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
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).
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.
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.
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.

Clinical Trial Conditions for gallium ga-68 gozetotide

Condition Name

Condition Name for gallium ga-68 gozetotide
Intervention	Trials
Stage IVB Prostate Cancer AJCC v8	2
Castration-Resistant Prostate Carcinoma	2
Oligometastatic Prostate Cancer (OMPC)	1
Stage IV Prostate Cancer AJCC v8	1

Condition MeSH

Condition MeSH for gallium ga-68 gozetotide
Intervention	Trials
Prostatic Neoplasms	3
Carcinoma	2
Carcinoma, Hepatocellular	1

Clinical Trial Locations for gallium ga-68 gozetotide

Trials by Country

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−

Trials by Country for gallium ga-68 gozetotide
Location	Trials
United States	4
Australia	2
Singapore	1
Israel	1
Japan	1

Trials by US State

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−

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

Clinical Trial Progress for gallium ga-68 gozetotide

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for gallium ga-68 gozetotide
Clinical Trial Phase	Trials
Recruiting	2
Enrolling by invitation	1
Not yet recruiting	1

Clinical Trial Sponsors for gallium ga-68 gozetotide

Sponsor Name

Sponsor Name for gallium ga-68 gozetotide
Sponsor	Trials
Mayo Clinic	2
National Cancer Institute (NCI)	1
Eli Lilly and Company	1

Sponsor Type

Sponsor Type for gallium ga-68 gozetotide
Sponsor	Trials
Other	4
Industry	2
NIH	1

Gallium Ga 68 Gozetotide: Clinical Trials, Market Analysis, and Projections

Introduction

Gallium Ga 68 Gozetotide, also known as PSMA-11, is a radioactive diagnostic agent used in positron emission tomography (PET) for the detection of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Study Overview

The efficacy of Gallium Ga 68 Gozetotide has been established through several prospective studies. One notable study, the PSMA-PreRP study, involved 123 patients with suspected metastasis or recurrence of prostate cancer. This study compared Gallium Ga 68 Gozetotide PET results with histopathology from dissected pelvic lymph nodes[1].

Diagnostic Performance

The study showed that Gallium Ga 68 Gozetotide had a sensitivity of 47% and a specificity of 90% for detecting pelvic lymph node metastases. The positive predictive value (PPV) was 61%, and the negative predictive value (NPV) was 84%[1].

Patient Demographics and Outcomes

The mean age of the patients in the study was 65 years, with a median serum PSA level of 11.8 ng/mL. The study found that approximately 24% of the subjects had pelvic nodal metastases based on histopathology[1].

Safety and Dosage

The safety profile of Gallium Ga 68 Gozetotide has been established based on multiple studies. The recommended dose is 111 MBq to 259 MBq (3 mCi to 7 mCi), administered as a slow intravenous injection. Patients are advised to be well-hydrated before and after the procedure to minimize radiation exposure to the urinary bladder[4].

Market Analysis

Current Market Size and Growth

The global gallium-68 market, which includes Gallium Ga 68 Gozetotide, was valued at approximately $782.36 million in 2022. It is projected to grow to $1,070.34 million by 2030, with a compound annual growth rate (CAGR) of 4.0% during the forecast period[2].

Market Segmentation

The market is segmented by application and end user. The oncology segment, particularly prostate cancer and neuroendocrine tumors, holds the largest market share and is expected to register the highest CAGR during the forecast period. Hospitals are the primary end users, accounting for the largest market share[2].

Regional Insights

North America dominates the gallium-68 market due to advancements in nuclear medicine, access to advanced healthcare infrastructure, and the rising incidence of prostate cancer. The Asia Pacific region is also expected to grow significantly due to economic growth, improved healthcare facilities, and increasing awareness of nuclear medicine[2][5].

Market Drivers and Challenges

Drivers

• Increasing Prevalence of Prostate Cancer and Neuroendocrine Tumors: The rising incidence of these cancers is driving the demand for gallium-68 based diagnostic agents[2][5].
• Advancements in Nuclear Medicine: Technological advancements in PET imaging and the introduction of novel radiopharmaceuticals are boosting the market[2][5].
• Regulatory Approvals: Recent approvals, such as Health Canada’s approval for Illuccix (Ga-68 gozetotide injection preparation kit), are expanding the market reach[2].

Challenges

• Short Shelf-Life: The short half-life of gallium-68 (68 minutes) poses logistical challenges for its production, distribution, and use[2][5].
• Radiation Safety: The need for strict radiation safety measures during handling and administration can be a barrier to widespread adoption[1][4].

Future Projections

Market Growth

The gallium-68 market is expected to continue growing, driven by the increasing demand for advanced diagnostic tools in oncology. The market is projected to reach $1,070.34 million by 2030, with a CAGR of 4.0% from 2022 to 2030[2].

Emerging Applications

Research is ongoing for new applications of gallium-68, including therapeutic uses and imaging of other types of tumors. This could expand the market beyond its current scope[5].

Regional Expansion

Key players are planning to invest and expand their business in developing economies such as China and India, where there is a growing need for advanced nuclear medicine techniques[5].

Key Players and Competitive Landscape

Major Players

Companies like Telix Pharmaceuticals, Siemens Healthineers AG, ITM Isotopen Technologien München AG, and Advanced Accelerator Applications (a Novartis AG Company) are major players in the gallium-68 market. These companies are investing in research and development to enhance their product portfolios and expand their market reach[2][5].

Competitive Strategies

The market is competitive, with companies adopting inorganic growth strategies such as partnerships and acquisitions to strengthen their positions. The introduction of new products and technologies is also a key strategy to gain market share[2][5].

Conclusion

Gallium Ga 68 Gozetotide is a critical diagnostic tool in the management of prostate cancer, with robust clinical trial data supporting its efficacy. The market for gallium-68 is poised for significant growth, driven by increasing demand for advanced diagnostic techniques and expanding regulatory approvals. However, challenges such as the short shelf-life of gallium-68 need to be addressed to fully realize the potential of this diagnostic agent.

Key Takeaways

• Clinical Efficacy: Gallium Ga 68 Gozetotide has shown strong diagnostic performance in detecting PSMA-positive lesions in prostate cancer patients.
• Market Growth: The gallium-68 market is projected to grow to $1,070.34 million by 2030, with a CAGR of 4.0%.
• Regional Dominance: North America currently dominates the market, but the Asia Pacific region is expected to grow significantly.
• Challenges: The short shelf-life of gallium-68 and radiation safety concerns are key challenges.
• Future Prospects: Emerging applications and regional expansion are expected to drive further growth.

FAQs

What is Gallium Ga 68 Gozetotide used for?

Gallium Ga 68 Gozetotide is used for the detection of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer through positron emission tomography (PET)[1].

What are the key findings from the clinical trials of Gallium Ga 68 Gozetotide?

Clinical trials have shown that Gallium Ga 68 Gozetotide has a sensitivity of 47% and a specificity of 90% for detecting pelvic lymph node metastases in prostate cancer patients[1].

What is the current market size of the gallium-68 market?

The global gallium-68 market was valued at approximately $782.36 million in 2022[2].

What are the major drivers of the gallium-68 market?

The market is driven by the increasing prevalence of prostate cancer and neuroendocrine tumors, advancements in nuclear medicine, and regulatory approvals[2][5].

Who are the key players in the gallium-68 market?

Key players include Telix Pharmaceuticals, Siemens Healthineers AG, ITM Isotopen Technologien München AG, and Advanced Accelerator Applications (a Novartis AG Company)[2][5].

Sources

1. FDA Label: Gallium Ga 68 Gozetotide Injection - accessdata.fda.gov
2. The Insight Partners: Gallium-68 Market Forecast to 2030 | Size, Share, Growth
3. FDA NDA: 215841Orig1s000 - accessdata.fda.gov
4. Novartis: LOCAMETZ® | Novartis
5. Transparency Market Research: Gallium-68 Market Survey Report 2031