CLINICAL TRIALS PROFILE FOR GALLIUM GA-68 GOZETOTIDE

All Clinical Trials for gallium ga-68 gozetotide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04762888 ↗	68Ga-PSMA-Dual-Contrast PET/MRI or PET/CT for Early Detection of Liver Cancer	Recruiting	National Cancer Institute (NCI)	Phase 2	2021-02-24	This phase II trial studies how well 68Ga-PSMA PET/MRI or PET/CT works in early detection of liver cancer. 68Gallium-PSMA is a radioactive tracer designed to circulate through the body and attach itself to the prostate- specific membrane antigen (PSMA) protein on liver cancer cells. Magnetic resonance imaging (MRI) is a scan that uses magnetic and radio waves to produce detailed structural information of the organs, tissues, and structures within the body. Positron emission tomography (PET) is an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (tracer) to show this activity. Computed tomography (CT) scan uses X-rays to create images of the bones and internal organs within your body. Combining a PET scan with an MRI or CT scan may help make the images easier to interpret. This trial may help determine if 68Ga- PSMA PET/MRI or PET/CT can improve upon the diagnosis and management of liver cancer in the future.
NCT04762888 ↗	68Ga-PSMA-Dual-Contrast PET/MRI or PET/CT for Early Detection of Liver Cancer	Recruiting	Mayo Clinic	Phase 2	2021-02-24	This phase II trial studies how well 68Ga-PSMA PET/MRI or PET/CT works in early detection of liver cancer. 68Gallium-PSMA is a radioactive tracer designed to circulate through the body and attach itself to the prostate- specific membrane antigen (PSMA) protein on liver cancer cells. Magnetic resonance imaging (MRI) is a scan that uses magnetic and radio waves to produce detailed structural information of the organs, tissues, and structures within the body. Positron emission tomography (PET) is an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (tracer) to show this activity. Computed tomography (CT) scan uses X-rays to create images of the bones and internal organs within your body. Combining a PET scan with an MRI or CT scan may help make the images easier to interpret. This trial may help determine if 68Ga- PSMA PET/MRI or PET/CT can improve upon the diagnosis and management of liver cancer in the future.
NCT05113537 ↗	Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer	Not yet recruiting	Eli Lilly and Company	Phase 1/Phase 2	2021-12-31	This phase I/II trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abemaciclib is in a class of medications called kinase inhibitors. It is highly selective inhibitors of cyclin-dependent kinase 4 and 6, which are proteins involved in cell differentiation and growth. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. Radioligand therapy uses a small molecule (in this case 177Lu-PSMA-617), which carries a radioactive component to destroys tumor cells. When 177Lu-PSMA-617 is injected into the body, it attaches to the prostate-specific membrane antigen (PSMA) receptor found on tumor cells. After 177Lu-PSMA-617 attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving abemaciclib before 177Lu-PSMA-617 may help 177Lu-PSMA-617 kill more tumor cells.
NCT05113537 ↗	Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer	Not yet recruiting	Prostate Cancer Foundation	Phase 1/Phase 2	2021-12-31	This phase I/II trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abemaciclib is in a class of medications called kinase inhibitors. It is highly selective inhibitors of cyclin-dependent kinase 4 and 6, which are proteins involved in cell differentiation and growth. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. Radioligand therapy uses a small molecule (in this case 177Lu-PSMA-617), which carries a radioactive component to destroys tumor cells. When 177Lu-PSMA-617 is injected into the body, it attaches to the prostate-specific membrane antigen (PSMA) receptor found on tumor cells. After 177Lu-PSMA-617 attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving abemaciclib before 177Lu-PSMA-617 may help 177Lu-PSMA-617 kill more tumor cells.
NCT05113537 ↗	Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer	Not yet recruiting	University of California, San Francisco	Phase 1/Phase 2	2021-12-31	This phase I/II trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abemaciclib is in a class of medications called kinase inhibitors. It is highly selective inhibitors of cyclin-dependent kinase 4 and 6, which are proteins involved in cell differentiation and growth. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. Radioligand therapy uses a small molecule (in this case 177Lu-PSMA-617), which carries a radioactive component to destroys tumor cells. When 177Lu-PSMA-617 is injected into the body, it attaches to the prostate-specific membrane antigen (PSMA) receptor found on tumor cells. After 177Lu-PSMA-617 attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving abemaciclib before 177Lu-PSMA-617 may help 177Lu-PSMA-617 kill more tumor cells.
NCT05547386 ↗	68Ga-PSMA-11 PET/CT Screening Prior to 177Lu-PSMA-617 Therapy for Patients With Metastatic Castrate Resistant Prostate Cancer	Enrolling by invitation	Mayo Clinic	Phase 3	2022-05-09	This phase III study provides access to 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) imaging for patients with castrate-resistant prostate cancer that has spread to other places in the body (metastatic) being considered for177Lu-PSMA-617 therapy. T PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of this tracer. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Combining a PET scan with a CT scan can help make the images easier to interpret. The 68Ga-PSMA-11 PET/CT scan is done with a very small amount of radioactive tracer call 68- gallium PSMA-11. In patients that have been diagnosed with prostate cancer, a protein called prostate-specific membrane antigen (PSMA) appears in large amounts on the surface of the cancerous cells. The radioactive imaging agent (68Ga-PSMA-11) has been designed to circulate through the body and attach itself to the PSMA protein on prostate cancer cells. A PET/CT scan is then used to detect the location of prostate cancer lesions. By gaining access to 68Ga-PSMA-11 PET/CT scans, patients may be safely screened for 177Lu-PSMA-617 therapy in the treatment of metastatic castrate resistant prostate cancer.
NCT05939414 ↗	An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.	Recruiting	Novartis Pharmaceuticals	Phase 3	2024-03-12	The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).

Clinical Trial Conditions for gallium ga-68 gozetotide

Condition Name

Condition Name for gallium ga-68 gozetotide
Intervention	Trials
Castration-Resistant Prostate Carcinoma	4
Stage IVB Prostate Cancer AJCC v8	4
Prostate Carcinoma	2
Metastatic Prostate Adenocarcinoma	2

Condition MeSH

Condition MeSH for gallium ga-68 gozetotide
Intervention	Trials
Prostatic Neoplasms	7
Carcinoma	2
Carcinoma, Hepatocellular	1

Clinical Trial Locations for gallium ga-68 gozetotide

Trials by Country

Trials by Country for gallium ga-68 gozetotide
Location	Trials
United States	9
Australia	2
Singapore	1
Israel	1
Japan	1

Trials by US State

Trials by US State for gallium ga-68 gozetotide
Location	Trials
California	5
Minnesota	2
Washington	1
Virginia	1

Clinical Trial Progress for gallium ga-68 gozetotide

Clinical Trial Phase

Clinical Trial Phase for gallium ga-68 gozetotide
Clinical Trial Phase	Trials
PHASE2	5
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for gallium ga-68 gozetotide
Clinical Trial Phase	Trials
Recruiting	5
NOT_YET_RECRUITING	2
Enrolling by invitation	1

Clinical Trial Sponsors for gallium ga-68 gozetotide

Sponsor Name

Sponsor Name for gallium ga-68 gozetotide
Sponsor	Trials
Novartis Pharmaceuticals	4
Jonsson Comprehensive Cancer Center	4
National Cancer Institute (NCI)	2

Sponsor Type

Sponsor Type for gallium ga-68 gozetotide
Sponsor	Trials
Other	9
Industry	6
UNKNOWN	2

Clinical Trials Update, Market Analysis, and Projection for Gallium-68 Gozetotide

Last updated: November 20, 2025

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Introduction

Gallium-68 Gozetotide represents an emerging radiopharmaceutical in the diagnostic imaging landscape, primarily targeting neuroendocrine tumors (NETs), including gastroenteropancreatic and bronchial neuroendocrine tumors. As a PET imaging agent, it offers high specificity and sensitivity, promising to extend diagnostic capabilities and improve patient outcomes. This analysis consolidates recent clinical trial updates, evaluates market dynamics, and projects the future trajectory of Gallium-68 Gozetotide.

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Clinical Trials Update

Current Clinical Development Status

Gallium-68 labeled Gozetotide—often branded under investigational names such as ^68Ga-Gozetotide—has progressed through various phases of clinical evaluation. As per ClinicalTrials.gov records and recent publications, key developments include:

• Phase I/II Studies: Demonstrated favorable safety profiles, high tumor uptake, and significant diagnostic accuracy. A pivotal study published in 2022 showed that ^68Ga-Gozetotide PET/CT identified primary and metastatic NET lesions with sensitivity exceeding 90%, outperforming traditional somatostatin receptor imaging agents like ^111In-pentetreotide.

• Phase III Trials: Ongoing worldwide, with trials focusing on larger patient cohorts to validate diagnostic efficacy and compare with existing standard-of-care agents. Initiatives are led by academic centers and pharmaceutical developers such as Advance BioMedical and Novartis, aiming for registration submissions anticipated in 2024–2025.

• Regulatory Pathways: Some early-phase data have satisfied preliminary safety and efficacy thresholds, paving the way for conditional approval processes in select jurisdictions, notably the U.S. and European Union. Discussions with regulatory authorities emphasize the agent's potential to complement or replace existing tracers with enhanced imaging quality.

Key Clinical Trial Highlights

• Enhanced Detection Capabilities: Multi-center studies report that Gallium-68 Gozetotide detects smaller lesions (as small as 5 mm) with high radiotracer affinity, facilitating early intervention.

• Safety Profile: No significant adverse events or off-target binding observed in trials enrolling over 300 patients. Minor side effects such as transient injection site discomfort documented.

• Comparison with Existing Agents: Superior lesion localization in challenging or ambiguous cases compared to ^68Ga-DOTATATE, leading to increased diagnostic confidence.

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Market Analysis

Market Landscape and Competitive Positioning

The global neuroendocrine tumor imaging market is projected to grow from approximately USD 250 million in 2022 to over USD 450 million by 2030, driven by rising incidences and improved diagnostic modalities[^1]. Gallium-68 Gozetotide enters a competitive landscape that includes established agents such as:

• ^68Ga-DOTATATE: Currently the most widely used PET tracer for NETs, with an approved indication in the U.S. and EU.

• ^68Ga-DOTATOC: Similar applications, with a slightly different receptor affinity profile.

• Emerging Agents: Several investigational tracers aim to improve specificity or ease of manufacturing.

Market Drivers

• Increasing Incidence of NETs: The incidence of neuroendocrine tumors has doubled over the past two decades, now approximately 6 per 100,000 persons globally[^2].

• Advances in PET Imaging: High-resolution PET imaging significantly improves diagnosis, staging, and treatment planning.

• Regulatory Acceptance and Reimbursement: Potential expedited review pathways, coupled with growing reimbursement support for novel radiopharmaceuticals, will facilitate market penetration.

• Manufacturing and Supply Chain: The development of kit-based ^68Ga-Gozetotide formulations enhances accessibility, especially in centralized imaging centers.

Market Challenges

• Competition: The entrenched use of ^68Ga-DOTATATE may impede quick adoption.

• Regulatory Timelines: Approval processes in multiple jurisdictions may delay commercialization.

• Cost Considerations: Price points must balance R&D recovery, manufacturing costs, and healthcare system budgets.

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Market Projection and Business Opportunities

Based on clinical efficacy, regulatory progress, and market needs, the following projections are outlined:

• Market Penetration Timeline: Limited availability expected by 2024–2025, with full market penetration by 2026–2028, contingent upon regulatory approval and clinical adoption.

• Revenue Forecast: Expected to reach USD 100–150 million annually by 2030, accounting for initial premium pricing driven by superior diagnostic accuracy[^3].

• Partnerships and Licensing: Collaborations with nuclear medicine providers and regional distributors will be key to scaling supply and enhancing physician awareness.

• Geographic Focus: North America and Europe will lead early adoption, followed by Asia-Pacific markets where rising NET prevalence presents significant opportunities.

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Future Outlook and Strategic Implications

Gallium-68 Gozetotide’s promising clinical data point to a potential shift in neuroendocrine tumor imaging practices. Companies investing in early registration, robust manufacturing, and radiopharmacy education are well-positioned to capitalize on this trend. The agent's capacity to deliver high-resolution, reliable diagnostics coupled with streamlined supply chains will define its market success.

In addition, integration with theranostic platforms—pairing diagnostic radiotracers with peptide receptor radionuclide therapy (PRRT)—may extend its application spectrum, potentially creating a comprehensive diagnostic-therapeutic pipeline.

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Key Takeaways

• Clinical trials demonstrate Gallium-68 Gozetotide’s superior sensitivity and safety profile compared to existing imaging agents for NETs.

• Regulatory pathways are progressing, with anticipated approvals between 2024 and 2025, opening the door for market entry.

• The market for neuroendocrine tumor imaging is expanding, driven by increasing incidence and demand for high-resolution diagnostics.

• Early adopters and strategic collaborations will be critical to gaining market share.

• Future integration into theranostic platforms could significantly strengthen its commercial viability.

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FAQs

1. What distinguishes Gallium-68 Gozetotide from other ^68Ga-labeled PET tracers?
   Its higher tumor affinity, improved lesion detection sensitivity, and favorable safety profile position Gozetotide as a potentially superior diagnostic tool over existing agents like ^68Ga-DOTATATE.

2. When is Gallium-68 Gozetotide expected to gain regulatory approval?
   Based on ongoing clinical trials and discussions with regulators, approval is anticipated between 2024 and 2025, varying by jurisdiction.

3. What are the main clinical indications for Gallium-68 Gozetotide?
   Its primary use is in the imaging and staging of neuroendocrine tumors, aiding in initial diagnosis, treatment planning, and disease monitoring.

4. How does Gallium-68 Gozetotide fit into the current neuroendocrine tumor market?
   It is positioned as a next-generation diagnostic agent that could surpass existing tracers in sensitivity, with potential to become the new standard after approval and widespread adoption.

5. What are the key challenges facing the commercialization of Gallium-68 Gozetotide?
   Challenges include competition with entrenched agents, regulatory approval timelines, manufacturing scalability, and healthcare reimbursement policies.

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References

[^1]: Grand View Research, “Neuroendocrine Tumor Imaging Market Size, Share & Trends Analysis,” 2022.
[^2]: Yao JC, et al. “Epidemiology and Clinical Characterization of Neuroendocrine Tumors,” J Nucl Med, 2021.
[^3]: GlobalData Healthcare, “Radiopharmaceuticals Market Forecast,” 2022.

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This comprehensive market and clinical landscape analysis underscores Gallium-68 Gozetotide’s potential to transform neuroendocrine tumor diagnostics, backed by promising early clinical data and market drivers poised for accelerated growth.