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
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.
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.
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.

Clinical Trial Conditions for GALLIUM CITRATE GA 67

Condition Name

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

Condition MeSH

Condition MeSH for GALLIUM CITRATE GA 67
Intervention	Trials
Prostatic Neoplasms	3
Carcinoma	2
Fibrosis	1
Brain Neoplasms	1

Clinical Trial Locations for GALLIUM CITRATE GA 67

Trials by Country

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−

Trials by Country for GALLIUM CITRATE GA 67
Location	Trials
United States	15
France	1

Trials by US State

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−

Trials by US State for GALLIUM CITRATE GA 67
Location	Trials
California	3
New Jersey	2
Texas	1
Oklahoma	1
Nebraska	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
M.D. Anderson Cancer Center	1

Sponsor Type

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

Gallium Citrate Ga 67: Clinical Trials, Market Analysis, and Projections

Introduction to Gallium Citrate Ga 67

Gallium Citrate Ga 67 is a radiopharmaceutical used primarily in nuclear medicine for diagnostic imaging. It is particularly useful in detecting and staging various malignancies and inflammatory processes. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Use and Mechanism

Gallium Citrate Ga 67 concentrates in viable primary and metastatic tumors, as well as in focal sites of infection. The mechanism of this concentration involves the accumulation of gallium in lysosomes and its binding to a soluble intracellular protein[1][5].

Diagnostic Applications

• Oncology: Gallium Citrate Ga 67 is useful in demonstrating the presence and extent of Hodgkin's disease, lymphomas, and bronchogenic carcinoma[1][5].
• Inflammatory Processes: It is effective in localizing inflammatory lesions, especially when routine clinical and radiologic studies fail to identify the abnormality[4].

Clinical Trials and Efficacy

Clinical studies have shown the efficacy of Gallium Citrate Ga 67 in various diagnostic scenarios:

• Cancer Detection: Studies have confirmed that Gallium Citrate Ga 67 can accurately detect and stage cancers, particularly those with high metabolic activity[1][5].
• Inflammatory Processes: In patients with suspected inflammatory processes, Gallium Citrate Ga 67 imaging has been shown to be accurate in localizing the abnormality, with confirmation through aspiration, surgery, or autopsy in many cases[4].

Safety and Adverse Reactions

Clinical trials have generally shown that Gallium Citrate Ga 67 is safe, with rare adverse reactions such as severe itching, erythema, rash, and nausea reported in a small number of patients[1].

Market Analysis

Current Market

The market for gallium radiopharmaceuticals, including Gallium Citrate Ga 67, is part of a broader nuclear medicine market. Here are some key points:

• Gallium-68 Market: While Gallium-68 is a different isotope, the overall trend in gallium radiopharmaceuticals is indicative of the growing demand. The Gallium-68 market was valued at approximately $100 million in 2020 and is projected to expand at a CAGR of about 8% from 2021 to 2031[2].
• Key Players: Companies such as Siemens Healthineers AG, ITM Isotopen Technologien München AG, and Advanced Accelerator Applications (a Novartis AG Company) are major players in the gallium radiopharmaceutical market[2].

Market Segmentation

The market for Gallium Citrate Ga 67 can be segmented by application and region:

• Applications: Oncology, cardiology, neurology, and other diagnostic applications. Oncology accounts for a major share of the market[2].
• Regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. Each region has its own growth trajectory and market dynamics[2].

Market Projections

Growth Drivers

• Increasing Prevalence of Oncology: The rising incidence of cancers and the need for accurate diagnostic tools are driving the demand for gallium radiopharmaceuticals[2].
• Advancements in Nuclear Medicine: Improvements in PET technology and the development of new gallium-based agents with better targeting abilities are expected to enhance the market[3].

Regional Outlook

• North America and Europe: These regions are expected to continue as major markets due to advanced healthcare infrastructure and high awareness about the benefits of nuclear medicine[2].
• Asia Pacific: This region is anticipated to show significant growth due to increasing healthcare spending and the adoption of advanced diagnostic technologies[2].

Future Developments and Innovations

Enhancing Diagnostic Capabilities

Research is ongoing to create new gallium-based agents with improved targeting abilities and reduced background uptake. This includes the development of novel ligands and molecular structures that can bind more selectively to tumor cells or sites of infection and inflammation[3].

Advances in PET Technology

Improvements in PET detectors and image processing algorithms are expected to broaden the clinical applications of gallium radiopharmaceuticals, providing clearer and more detailed images. This will aid in early detection and precise localization of diseases[3].

Key Takeaways

• Clinical Efficacy: Gallium Citrate Ga 67 is effective in detecting and staging various cancers and inflammatory processes.
• Market Growth: The market for gallium radiopharmaceuticals is expected to grow at a CAGR of about 8% from 2021 to 2031, driven by increasing oncology prevalence and advancements in nuclear medicine.
• Regional Dynamics: North America, Europe, and Asia Pacific are key regions with significant growth potential.
• Future Innovations: Ongoing research aims to enhance the diagnostic capabilities of gallium radiopharmaceuticals through better targeting and improved PET technology.

FAQs

What is Gallium Citrate Ga 67 used for?

Gallium Citrate Ga 67 is used primarily for diagnostic imaging to detect and stage various malignancies such as Hodgkin's disease, lymphomas, and bronchogenic carcinoma, as well as to localize inflammatory processes.

How is Gallium Citrate Ga 67 administered?

Gallium Citrate Ga 67 is administered intravenously, with a recommended adult dose of 74-185 MBq (2-5 mCi)[1][5].

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

Common side effects are rare but can include severe itching, erythema, rash, and nausea[1].

What is the market outlook for gallium radiopharmaceuticals?

The market for gallium radiopharmaceuticals is projected to expand at a CAGR of about 8% from 2021 to 2031, driven by the increasing prevalence of oncology and advancements in nuclear medicine[2].

What are the key regions for the gallium radiopharmaceutical market?

Key regions include North America, Europe, Asia Pacific, Latin America, and Middle East & Africa, with North America and Europe being major markets and Asia Pacific showing significant growth potential[2].

Sources

1. FDA Label: Gallium Citrate Ga 67 Injection - accessdata.fda.gov
2. Transparency Market Research: Gallium-68 Market Survey Report 2031 - transparencymarketresearch.com
3. OpenMedScience: Gallium Radiopharmaceuticals in Medical Imaging - openmedscience.com
4. JAMA Network: Gallium Citrate Ga 67 Imaging in Patients With Suspected Inflammatory Processes - jamanetwork.com
5. Drugs.com: Gallium Citrate Ga 67: Package Insert / Prescribing Info - drugs.com