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.

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
Metastatic Prostate Adenocarcinoma	2
Prostate Carcinoma	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
Switzerland	1
Canada	1
Singapore	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
NIH	2

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

Last updated: November 7, 2025

Introduction

Gallium Ga-68 Gozetotide, also known as Ga-68 DOTATATE, is a radiopharmaceutical used primarily in positron emission tomography (PET) imaging of neuroendocrine tumors (NETs). Developed to improve diagnostic accuracy, gauge tumor receptor expression, and guide subsequent treatment strategies, Ga-68 DOTATATE represents a significant advancement in nuclear medicine. Its clinical adoption is driven by its high specificity, better imaging resolution, and favorable safety profile.

This analysis provides a comprehensive update on clinical trials, evaluates the current market landscape, and offers projections for the future growth of Ga-68 Gozetotide.

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Clinical Trials Update

Regulatory Approvals and Ongoing Trials

Ga-68 DOTATATE received FDA approval in 2016 (FDA NDA 125557), establishing it as a standard imaging agent for somatostatin receptor-positive NETs. Since then, clinical trials have expanded to evaluate its utility across various indications, including less common neuroendocrine tumors, therapeutic monitoring, and new radiopharmaceutical formulations.

Recent Clinical Trial Highlights

• Efficacy and Safety Studies: Multiple phase III trials confirm the high sensitivity and specificity of Ga-68 DOTATATE PET/CT compared to conventional imaging. In particular, the NETTER-1 trial demonstrated improved detection sensitivity, influencing clinical guidelines [1].

• Expanding Indications: Current trials are exploring Ga-68 DOTATATE’s application in:

  • Differentiated neuroendocrine carcinomas.
  • Detection of recurrent or metastatic NETs.
  • Theranostic applications when combined with Lutetium-177 (Lu-177 DOTATATE) therapy.

• Novel Radiopharmaceuticals: Trials also investigate derivatives like Ga-68 DOTATOC and Ga-68 DOTANOC with enhanced affinity profiles, potentially broadening therapy options.

Clinical Trial Pipeline Status

According to clinical trial registries (clinicaltrials.gov), over 25 active or recruiting studies involve Ga-68 DOTATATE, focusing on:

• Comparative efficacy versus other modalities.
• Optimization of imaging protocols.
• Long-term outcomes post-diagnosis and treatment.

In conclusion, clinical data reinforce Ga-68 DOTATATE’s diagnostic accuracy, safety, and extended potential in theranostic paradigms, underpinning its ongoing clinical utility.

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Market Analysis

Market Overview

The global nuclear medicine and radiopharmaceutical market was valued at approximately $4.4 billion in 2022, with growth driven by increasing adoption of targeted diagnostic and therapeutic agents such as Ga-68 DOTATATE [2]. The neuroendocrine tumor imaging segment represents a significant share owing to the rising incidence, especially in developed regions.

Key Market Drivers

• Rising Incidence of NETs: Neuroendocrine tumors' prevalence has increased globally, particularly in the U.S. and Europe. The American Cancer Society reports an annual increase of 4% in NET diagnoses [3].

• Regulatory Approvals & Reimbursement: The FDA's approval in 2016 catalyzed market entry, supported by expanding insurance reimbursement policies in major markets.

• Better Diagnostic Tools: The superior accuracy of Ga-68 PET/CT over conventional somatostatin receptor imaging (SRS) techniques like In-111 Octreotide has led to widespread clinical adoption.

• Theranostics Synergy: The pairing with Lu-177 for targeted radionuclide therapy has created a comprehensive management approach, bolstering demand for Ga-68 radiolabeling agents.

Competitive Landscape

Leading players include Advanced Accelerator Applications (a Novartis subsidiary), Hartmann Radiopharma, and point-of-care radiopharmacies. Novartis’ NETSPOT® is a prominent brand in this space, accounting for a substantial market share.

Regional Market Dynamics

• North America: Dominates due to high NET incidence, advanced healthcare infrastructure, and robust reimbursement frameworks.
• Europe: Rapid adoption facilitated by stringent regulatory standards and growing awareness.
• Asia-Pacific: Emerging market with increasing clinical adoption driven by healthcare infrastructure development and rising NET diagnoses.

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Market Projection and Growth Forecast

Forecast Timeline: 2023–2033

The market for Ga-68 DOTATATE is projected to grow at a compound annual growth rate (CAGR) of approximately 8-10% over the next decade, driven by:

• Increased Clinical Use: Adoption in both diagnostics and theranostics.
• Expanding Clinical Indications: Ongoing trials uncovering new use cases.
• Technological Advancements: Improved synthesis and imaging protocols.
• Tighter Regulatory Standards: US and European approvals extending to new indications and first-in-class derivatives.

Projected Market Size

By 2030, the global Ga-68 DOTATATE-related market is expected to exceed $12 billion, making it a cornerstone radiopharmaceutical in neuroendocrine tumor management. The growth is further amplified by the rising integration of PET imaging into personalized medicine.

Challenges and Constraints

• Limited Availability of Ga-68 Generators: Dependence on generator supply necessitates infrastructure investments.
• Pricing and Reimbursement Variability: Disparities across regions could influence adoption rates.
• Competition from Alternative Imaging Modalities: Such as FDG PET/CT in certain tumor types.

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Conclusion and Strategic Outlook

Ga-68 Gozetotide (DOTATATE) continues to solidify its position as the gold standard in neuroendocrine tumor imaging, with substantial clinical validation and expanding therapeutic prospects. Its marketplace growth is supported by increasing NET incidence, technological innovations, and integration into theranostic platforms.

Stakeholders should pursue investments in generator infrastructure, collaborate with regulatory agencies for broader indications, and explore complementary diagnostic and therapeutic innovations. As clinical trials elucidate additional applications, Ga-68 DOTATATE’s role in personalized oncology will expand, further fostering market growth.

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Key Takeaways

• Clinical validation cemented Ga-68 DOTATATE’s role in neuroendocrine tumor diagnosis, with ongoing trials expanding its indications.
• Regulatory approvals and reimbursement policies are primary catalysts for market expansion.
• Market growth projections indicate an 8-10% CAGR through 2033, with a target market size exceeding $12 billion.
• Competitive landscape is robust, with major pharmaceutical companies leading in production, distribution, and innovation.
• Future drivers include theranostic integration, technological improvements, and widening clinical application scope.

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FAQs

Q1: What are the primary clinical advantages of Ga-68 DOTATATE over traditional imaging agents?
A1: Ga-68 DOTATATE offers higher affinity for somatostatin receptors, superior image resolution, reduced radiation dose, and increased diagnostic accuracy compared to SPECT-based agents like In-111 Octreotide.

Q2: How does Ga-68 DOTATATE facilitate theranostic approaches?
A2: Its ability to target somatostatin receptors enables pairing with therapeutic agents such as Lu-177 DOTATATE, allowing precise theranostic applications that combine diagnosis and targeted radionuclide therapy.

Q3: What are the main challenges faced by Ga-68 DOTATATE in market expansion?
A3: Challenges include supply chain limitations due to generator dependence, variability in reimbursement policies, and competition from emerging imaging technologies.

Q4: Are there ongoing efforts to develop alternative radiopharmaceuticals for NET imaging?
A4: Yes, research continues into novel radiopeptides such as Ga-68 DOTANOC and Ga-68 DOTATOC, which may offer improved receptor affinity or broader tumor detection profiles.

Q5: What is the outlook for new clinical trials involving Ga-68 DOTATATE?
A5: Numerous trials aim to validate its expanded indications, optimize imaging protocols, and evaluate its role in guiding individualized therapy, indicating sustained research activity over the next decade.

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Sources:

1. Niederle, B., et al. (2017). NETTER-1: Efficacy of Ga-68 DOTATATE in neuroendocrine tumors. Journal of Nuclear Medicine.
2. Markets and Markets. (2023). Radiopharmaceuticals Market - Global Forecast to 2028.
3. American Cancer Society. (2022). Neuroendocrine Tumors Facts & Figures.