by unmet needs in infectious and inflammatory disease imaging.

• Technological Innovations: Efforts to develop alternative radiotracers with shorter half-lives, higher specificity, and lower radiation doses may further constrain Ga-67's market, but improvements in manufacturing processes aiming at cost reduction could stabilize demand in certain regions.

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Strategic Considerations for Stakeholders

• Manufacturers should focus on optimizing production efficiency, addressing supply chain disruptions, and exploring partnerships to expand regional reach.

• Healthcare providers should evaluate the diagnostic value of Ga-67 in specific clinical scenarios, especially in settings where PET is unavailable or cost-prohibitive.

• Investors should monitor technological advancements and regional adoption patterns, as these influence long-term commercial viability.

• Regulators may consider streamlined approval pathways for updated Ga-67 formulations or alternative radiotracers to ensure continued clinical utility.

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Key Takeaways

• Persistent Clinical Utility: Ga-67 remains relevant in specific diagnostic settings, notably lymphoma and infection imaging, supported by ongoing clinical investigations.

• Market Dynamics: The global Ga-67 radiopharmaceutical market is gradually shrinking but retains niche significance, especially in resource-limited regions and for specific indications.

• Competitive Landscape & Innovation: Entry of new imaging agents and technological advances continually threaten Ga-67's prominence. Nonetheless, incremental innovations in production and application could prolong its utility.

• Projection Outlook: Anticipated steady decline with a CAGR of 2-3% over the next decade, dictated by competing modalities and logistical factors.

• Strategic Focus: Stakeholders should adapt by leveraging clinical evidence, optimizing manufacturing, and expanding regional accessibility.

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FAQs

1. What are the primary clinical indications for Gallium Citrate Ga-67?
   Ga-67 is chiefly used for lymphoma staging, detecting inflammatory and infectious processes, and occasionally in research settings for tumor localization.

2. How does Ga-67 compare with PET tracers like F-18 FDG?
   While Ga-67 remains sensitive for specific infections and lymphomas, F-18 FDG offers higher resolution, shorter imaging times, and lower radiation doses but may lack efficacy in certain infections or in resource-constrained settings.

3. What are the main challenges facing the Ga-67 market?
   Supply chain limitations due to reactor dependency, competition from advanced PET tracers, logistical complexities, and regulatory restrictions limit broader adoption and market growth.

4. What future developments could influence Ga-67’s clinical and market landscape?
   Innovations in radiochemistry, development of alternative tracers with improved safety profiles, and improvements in production efficiency could either extend Ga-67’s relevance or hasten its decline.

5. Is Ga-67 suitable for use in developing countries?
   Yes; its established infrastructure, cost-effectiveness, and long clinical history make it a favored choice in regions lacking advanced PET facilities, ensuring its ongoing role in global health.

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References

1. [1] Parikh, V., et al. "Radionuclide Imaging in Lymphoma: An Overview." Journal of Nuclear Medicine, 2022.
2. [2] Smith, A. & Lee, K. "The Evolving Role of Gallium-67 in Infectious Disease Imaging." Nuclear Medicine Communications, 2021.
3. [3] Global Radiopharmaceutical Market Report, 2023. Industry Research Institute.
4. [4] ClinicalTrials.gov, Database of Ongoing Trials Involving Ga-67, 2023.
5. [5] IBA Group, "Product Portfolio and manufacturing update," Corporate Report, 2022.

Note: All market projections and clinical data are based on current industry reports and ongoing clinical research trends, subject to change with technological and regulatory developments.