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
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.
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
Metastatic Prostate Adenocarcinoma	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
Switzerland	1
Canada	1
Singapore	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
Eli Lilly and Company	1
Prostate Cancer Foundation	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 to Gallium Ga 68 Gozetotide

Gallium Ga 68 gozetotide, also known as Ga-68 PSMA-11, is a radiopharmaceutical agent approved by the FDA for use in positron emission tomography (PET) imaging to identify and assess 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

The FDA approval of Ga 68 PSMA-11 was based on evidence from two clinical trials: Trial 1 and Trial 2.

Trial 1

This trial enrolled patients who were recently diagnosed with prostate cancer and were awaiting surgery for the removal of the prostate and nearby lymph nodes. The trial evaluated the successful detection of cancer lesions using Ga 68 PSMA-11 PET/CT imaging compared to post-surgery lymph tissue results (histopathology of the lymph nodes). Patients underwent Ga 68 PSMA-11 PET/CT imaging followed by surgery, and the images were read by three blinded independent readers and compared to histopathology obtained from dissected pelvic lymph nodes[3][4].

Trial 2

This trial enrolled patients who had already been treated for prostate cancer but had rising PSA levels, indicating possible cancer recurrence. The trial assessed the safety and efficacy of Ga 68 PSMA-11 in detecting PSMA-positive lesions in these patients. The performance of Ga 68 PSMA-11 was evaluated in terms of its ability to detect pelvic lymph node metastases and its impact on clinical decision-making[3][4].

Market Analysis

Current Market Size and Growth

The gallium-68 market, which includes Ga 68 PSMA-11, was valued at approximately $782.36 million in 2022 and 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 gallium-68 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. By end user, hospitals dominate the market, followed by diagnostic and imaging centers[2][5].

Regional Analysis

North America holds the largest market share due to advancements in technologies such as hybrid imaging, the introduction of novel radiopharmaceuticals, and the development of molecular imaging techniques. The rising incidence and prevalence of prostate cancer in the region also contribute to the market growth. Asia Pacific and Europe are also significant markets, driven by 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 rise in these conditions drives the demand for gallium-68-based diagnostic tools.
• Advancements in Nuclear Medicine: Innovations in PET imaging and the introduction of new radiopharmaceuticals are key drivers.
• Growing Awareness and Healthcare Infrastructure: Improved access to advanced healthcare facilities, especially in North America and Asia Pacific, supports market growth[2][5].

Challenges

• Short Shelf-Life: Gallium-68 has a half-life of 68 minutes, which can impede its widespread use and distribution.
• Radiation Safety and Handling: The need for strict radiation safety measures and aseptic techniques during administration can be a challenge[2][4].

Future Projections

Market Growth

The gallium-68 market is expected to continue growing, driven by the increasing prevalence of cancer, advancements in nuclear medicine, and the expanding use of PET imaging. 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 its use in cardiology, respiratory, and urology. Newer 68Ga-labeled tracers are being explored for various therapeutic applications and in nuclear imaging, which could further propel the market[5].

Regional Expansion

Asia Pacific and Europe are expected to see significant growth due to economic development, improved healthcare facilities, and increasing consumer awareness. Major market players are planning to invest and expand their business in these regions[5].

Key Takeaways

• Clinical Trials: Ga 68 PSMA-11 was approved based on two clinical trials that demonstrated its efficacy in detecting PSMA-positive lesions in prostate cancer patients.
• Market Size and Growth: The gallium-68 market is projected to grow from $782.36 million in 2022 to $1,070.34 million by 2030, with a CAGR of 4.0%.
• Market Segmentation: The oncology segment, particularly prostate cancer, dominates the market, with hospitals being the primary end users.
• Regional Analysis: North America leads the market, followed by Asia Pacific and Europe.
• Drivers and Challenges: The market is driven by the increasing prevalence of cancer and advancements in nuclear medicine, but faces challenges such as the short shelf-life of gallium-68.

FAQs

Q: What is Ga 68 PSMA-11 used for?

Ga 68 PSMA-11 is a radiopharmaceutical agent used for positron emission tomography (PET) imaging to identify and assess prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer.

Q: What were the key findings of the clinical trials for Ga 68 PSMA-11?

The clinical trials demonstrated the efficacy of Ga 68 PSMA-11 in detecting PSMA-positive lesions in prostate cancer patients, both in primary staging and in suspected recurrence based on elevated PSA levels.

Q: What is the current market size and growth projection for the gallium-68 market?

The gallium-68 market was valued at $782.36 million in 2022 and is projected to grow to $1,070.34 million by 2030, with a CAGR of 4.0%.

Q: Which regions are expected to drive the growth of the gallium-68 market?

North America currently leads the market, but Asia Pacific and Europe are expected to see significant growth due to economic development and improved healthcare facilities.

Q: What are the main challenges facing the gallium-68 market?

The main challenges include the short shelf-life of gallium-68 and the need for strict radiation safety and handling measures during administration.

Sources

1. DrugBank: Ga 68 PSMA-11: Uses, Interactions, Mechanism of Action.
2. The Insight Partners: Gallium-68 Market Forecast to 2030 | Size, Share, Growth.
3. FDA: Drug Trials Snapshot: Ga 68 PSMA-11.
4. FDA: GALLIUM GA 68 GOZETOTIDE Injection.
5. Transparency Market Research: Gallium-68 Market Survey Report 2031.