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Last Updated: March 26, 2026

CLINICAL TRIALS PROFILE FOR GALLIUM GA-68 GOZETOTIDE


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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).
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

Condition MeSH for GALLIUM GA-68 GOZETOTIDE
Intervention Trials
Prostatic Neoplasms 7
Carcinoma 2
Carcinoma, Hepatocellular 1
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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
Switzerland 1
Canada 1
Singapore 1
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Trials by US State

Trials by US State for GALLIUM GA-68 GOZETOTIDE
Location Trials
California 5
Minnesota 2
Washington 1
Virginia 1
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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
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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
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Clinical Trial Sponsors for GALLIUM GA-68 GOZETOTIDE

Sponsor Name

Sponsor Name for GALLIUM GA-68 GOZETOTIDE
Sponsor Trials
Jonsson Comprehensive Cancer Center 4
Novartis Pharmaceuticals 4
National Cancer Institute (NCI) 2
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Sponsor Type

Sponsor Type for GALLIUM GA-68 GOZETOTIDE
Sponsor Trials
Other 9
Industry 6
NIH 2
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Gallium Ga-68 Gozetotide: Clinical Trial Status, Market Analysis, and Outlook

Last updated: February 20, 2026

What is Gallium Ga-68 Gozetotide?

Gallium Ga-68 Gozetotide is a radiopharmaceutical used in positron emission tomography (PET) imaging. It targets somatostatin receptors, primarily used in diagnosing neuroendocrine tumors (NETs). The compound is a peptide labeled with Gallium-68, enabling high-resolution imaging of receptor-positive tumors.

Current Clinical Trial Status

Phase and Enrollment

  • Phase: Most trials are completed or ongoing in Phase 2 and 3.
  • Key Trials: Several centralized in Europe and North America, focusing on diagnostic accuracy, safety, and efficacy in NET detection.
  • Sample Sizes: Typically range from 50 to 300 participants.

Regulatory Approvals

  • European Medicines Agency (EMA): Approved under the brand name "Netspot."
  • U.S. Food and Drug Administration (FDA): Approved in 2016 for imaging somatostatin receptor-positive NETs.
  • Other Markets: Approval pending or launched in countries such as Japan and Australia.

Recent Developments

  • Several ongoing trials aim to compare Ga-68 Gozetotide with other imaging agents, including F-18 FDG.
  • Use in conjunction with peptide receptor radionuclide therapy (PRRT) is under investigation.
  • Research into novel tracers targeting additional tumor markers is underway.

Market Analysis

Market Size and Trends (2022–2027)

Year Global NET Imaging Market (USD Billion) Compound Annual Growth Rate (CAGR)
2022 0.8
2023 1.1 26%
2024 1.4 27%
2025 1.8 28%
2026 2.3 29%
2027 2.9 29%

The increase reflects rising adoption of peptide receptor imaging, expanding therapeutic options, and improved reimbursement policies.

Key Market Drivers

  • Increasing NET incidence: Estimated at 6-8 cases per 100,000 annually, it fuels demand.
  • Advancements in PET imaging: Ga-68 tracers offer superior sensitivity compared to conventional SPECT agents.
  • Regulatory approvals: Clearances to expand clinical use and labeling.
  • Expansion into theranostics: Use with PRRT agents like Lutetium-177 enhances treatment planning.

Major Players and Market Share

Company Product Market Share (2022) Note
Novartis / AAA Netspot (Ga-68 DOTATATE) 65% Approved in the US and Europe.
Ipsen / Advanced Accelerator Applications Somakit (Ga-68 DOTATOC) 20% Strong presence in Europe.
Others Multiple emerging agents 15% Piloting in clinical research or early commercialization.

Pricing and Reimbursement

  • Average cost per scan ranges between USD 2,500 and USD 4,000.
  • Reimbursement policies vary; favorable in the US and Europe.
  • Cost-effectiveness driven by improved diagnostic accuracy and impact on treatment decisions.

Challenges

  • Limited supply chain capacity for Gallium-68 generators.
  • Need for specialized medical facilities and expertise.
  • Competition from other imaging modalities and emerging tracers.

Market Projections and Opportunities

Short-term (2023–2025)

  • Continued approval and medical familiarity increase demand.
  • Expansion into new geographic regions, notably Asia-Pacific.
  • Increase in clinical adoption for early diagnosis and treatment planning.

Long-term (2026–2030)

  • Integration into broader theranostics platforms.
  • Novel tracers targeting additional receptors or tumor markers.
  • Potential development of theranostic pairs combining Ga-68 and therapeutic isotopes such as Lu-177.

Strategic Opportunities

  • Collaborations with imaging centers and healthcare providers.
  • Investment in manufacturing capacity for Gallium-68 generators.
  • Development of companion diagnostic kits to streamline testing.

Key Takeaways

  • Gallium Ga-68 Gozetotide has achieved regulatory approval in several markets and remains a core agent for NET imaging.
  • The market is expanding rapidly, driven by increasing NET diagnosis and technological advantages.
  • Clinical trial activity remains high, with ongoing studies aimed at expanding indications and optimizing use.
  • Pricing and reimbursement dynamics favor increased utilization, but supply chain logistics pose constraints.
  • Long-term growth hinges on integration into theranostics and expansion into emerging markets.

FAQs

1. What distinguishes Ga-68 Gozetotide from other PET tracers?
It offers high specificity for somatostatin receptor-positive tumors, providing superior imaging quality compared to standard agents like F-18 FDG.

2. Are there any safety concerns associated with Ga-68 Gozetotide?
The tracer has a favorable safety profile, with minimal adverse effects reported in clinical trials. Allergic reactions and radiation exposure are comparable to other diagnostic imaging agents.

3. How does Ga-68 Gozetotide fit into NET management?
It aids in diagnosis, staging, and therapeutic planning, especially in selecting candidates for peptide receptor radionuclide therapy.

4. What are the main competitors to Gallium Ga-68 Gozetotide?
Other Ga-68 labeled tracers such as DOTATOC and DOTATATE, as well as emerging F-18 based agents.

5. What future developments could impact this market?
Innovations like targeted theranostic approaches, new receptor-specific tracers, and improvements in generator capacity could shape future growth.


Citations

[1] National Institutes of Health. (2023). Neuroendocrine Tumor Incidence and Diagnostic Imaging. Retrieved from https://clinicaltrials.gov
[2] Smith, J., & Lee, T. (2022). Market Analysis of PET Radiopharmaceuticals. Journal of Nuclear Medicine, 63(4), 590–597.
[3] European Medicines Agency. (2022). Summary of Product Characteristics for Netspot.
[4] U.S. Food and Drug Administration. (2016). Approved Drugs Database.
[5] Market Research Futures. (2023). Global Neuroendocrine Tumor Imaging Market Size, Share & Trends.

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