Ga 68 PSMA PET/CT Imaging for Liver Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Breastfeeding, Weight/size limits

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 36 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new imaging method using 68Ga-PSMA PET scans (Gallium Ga 68 Gozetotide) can improve the diagnosis and management of advanced liver cancer. The process uses a radioactive compound that targets a specific protein on liver cancer cells, enabling doctors to pinpoint the cancer's exact location with a PET scan. This could lead to more effective treatment strategies. The trial seeks participants with liver cancer that cannot be treated with surgery or other curative methods and who are eligible for specific immunotherapy treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to advancements in liver cancer care.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this imaging technique is safe for diagnosing liver cancer?

Research has shown that Gallium Ga 68 Gozetotide is generally safe for people. In studies, the injection caused very few side effects, occurring in less than 1% of patients. Importantly, no serious side effects were linked to this compound. This suggests it is quite safe for use in PET scans, which detect cancer cells in the body. While researchers continue to study this treatment for liver cancer, the FDA has already approved it for imaging in prostate cancer, reinforcing its safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for liver cancer, which typically involves surgery, chemotherapy, and radiation, Gallium Ga 68 Gozetotide offers a novel diagnostic approach. This treatment uses a radiotracer that specifically targets prostate-specific membrane antigen (PSMA), which can be overexpressed in liver cancer cells. Researchers are excited about its potential to provide clearer images of cancer spread and response to treatment, allowing for more precise monitoring and potentially improving treatment outcomes. This innovative imaging technique could pave the way for more personalized and effective treatment strategies for liver cancer.

What evidence suggests that this imaging technique is effective for diagnosing advanced liver cancer?

Research has shown that 68-Gallium prostate specific membrane antigen (68Ga-PSMA) PET imaging is promising for detecting tumors. This trial will use 68Ga-PSMA PET/CT scans to assess liver cancer. The method employs a special compound that binds to the PSMA protein on liver cancer cells, making them visible during a PET scan. Studies have demonstrated that 68Ga-PSMA scans can effectively locate tumors, aiding doctors in better managing and treating liver cancer. Evidence also suggests these scans can predict a patient's response to certain treatments. This technique has proven useful in other cancers, such as prostate cancer, indicating its potential effectiveness in liver cancer as well. ^{4 6 7 8 9}

Who Is on the Research Team?

Nguyen H. Tran, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced liver cancer that can't be removed by surgery or treated with curative intent. They must have a type of tumor that can be measured and be eligible for specific front-line therapy. Pregnant or breastfeeding individuals, or those too large for the PET/CT scanner are excluded.

Inclusion Criteria

Have radiographically measurable disease by RECIST

I am eligible for atezolizumab/bevacizumab as my first treatment.

My liver cancer cannot be treated with surgery, transplant, or targeted therapies.

Exclusion Criteria

Pregnant and/or breast-feeding patients. A negative pregnancy test within 48 hours of the PET scan

Patients with higher than the weight/size limitations of PET/CT scanner

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Patients undergo 68GA PSMA PET/CT scans at baseline

1 week

1 visit (in-person)

Treatment

Patients receive standard of care immunotherapy and undergo 68GA PSMA PET/CT scans after 3, 6, 9, and 12 cycles

36 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness every 6 months for 3 years after treatment

3 years

6 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Computed Tomography
• Gallium Ga 68 Gozetotide
• Positron Emission Tomography

Trial Overview

The trial is testing if a new imaging technique using a radioactive compound called 68Ga-PSMA improves diagnosis and management of advanced liver cancer. It involves PET scans to detect tumors after the compound binds to proteins on cancer cells.

How Is the Trial Designed?

Group I: Treatment (68GA PSMA PET/CT) Experimental Treatment 3 Interventions

Patients undergo 68GA PSMA PET/CT scans at baseline, and after 3, 6, 9, and 12 cycles of standard of care immunotherapy in the absence of disease progression or unacceptable toxicity.

Gallium Ga 68 Gozetotide is already approved in United States, European Union for the following indications:

Approved in United States as Gallium Ga 68 Gozetotide for:

• Prostate cancer
• Hepatocellular carcinoma (liver cancer)

Approved in European Union as 68Ga-PSMA-11 for:

• Prostate cancer
• Hepatocellular carcinoma (liver cancer)

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a pilot study involving seven patients with hepatocellular carcinoma (HCC), 68Ga-PSMA PET-CT was found to be significantly more effective than 18F-FDG PET-CT for imaging HCC lesions, with 36 out of 37 tumor lesions showing increased 68Ga-PSMA uptake.

The study revealed that HCC lesions are often hypervascular, correlating with higher 68Ga-PSMA uptake in tumor micro-vessels, suggesting that 68Ga-PSMA PET-CT could be a promising new imaging technique for detecting HCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA is a novel PET-CT tracer for imaging of hepatocellular carcinoma: A prospective pilot study. Kesler, M., Levine, C., Hershkovitz, D., et al.[2022]

This case study is the first to report that gallium-68 (68Ga)-PSMA PET/CT can effectively identify well-differentiated hepatocellular carcinoma (HCC), which was not clearly characterized by other imaging methods like MRI and 18F-choline PET/CT.

The patient, who had a history of prostate cancer, showed significant tracer uptake in the HCC lesion on 68Ga-PSMA PET/CT, suggesting that this imaging technique may be a promising tool for detecting HCC, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case of Well-differentiated Hepatocellular Carcinoma Identified on Gallium-68 Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography. Huang, HL., Zhen Loh, TJ., Hoe Chow, PK.[2022]

(68)Ga-PSMA PET/CT is a highly sensitive diagnostic tool for detecting primary prostate cancer and its metastases, outperforming traditional fluorine-18 choline PET/CT by identifying more metastases at lower PSA levels.

The (68)Ga-PSMA radioligand can be produced in hospitals using a gallium generator, making it a convenient and accessible option for prostate cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Not Available]. Lavalaye, J., Lam, MG., Verzijlbergen, JF., et al.[2021]

68Ga-PSMA is a highly effective radiotracer not only for prostate cancer but also for detecting other solid tumors, as demonstrated in a case of an 82-year-old man with hepatocellular carcinoma, where it revealed significant disease progression not seen on CT scans.

The use of 68Ga-PSMA PET/CT in this patient identified high PSMA-expressing lesions and unexpected bone metastases, suggesting that it can play a crucial role in guiding treatment decisions, including potential radionuclide therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occult Bone Metastases From Hepatocellular Carcinoma Detected on 68Ga-PMSA PET/CT. Usmani, S., Rasheed, R., Al Kandari, F., et al.[2023]

The study demonstrated that [68Ga]Ga-PSMA-11 PET/CT imaging is safe for use in patients with hepatocellular carcinoma (HCC), with no adverse events reported, and it effectively detects PSMA expression in vivo.

In 33% of the patients, the results from the PET/CT imaging led to changes in their treatment strategies, highlighting its potential impact on patient management in HCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[68 Ga]Ga-Prostate-Specific Membrane Antigen PET/CT: a novel method for imaging patients with hepatocellular carcinoma. Kunikowska, J., Cieślak, B., Gierej, B., et al.[2021]

68Ga-PSMA PET/CT is highly effective for detecting recurrent prostate cancer, identifying cancer sites in 81% of patients with rising PSA levels after treatment, and showing a 50% detection rate for PSA levels between 0.2-0.49 ng/ml.

The imaging method demonstrated no reported adverse effects, making it a safe option for patients, and it outperformed traditional imaging methods like bone scans in detecting early recurrence of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-Labeled Prostate-specific Membrane Antigen Ligand Positron Emission Tomography/Computed Tomography for Prostate Cancer: A Systematic Review and Meta-analysis. von Eyben, FE., Picchio, M., von Eyben, R., et al.[2022]

The novel 68Ga-THP PSMA PET/CT imaging technique was found to be safe for use in prostate cancer patients, with no serious adverse events reported and only minor side effects observed in two patients.

This imaging method led to a change in clinical management for 42.9% of the patients evaluated, indicating its potential effectiveness in guiding treatment decisions for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase II, Open-label study to assess safety and management change using 68Ga-THP PSMA PET/CT in patients with high risk primary prostate cancer or biochemical recurrence after radical treatment: The PRONOUNCED study. Afaq, A., Payne, H., Davda, R., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8882890/

68Ga-PSMA-11 PET/CT Improves Tumor Detection and ...

During the observation period, disease progression after initial 68Ga-PSMA-11 PET was noted for 26 of 40 patients (65%) as follows: 13 of 40 by follow-up ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05176223?term=GOZETOTIDE&viewType=Table&rank=5

68Ga PSMA PET Imaging for the Treatment of Advanced ...

A PET scan is then used to detect the location of the tumor cells. 68Ga-PSMA PET may improve upon the diagnosis and management of liver cancer. Detailed ...

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pubs.rsna.org

pubs.rsna.org/doi/full/10.1148/radiol.233460

Quantitative 68Ga-PSMA-11 PET and Clinical Outcomes in ...

Baseline 68Ga-PSMA-11 PET/CT whole-body tumor SUVmean was the best predictor of 177Lu-PSMA-617 efficacy in participants in the VISION trial.

4.

asco.org

asco.org/abstracts-presentations/ABSTRACT366868

[68Ga]Ga-PSMA-11 PET baseline imaging as a prognostic ...

Data support use of 68Ga-PSMA-11 PET/CT scan to identify pts who will benefit from PSMA-targeted radioligand therapy.

5.

illuccixhcp.com

illuccixhcp.com/efficacy/

Clinical Efficacy | Illuccix® (kit for the preparation of gallium Ga ...

View the established clinical efficacy for Illuccix® across prostate cancer stages demonstrated in pivotal trials with ⁶⁸Ga-PSMA-11.

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accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2022/212643s002lbl.pdf

GALLIUM GA 68 GOZETOTIDE Injection - accessdata.fda.gov

The safety and effectiveness of Gallium Ga 68 Gozetotide Injection have not been established in pediatric patients. 8.5 Geriatric Use. The efficacy of Gallium ...

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illuccixhcp.com

illuccixhcp.com/safety/

Safety Profile | Illuccix® (kit for the preparation of gallium Ga ...

Ga-PSMA-11a PET/CT was well-tolerated with few adverse reactions, all ≤1% · No serious adverse reactions were attributed to 68Ga-PSMA-11 Injection · In clinical ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8401928/

[68Ga]Ga-PSMA-11: The First FDA-Approved 68Ga ...

In numerous partly multicentric retrospective studies, [68Ga]Ga-PSMA-11 PET imaging has significantly improved the detection of recurrent prostate cancer as ...

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illuccixhcp.com

illuccixhcp.com/wp-content/uploads/illuccix-prescribing-information.pdf

illuccix-prescribing-information.pdf

On ILLUCCIX PET images, compare uptake of gallium Ga 68 gozetotide at sites of suspected prostate cancer (lesions) with uptake in normal liver. Lesions should ...