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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial tests whether 68-Gallium prostate specific membrane antigen (68Ga-PSMA) positron emission tomography (PET) imaging can improve the diagnosis and management of liver cancer that has spread to other parts of the body (advanced). PSMA is a protein that appears in large amounts on the surface of liver cancer cells. The radioactive chemical compound (68Ga-PSMA) has been designed to circulate through the body and attach itself to the PSMA protein on liver cancer cells. 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.

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 data supports the effectiveness of the treatment Ga 68 PSMA PET/CT Imaging for Liver Cancer?

Research shows that Ga 68 PSMA PET/CT is effective in imaging liver cancer (hepatocellular carcinoma) by highlighting cancerous areas that are more vascular (have more blood vessels), which helps in better detection and management of the disease. ^{1 2 3 4 5}

Is Ga 68 PSMA PET/CT imaging safe for humans?

Research indicates that Ga 68 PSMA PET/CT imaging is generally safe for humans. In a study with prostate cancer patients, no serious adverse events were reported, and only minor side effects like itching and a rash at the injection site occurred. ^{3 4 5 6 7}

How is the treatment Ga 68 PSMA PET/CT Imaging for Liver Cancer different from other treatments?

Ga 68 PSMA PET/CT is unique because it uses a radiotracer that targets prostate-specific membrane antigen (PSMA), which is not only present in prostate cancer but also in liver cancer, particularly in areas with high blood vessel growth. This imaging method is more effective than traditional PET/CT scans in detecting liver cancer lesions, especially those that are highly vascularized, making it a novel approach for diagnosing and managing liver cancer. ^{1 2 3 4 5}

Research Team

Nguyen H. Tran, MD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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

I am over 18 and willing to sign a consent form.

Have radiographically measurable disease by RECIST

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

(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]

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]

References

1. Netherlands 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. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

[68 Ga]Ga-Prostate-Specific Membrane Antigen PET/CT: a novel method for imaging patients with hepatocellular carcinoma. [2021]

3. Germany 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

68Ga-PSMA is a novel PET-CT tracer for imaging of hepatocellular carcinoma: A prospective pilot study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Occult Bone Metastases From Hepatocellular Carcinoma Detected on 68Ga-PMSA PET/CT. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

[Not Available]. [2021]

7. United States 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. [2022]