68Ga-PSMA Imaging for Liver Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Claustrophobia, Kidney issues, others

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

Compensation: Varies

Number of Visits: 1

52 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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

The trial information 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 68Ga-PSMA Imaging for Liver Cancer?

Research shows that 68Ga-PSMA PET-CT is effective in imaging liver cancer (hepatocellular carcinoma) by highlighting tumor areas more clearly than other imaging methods, like 18F-FDG PET-CT. This imaging technique can help identify liver cancer lesions and even detect unexpected metastases, making it a promising tool for managing liver cancer. ^{1 2 3 4 5}

Is 68Ga-PSMA imaging safe for humans?

68Ga-PSMA imaging has been used safely in humans, with no serious adverse events reported in studies. Some minor side effects like itching and rash at the injection site have been noted, but no participants had to stop the study due to these effects. ^{1 6 7 8 9}

How does 68Ga-PSMA imaging differ from other treatments for liver cancer?

68Ga-PSMA imaging is unique because it uses a special tracer to highlight liver cancer cells in PET/CT scans, making it easier to detect and assess tumors compared to traditional imaging methods. This approach is particularly effective for identifying hypervascular liver cancer lesions, which may not be as visible with other imaging techniques. ^{1 2 4 5 10}

Research Team

Ajit H. Goenka, M.D.

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

This trial is for adults over 18 with confirmed liver cancer (Hepatocellular Carcinoma) who haven't had treatment yet. It's open to those who can consent and might have surgery or a transplant. People with high bilirubin levels, severe kidney issues, pregnancy, claustrophobia, allergies to certain MRI contrasts, or implanted devices like pacemakers are excluded.

Inclusion Criteria

I am over 18 and willing to give written consent.

I might have surgery or a liver transplant.

My liver cancer diagnosis was confirmed by a high-level scan or biopsy.

Exclusion Criteria

You have implanted devices with magnets in your body.

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

You have had an allergic reaction to Eovist or Gadavist in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Participants receive 68Ga-PSMA intravenously and undergo PET/MRI or PET/CT imaging

1 day

1 visit (in-person)

Follow-up

Participants are monitored for diagnostic performance and biomarker correlation

6 weeks

Treatment Details

Interventions

• Computed Tomography
• Gallium Ga 68 Gozetotide
• Magnetic Resonance Imaging
• Positron Emission Tomography

Trial Overview The study tests if a radioactive tracer called 68Ga-PSMA combined with PET/MRI or PET/CT scans improves early detection of liver cancer. The tracer targets cancer cells and the scans create detailed images of organs and tissues to help diagnose and manage liver cancer.

Participant Groups

Group I: Diagnostic (68Ga-PSMA PET/MRI or PET/CT) Experimental Treatment 4 Interventions

Patients receive 68Ga-PSMA IV over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

99mTechnetium labeled PSMA SPECT-CT imaging is a cost-effective and simpler alternative to Gallium-68 PSMA PET-CT for diagnosing prostate cancer, including detecting primary tumors and metastases.

The study presents a case showing the use of 99mTc-PSMA imaging before therapy and 177Lu-PSMA imaging after therapy, highlighting the potential for effective monitoring of treatment response in prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tc-99m PSMA and Lu-177 PSMA Theranostic Pair in a Patient of Metastatic Castration Resistant Prostate Cancer. Sheikh, N., Younis, MN., Mumtaz, M., et al.[2022]

The study highlights the imaging characteristics of a metastatic superscan using gallium-68-PSMA PET/CT, a new radiotracer being tested for prostate cancer imaging.

This imaging technique was used to assess a patient with extensive bone metastases, indicating its potential role in evaluating candidates for targeted therapies like Lu-177-PSMA treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metastatic superscan in prostate carcinoma on gallium-68-prostate-specific membrane antigen positron emission tomography/computed tomography scan. Agarwal, KK., Tripathi, M., Kumar, R., et al.[2020]

68Ga-PSMA-PET/CT imaging is highly effective for diagnosing and staging prostate cancer, outperforming traditional CT and MR imaging in detecting metastatic disease, which is crucial for determining treatment strategies.

This imaging technique not only aids in accurate diagnosis but also enhances treatment planning by guiding biopsies and surgeries, and it can identify patients suitable for targeted therapies like Lutetium-177 and Actinium-225 PSMA, which are used to treat prostate cancer metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Gallium-68 PSMA PET/CT Imaging in the Management of Prostate Cancer. Lenzo, NP., Meyrick, D., Turner, JH.[2020]

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]

The preparation of [(68)Ga]PSMA-11 for PET-CT imaging in prostate cancer patients resulted in consistently high radiochemical yields of 93.19%±3.76%, with over 200 batches produced and no batch failures reported.

The radiopharmaceutical demonstrated high radiochemical purity (>99%) and was well-tolerated by over 300 patients, with no adverse reactions observed, indicating its safety and efficacy for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation of [(68)Ga]PSMA-11 for PET-CT imaging using a manual synthesis module and organic matrix based (68)Ge/(68)Ga generator. Nanabala, R., Anees, MK., Sasikumar, A., et al.[2021]

The imaging agent [68Ga]Ga-PSMA-093 shows excellent blood clearance and rapid tumor uptake, making it effective for detecting prostate cancer lesions, as confirmed by clinical studies.

Different sources of 68Ge/68Ga generators can be used to reliably produce [68Ga]Ga-PSMA-093 with high yields, ensuring the availability of this imaging tracer for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kit-based preparation of [68Ga]Ga-P16-093 (PSMA-093) using different commercial 68Ge/68Ga generators. Hong, H., Wang, G., Ploessl, K., et al.[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]

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]

A systematic review of 16 studies involving 1309 patients found that 68Ga-PSMA PET scans are highly effective in detecting metastatic prostate cancer, with a 76% positivity rate in patients with biochemical recurrence, especially as pre-PET PSA levels increase.

The overall sensitivity and specificity of 68Ga-PSMA PET were found to be 86% and 80% respectively, indicating that this imaging technique is more reliable than traditional choline-based PET imaging for assessing prostate cancer spread.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensitivity, Specificity, and Predictors of Positive 68Ga-Prostate-specific Membrane Antigen Positron Emission Tomography in Advanced Prostate Cancer: A Systematic Review and Meta-analysis. Perera, M., Papa, N., Christidis, D., et al.[2022]

References

1. Pakistan pubmed.ncbi.nlm.nih.gov

Tc-99m PSMA and Lu-177 PSMA Theranostic Pair in a Patient of Metastatic Castration Resistant Prostate Cancer. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Metastatic superscan in prostate carcinoma on gallium-68-prostate-specific membrane antigen positron emission tomography/computed tomography scan. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Review of Gallium-68 PSMA PET/CT Imaging in the Management of Prostate Cancer. [2020]

4. 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]

5. 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]

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

Preparation of [(68)Ga]PSMA-11 for PET-CT imaging using a manual synthesis module and organic matrix based (68)Ge/(68)Ga generator. [2021]

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

Kit-based preparation of [68Ga]Ga-P16-093 (PSMA-093) using different commercial 68Ge/68Ga generators. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

[Not Available]. [2021]

9. 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]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Sensitivity, Specificity, and Predictors of Positive 68Ga-Prostate-specific Membrane Antigen Positron Emission Tomography in Advanced Prostate Cancer: A Systematic Review and Meta-analysis. [2022]