Ga-PSMA-PET/MRI for Liver Cirrhosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to enhance doctors' ability to assess liver cirrhosis using a special scan called Ga-PSMA PET/MRI. Researchers hope this scan will better measure blood flow and liver health without invasive tests. They also aim to determine if it can predict changes in the condition over time and its response to treatments. Individuals diagnosed with liver cirrhosis through imaging or clinical tests are suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the scan's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to advancements in non-invasive liver assessment.
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 the Ga-PSMA-PET/MRI protocol is safe for patients with liver cirrhosis?
Research has shown that [68Ga]Ga-PSMA-11 PET/MRI is generally easy for patients to tolerate and effective in diagnosing certain liver conditions. Studies have demonstrated that this imaging method accurately detects liver cancer spots. However, some participants have experienced health changes, such as unusual lab results, considered side effects and closely monitored. As this method remains in early testing for liver cirrhosis, comprehensive safety information may be limited. Nonetheless, current research suggests it could be a promising and relatively safe approach for assessing liver problems.12345
Why are researchers excited about this trial?
Researchers are excited about using [68Ga]Ga-PSMA-11 PET/MRI for assessing liver cirrhosis because it offers a new way to visualize and evaluate liver damage. Unlike standard imaging techniques like ultrasound or CT scans, this method combines PET and MRI to provide highly detailed images. This dual approach allows for better detection of liver abnormalities, potentially leading to more accurate diagnosis and monitoring of cirrhosis. By targeting specific molecular markers, it could also identify changes in the liver that other techniques might miss, offering a more comprehensive assessment.
What evidence suggests that Ga-PSMA PET/MRI is effective for liver cirrhosis?
Research has shown that a special imaging method called [68Ga]Ga-PSMA-11 PET/MRI might be very effective for liver conditions. In studies, this method demonstrated 97% accuracy in detecting liver problems, even in individuals with cirrhosis. This trial will evaluate [68Ga]Ga-PSMA-11 PET/MRI in patients with liver cirrhosis. It provides a clear view of liver function and appearance, aiding in the detection of nodules and predicting the progression of cirrhosis. This method also helps in understanding changes in blood flow in the liver, which is crucial for managing cirrhosis. Overall, [68Ga]Ga-PSMA-11 PET/MRI could serve as a powerful tool for assessing and monitoring liver health.35678
Who Is on the Research Team?
Onofrio Catalano
Principal Investigator
ocatalano@mgh.harvard.edu
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Imaging Session
Participants undergo Ga-PSMA-PET/MRI imaging to assess liver cirrhosis
Data Analysis
Analysis of PET/MRI images to evaluate liver function, fibrosis, and hemodynamics
Follow-up
Participants are monitored to assess the impact of imaging results on clinical management
What Are the Treatments Tested in This Trial?
Interventions
- [68Ga]Ga-PSMA-11 PET/MRI
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
55 Patients with liver cirrhosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Citations
Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment ...
Ga-PSMA PET/MRI may improve noninvasive and reproducible qualitative and quantitative assessment of liver function, structure, nodules and predict evolution of ...
68Ga-PSMA-11 PET/CT Improves Tumor Detection and ...
Consensus interpretation on a whole-liver level for the entire cohort and for patients with cirrhosis (28/40, 70%) resulted in an accuracy of 97% for both 68Ga ...
Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment ...
A total of fifty-five (55) patients with liver cirrhosis will be enrolled in this study to produce and validate dedicated Ga-PSMA-PET/MRI ...
Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment ...
A total of fifty-five (55) patients with liver cirrhosis will be enrolled in this study to produce and validate dedicated Ga-PSMA-PET/MRI acquisition protocols.
Can PSMA-Targeting Radiopharmaceuticals Be Useful for ...
Conclusions: The quantitative data provided demonstrate the high DR of PET/CT or PET/MRI with PSMA-targeting radiopharmaceuticals for HCC lesion detection.
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clinicaltrials.gov
clinicaltrials.gov/study/NCT06265272?term=AREA%5BConditionSearch%5D(%22Liver%20Cirrhosis%22)%20AND%20AREA%5BInterventionSearch%5D(%22Tannic%20acid%22)&rank=7Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment ...
An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a ...
Can PSMA-Targeting Radiopharmaceuticals Be Useful for ...
Overall, PSMA-targeting PET/CT or PET/MRI showed excellent diagnostic performance in detecting HCC lesions in all the studies included in the ...
68Ga-PSMA-11 PET/CT Improves Tumor Detection and ...
68 Ga-PSMA-11 PET demonstrated higher accuracy than CT in the detection of HCC metastases and was associated with a management change in about half the patient ...
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