Ga 68 PSMA PET/CT Imaging for Liver Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Nguyen H. Tran, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Breastfeeding, Weight/size limits

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

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.

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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.

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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.

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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

Trial 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)

Participant Groups

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.

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic in Rochester Rochester, MN

Who Is Running the Clinical Trial?

Mayo Clinic Lead Sponsor

National Cancer Institute (NCI) Collaborator

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] Label="CONTEXT"> 68Gallium prostate-specific membrane antigen (PSMA) ligand 68Ga-HBED-CC-PSMA (68Ga-PSMA) is a promising radiotracer for positron emission tomography (PET)/computed tomography (CT) of prostate cancer.

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] Label="PURPOSE">Prostate-specific membrane antigen (PSMA) is not only highly expressed on the surface prostate cancer cells but is also elevated during angiogenesis in other cancer cell types, including hepatocellular carcinoma (HCC). This study aimed to evaluate the feasibility of using PET/CT imaging with [68Ga]Ga-PSMA-11 in HCC and its impact on patient management.

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] Prostate-specific membrane antigen (PSMA) is a glycosylated type-II transmembrane protein highly expressed in certain tumor cells. To the best of our knowledge, this is the first case reported of an isolated well-differentiated hepatocellular carcinoma (HCC) strongly suspected on gallium-68 (68Ga)-PSMA positron emission tomography/computed tomography (PET/CT), which was not well characterized both on magnetic resonance imaging (MRI) liver with Primovist as well as fluorine-18 (18F)-choline PET/CT. Our patient had previous prostate cancer and previously was imaged using 18F-choline PET/CT. The last scan showed an indeterminate segment VII hypodensity which was not significantly choline-avid. The lesion was initially stable on serial MRI scans but then showed growth from 1.0 to 1.5 cm. 68Ga-PSMA PET/CT was performed. The lesion was intensely tracer-avid. This was surgically excised and histology confirmed the presence of well-differentiated HCC. Well-differentiated HCC can be optimally imaged using 68Ga-PSMA PET/CT and further prospective studies are needed to look into the potential of this imaging modality.

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] Background:68Ga-Prostate Specific Membrane Antigen (68Ga-PSMA), a positron emission tomography (PET) tracer that was recently introduce for imaging of prostate cancer, may accumulate in other solid tumors including Hepatocellular Carcinoma (HCC). The aim of the study was to assess the potential role of 68Ga-PSMA PET-Computed Tomography (CT) for imaging of HCC. Material and Methods: A prospective pilot study in seven patients with HCC with 41 liver lesions: 37 suspected malignant lesions (tumor lesions) and 4 regenerative nodules. For each liver lesion, uptake of 68Ga-PSMA and 18F-FDG uptake were measured [standard uptake value (SUV) and lesion-to-liver background ratios (TBR-SUV)], and correlated with dynamic characteristics (HU and TBR-HU) obtained on contrast enhanced CT data. Immunohistochemistry staining of PSMA in the tumor tissue was analyzed in samples obtained from 5 patients with HCC and compared to control samples from 3 patients with prostate cancer. Results: Thirty-six of the 37 tumor lesions and none of the regenerative nodules showed increased 68Ga-PSMA uptake while only 10 lesions were 18F-FDG avid. Based on contrast enhancement, tumor lesions were categorized into 27 homogeneously enhancing lesions, nine lesions with "mosaic" enhancement composed of enhancing and non-enhancing regions in the same lesion and a single non-enhancing lesion, the latter being the only non-68Ga-PSMA avid lesion. Using the Mann-Whitney test, 68Ga-PSMA uptake was found significantly higher in enhancing tumor areas compared to non-enhancing areas and in contrast, 18F-FDG uptake was higher in non-enhancing areas, P<0.001 for both. 68Ga-PSMA uptake (TBR SUVmax) was found to correlate with vascularity (TBR-HU) (Spearman r=0.866, p<0.001). Immunohistochemistry showed intense intra-tumoral microvessel staining for PSMA in HCC, in contrast with cytoplasmic and membranous staining, mainly in the luminal border, in prostate cancer samples. In two of the study patients 68Ga-PSMA PET-CT identified unexpected extrahepatic metastases. Four regenerative liver nodules showed no increased uptake of either of the PET tracers. Conclusion:68Ga-PSMA PET-CT is superior to 18F-FDG PET-CT in imaging patients with HCC. HCC lesions are more commonly hypervascular taking up 68Ga-PSMA in tumoral micro-vessels. 68Ga-PSMA PET-CT is a potential novel modality for imaging patients with HCC.

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

Occult Bone Metastases From Hepatocellular Carcinoma Detected on 68Ga-PMSA PET/CT. [2023] 68Ga-PSMA is an excellent radiotracer for both staging and detection of recurrence in prostate cancer, but it can also be useful in other solid tumors due to tumor-associated angiogenic factors and endothelial cell sprouting. We report a case of an 82-year-old man with hepatocellular carcinoma who presented with rising tumor marker but stable CT findings 6 months after transarterial chemoembolization. 68Ga-PSMA PET/CT showed high PSMA-expressing hyperneovascular hepatic lesions (primary tumor), additional multifocal hepatic lesions, and with unexpected multiple bone metastases. 68Ga-PSMA expression in hepatocellular carcinoma can influence patient management and potentially guide radionuclide legend therapy.

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

[Not Available]. [2021] (68)Gallium (Ga)-PSMA PET/CT (PSMA stands for "prostate-specific membrane antigen") is a new diagnostic tool for patients with prostate cancer or with prostate cancer metastases. PET/CT is a combination scan which uses the physiological information of the PET scan and the anatomic information of the CT scan. The radioligand (68)Ga-PSMA is a radioactively labelled peptide that binds to the membrane protein PSMA. Prostate cancer cells in the primary tumour and in metastases express increased levels of PSMA in the plasma membrane. A number of studies have shown that (68)Ga-PSMA PET/CT is sensitive in detecting primary prostate cancer and metastases in lymph nodes and bone. In the same patient, (68)Ga-PSMA PET/CT detects more metastases in an earlier phase, i.e. at a lower PSA level, than fluorine-18 choline PET/CT. Furthermore, the (68)Ga-PSMA can be produced in the investigating hospital with a gallium generator. The expectation is that the use of (68)Ga-PSMA PET/CT will increase to a major extent over the coming years in patients with prostate cancer.

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] Objectives: To assess the safety and clinical impact of a novel, kit-based formulation of 68Ga-THP PSMA positron emission tomography/computed tomography (PET/CT) when used to guide the management of patients with prostate cancer (PCa). Methods: Patients were prospectively recruited in to one of: Group A: high-risk untreated prostate cancer; Gleason score >4+3, or PSA >20 ng/mL or clinical stage >T2c. Group B: biochemical recurrence (BCR) and eligible for salvage treatment after radical prostatectomy with two consecutive rises in prostate specific antigen (PSA) with a three month interval in between reads and final PSA >0.1 ng/mL or a PSA level >0.5 ng/mL. Group C: BCR with radical curative radiotherapy or brachytherapy at least three months prior to enrolment, and an increase in PSA level >2.0 ng/mL above the nadir level after radiotherapy or brachytherapy. Patients underwent evaluation with PET/CT 60 minutes following intravenous administration of 160±30 MBq of 68Ga-THP PSMA. Safety was assessed by means including vital signs, cardiovascular profile, serum haematology, biochemistry, urinalysis, PSA, and Adverse Events (AEs). A change in management was reported when the predefined clinical management of the patient altered as a result of 68Ga-THP PSMA PET/CT findings. Results: Forty-nine patients were evaluated with PET/CT; 20 in Group A, 21 in Group B and 8 in Group C. No patients experienced serious AEs discontinued the study due to AEs, or died during the study. Two patients had Treatment Emergent AEs attributed to 68Ga-THP-PSMA (pruritus in one patient and intravenous catheter site rash in another). Management change secondary to PET/CT occurred in 42.9% of all patients; 30% in Group A, 42.9% in Group B and 75% in Group C. Conclusion: 68Ga-THP PSMA was safe to use with no serious AE and no AE resulting in withdrawal from the study. 68Ga-THP PSMA PET/CT changed the management of patients in 42.9% of the study population, comparable to studies using other PSMA tracers. These data form the basis of a planned Phase III study of 68Ga-THP PSMA in patients with prostate cancer.