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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new imaging method for detecting liver cancer. The method uses a special tracer that targets liver cancer cells to produce clearer images during scans. Participants will undergo PET/MRI or PET/CT scans to help researchers improve liver cancer diagnosis and management. Individuals diagnosed with liver cancer through imaging or biopsy, who have not yet received certain treatments, may qualify for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in liver cancer diagnosis.

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 prior data suggests that 68Ga-PSMA PET/MRI or PET/CT is safe for early detection of liver cancer?

Research shows that Gallium Ga 68 Gozetotide, a substance used in PET scans, is generally safe. Studies indicate that most patients tolerate it well, with very few side effects reported. Importantly, no serious side effects have been linked to its use. The FDA has already approved this substance for detecting prostate cancer, which supports its safety for imaging. Overall, the evidence suggests that it is safe based on the available data. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 68Ga-PSMA imaging for liver cancer because it offers a more precise way to detect cancerous lesions. Unlike standard imaging techniques like CT or MRI alone, this method combines a special radioactive compound, Gallium Ga 68 Gozetotide, with PET scans to specifically target and highlight cancer cells. This targeted approach can potentially result in earlier detection and more accurate assessment of the cancer, which could lead to better treatment planning and outcomes for patients.

What evidence suggests that 68Ga-PSMA PET/MRI or PET/CT is effective for early detection of liver cancer?

Research shows that 68Ga-PSMA PET scans can detect liver cancer more effectively. The tracer, 68Gallium-PSMA, binds to specific proteins on liver cancer cells, enhancing visibility. Studies have found that this method provides clearer images than CT scans alone. In this trial, participants will undergo PET scans combined with either MRI or CT scans, potentially improving image accuracy and aiding doctors in finding and treating liver cancer more successfully. ^{5 6 7 8 9}

Who Is on the Research Team?

Ajit H. Goenka, M.D.

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

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 might have surgery or a liver transplant.

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

I have not received any treatment for liver cancer.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

(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 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]

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]

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]

Citations

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

68Ga-PSMA-11 PET/CT Improves Tumor Detection and ... All patients with histopathologic verification had follow-up imaging performed. 68Ga-PSMA-11 PET versus CT accuracy for the liver lobes and distant metastases ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05176223?term=GALLIUM&viewType=Table&rank=10

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 ...

3. asco.org asco.org/abstracts-presentations/ABSTRACT366868

[68Ga]Ga-PSMA-11 PET baseline imaging as a prognostic ... In this sub-study, the association between imaging data from pre-enrollment 68Ga-PSMA-11 PET/CT scans of pts in the 177Lu-PSMA-617 group and clinical outcomes ...

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

Quantitative 68Ga-PSMA-11 PET and Clinical Outcomes in ... Visual 68 Ga-PSMA-11 PET/CT eligibility criteria helped identify participants with metastatic castration-resistant prostate cancer who benefitted from 177 Lu- ...

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.

6. 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 ...

7. 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 ...

9. 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 ...