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.

Clinical Trial Conditions for GALLIUM CITRATE GA 67

Condition Name

Condition Name for GALLIUM CITRATE GA 67
Intervention	Trials
Metastatic Prostate Adenocarcinoma	1
Metastatic Prostate Small Cell Carcinoma	1
Brain Tumors	1
Prostate Cancer	1

Condition MeSH

Condition MeSH for GALLIUM CITRATE GA 67
Intervention	Trials
Prostatic Neoplasms	3
Carcinoma	2
Lymphoma, Large B-Cell, Diffuse	1
Fibrosis	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
Michigan	1
Illinois	1
Texas	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
Zenith Epigenetics	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 Update, Market Analysis and Ex-Patent Projection

Last updated: July 28, 2026

Gallium citrate Ga 67 (commonly “Ga-67”) is an established radiopharmaceutical used in oncologic and inflammatory imaging. Public information on late-stage development and new pivotal trials is limited, and the market outlook is primarily driven by (1) aging and supply-side constraints for older radiopharma, (2) shifts to PET tracers and SPECT alternatives, and (3) country-level reimbursement and hospital imaging utilization rather than new entrant clinical programs.

Is Gallium citrate Ga 67 still in clinical trials and what is the latest study status?

Short answer: Ga-67 is not associated with a visible current wave of late-stage, registrational clinical trials in major registries. Usage remains driven by established indications and existing regulatory approvals in multiple jurisdictions.

What clinical trial registry signals exist for Ga-67 in recent years?

Featured outcomes for Ga-67 are typically observational, retrospective, or comparative imaging studies rather than randomized phase 3 programs. For business planning, this pattern usually indicates:

• No near-term “regulatory-switch” event (new indication or label expansion) is driving demand.
• Competitive displacement is more likely from tracer substitution (PET/CT) or from newer targeted agents.

What endpoints are typical in ongoing Ga-67 imaging studies?

When Ga-67 is studied, endpoints commonly include:

• Diagnostic sensitivity/specificity against reference standards (histopathology, clinical follow-up, or other imaging modalities).
• Lesion detection rates and image quality metrics.
• Radiation dose estimates and practical imaging workflow comparisons.

Does Ga-67 have new formulation or manufacturing clinical studies?

No broad, publicly visible late-stage clinical development pattern is present that would indicate a new version (reformulation, chelation system change, or automated kit workflow) moving toward approval.

How big is the Gallium citrate Ga 67 market and what drives demand?

Short answer: Ga-67 is a niche radiopharmaceutical with demand concentrated in hospitals and imaging centers that still perform SPECT imaging for approved uses. Market size is more sensitive to utilization and reimbursement than to innovation-led growth.

Where is Ga-67 demand concentrated?

Demand is usually concentrated in:

• Community and academic hospitals with nuclear medicine departments doing SPECT workflows.
• Health systems that maintain Ga-67 for specific approved diagnostic roles where PET access is limited or where payer coverage supports SPECT alternatives.

What use cases sustain Ga-67 utilization?

Ga-67 utilization is typically linked to:

• Oncology imaging for selected malignancies and staging/response contexts where it remains locally relevant.
• Inflammatory and infection imaging in specific clinical pathways where clinicians still use SPECT tracers.

What factors reduce Ga-67 demand?

Key downside drivers:

• Substitution toward PET tracers (better spatial resolution, faster workflows, and broader oncology coverage).
• Imaging strategy changes in oncology and infectious disease pathways.
• Consolidation of nuclear medicine services and fewer centers stocking older SPECT radiopharmaceuticals due to inventory burden.

What are the key competitive substitutes for Ga-67, and how do they affect pricing and volume?

Short answer: PET tracers and other SPECT radiopharmaceuticals reduce the “share of diagnostic workflow” allocated to Ga-67, compressing both volume and pricing power where reimbursement is competitive.

What substitute classes pressure Ga-67 utilization?

• PET radiopharmaceuticals used in oncology and infection workups (commonly FDG and targeted agents).
• Other SPECT tracers (depending on country-specific approvals and hospital protocols) for inflammation, infection, and selected oncologic indications.

How do substitution dynamics translate into market outcomes?

In radiopharma, displacement tends to show up as:

• Lower order frequency and reduced batch utilization.
• Higher forecasting risk for suppliers and radiopharm manufacturers, leading to less stable supply availability and higher per-unit costs.
• Contracting and tendering pressure at hospital procurement level, especially where PET capacity exists.

What does a 5-year market projection for Gallium citrate Ga 67 look like?

Short answer: The base case is flat-to-declining volume with periodic volatility from supply-chain and inventory management. Pricing may be stable or moderately up in some regions due to lower competition and constrained supply economics, but this is typically insufficient to offset usage declines driven by tracer substitution.

Projection framework used for radiopharma like Ga-67

A realistic projection for Ga-67 should be built from:

• Annual hospital imaging volume proxy (nuclear medicine utilization and SPECT exam mix).
• Substitution rate from Ga-67 toward PET or other tracers.
• Supply continuity and availability from eligible manufacturers.
• Reimbursement stability and guideline persistence.

Three-scenario view (directional)

• Base case: Gradual volume decline; modest pricing stability; overall market value slightly down or flat.
• Downside: Faster substitution plus tighter hospital procurement; bigger volume contraction; market value declines.
• Upside: Supply constraints for alternatives or payer reinforcement of SPECT pathways; volume stabilizes; modest value growth.

When does Gallium citrate Ga 67 lose exclusivity, and is there patent-driven demand risk?

Short answer: Ga-67 is generally treated as a legacy, non-blockbuster radiopharmaceutical. For most investors, the demand risk is less about patent cliffs and more about manufacturing access, distribution, and regulatory compliance for ongoing supply.

How to think about exclusivity for Ga-67

For older radiopharmaceuticals:

• The practical exclusivity question often shifts from “new formulations” to “commercial supply chain ownership” (facility licensing, process controls, radionuclide sourcing, GMP release testing).
• Even where method-of-manufacture or formulation-related patents existed historically, many are likely expired or not the binding constraint on current market access.

Key business implication

The largest market risks usually come from:

• Supplier attrition (facility closure, radionuclide procurement changes).
• Regulatory quality systems issues (deviations, inspection outcomes).
• Tender/pricing pressure rather than generic competition.

What patents protect Gallium citrate Ga 67, and how strong is the patent estate?

Short answer: A detailed patent estate map cannot be produced here because this request requires a jurisdiction-by-jurisdiction patent search and the prompt provides no patent publication set or claim lists to anchor the analysis. Without that, any “number of patents,” “expiration dates,” or “assignee strength” would be fabricated.

What is the Orange Book status of Gallium citrate Ga 67?

Short answer: Orange Book status cannot be produced in a complete, accurate way from the information provided in the prompt. Orange Book listings depend on exact product/label form, NDC matching, and listing dates.

What patent litigation affects Gallium citrate Ga 67 and generic entry?

Short answer: Patent litigation specifics cannot be provided without an identified litigation docket set tied to Ga-67 products and their Orange Book or equivalent listings. A litigation summary would otherwise risk being incomplete or inaccurate.

How does Ga-67 compare with other imaging agents in clinical utility and adoption?

Short answer: Ga-67 is a historically important SPECT imaging tracer, but adoption is increasingly constrained by the breadth and convenience of PET imaging and newer targeted radiopharmaceutical options.

Practical adoption factors

• SPECT workflow and reconstruction constraints versus PET resolution.
• Imaging pathway selection by specialty guidelines and payer coverage.
• Institutional familiarity and long-established imaging protocols.

Clinical utility positioning

For business decisions, Ga-67’s practical position is “persistent niche use,” not a broad expansion opportunity driven by new clinical trials.

What manufacturing and supply constraints shape market availability for Ga-67?

Short answer: Supply stability is a central risk driver for radiopharmaceuticals. For legacy tracers, the bottleneck is often manufacturing and radionuclide sourcing continuity.

Key supply-chain dependencies

• Radionuclide availability and logistics.
• Radiopharm GMP release testing capacity.
• Shelf-life, shipping conditions, and cold-chain logistics.
• Site-specific licensing and inspection outcomes.

How supply constraints change pricing

When supply tightens:

• Hospitals may accept higher per-dose costs to maintain continuity.
• Distributors and manufacturers may impose allocation or higher freight/handling markups.
• Tendering outcomes can swing based on availability rather than pure unit economics.

What commercial strategy best fits a Ga-67 market projection?

Short answer: Commercial plans should treat Ga-67 as a supply-reliability and reimbursement-access product, with growth tied to procurement retention rather than pipeline-led expansion.

High-impact levers

• Contracting with hospital networks that still run Ga-67 SPECT pathways.
• Ensuring uninterrupted manufacturing and distribution capacity.
• Mapping payer coverage and local guideline persistence for Ga-67 uses.
• Maintaining competitive lead times and fill-rate performance.

Key Takeaways

• Ga-67 is an established radiopharmaceutical with limited visible late-stage clinical expansion; market dynamics are mostly utilization and substitution-driven.
• Projection is best framed as flat-to-declining volume with value stability depending on supply conditions and reimbursement.
• Patent cliff risk is not the primary driver; manufacturing continuity, regulatory compliance, and procurement economics are.
• Competitive pressure is predominantly tracer substitution (PET and other imaging options) rather than generic entry competition.

FAQs

1. Why do hospitals still use Ga-67 SPECT instead of PET for some indications?
2. What supply disruptions most affect Ga-67 availability and hospital ordering behavior?
3. How do reimbursement policies by country influence Ga-67 volume trends?
4. What are the most common diagnostic workflow substitutions that reduce Ga-67 demand?
5. What commercial KPIs predict Ga-67 contract retention in hospital procurement cycles?

References

1. U.S. Food and Drug Administration (FDA). Drugs@FDA.
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
3. ClinicalTrials.gov. Gallium citrate Ga 67 search results.
4. European Medicines Agency (EMA). Public assessment and product information for gallium citrate products.