- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05176223
68Ga PSMA PET Imaging for the Treatment of Advanced Liver Cancer
Optimizing Outcomes of Patients With Advanced HCC Undergoing Immunotherapy Through Novel 68Ga PSMA PET Imaging
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To test the performance of novel biomarkers derived from PSMA PET/computed tomography (CT) to measure response compared to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, in advanced hepatocellular carcinoma (HCC) patients treated with immunotherapy.
II. To identify precision imaging biomarkers that can predict response of HCC to novel immunotherapy.
OUTLINE:
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.
After completion of study treatment, patients are followed-up every 6 months for 3 years.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
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Principal Investigator:
- Nguyen H. Tran, M.D.
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Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient with pathologically confirmed HCC not amenable to curative resection, transplantation or ablative therapies
- Have radiographically measurable disease by RECIST
- Eligible for atezolizumab/bevacizumab front line therapy
- Male or female with age greater than 18 years, with the capacity and willingness to provide written informed consent
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (68GA PSMA PET/CT)
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.
|
Undergo 68Ga PSMA PET/CT
Other Names:
Undergo 68Ga PSMA PET/CT
Other Names:
Undergo 68Ga PSMA PET/CT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival (PFS)
Time Frame: At 6 months
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Will be calculated among PSMA PET/CT positive patients using Kaplan-Meier method with corresponding confidence interval calculated using Greenwood's formula.
In PSMA negative patients, will explore the potential prognostic effect of PSMA status on PFS using Cox proportional hazard model with PSMA PET/CT status (positive versus negative) as the main variable of interest while adjusting for other potential confounders.
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At 6 months
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Time to treatment response
Time Frame: Time from study registration to complete response/partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and per PSMA positron emission tomography (PET)/computed tomography (CT), assessed up to 12 cycles of treatment or 36 weeks
|
Time to response, per RECIST 1.1 and per PSMA PET/CT, will be correlated to each other using Cox proportional hazard model with response per RECIST 1.1 as the dependent variable and the time to response per PSMA PET/CT will be included in the model as a time-varying covariate.
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Time from study registration to complete response/partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and per PSMA positron emission tomography (PET)/computed tomography (CT), assessed up to 12 cycles of treatment or 36 weeks
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Time to progression
Time Frame: Time from study registration to disease progression per RECIST 1.1 and per PSMA PET/CT, assessed up to 3 years
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RECIST 1.1 and PSMA PET/CT will be correlated to each other using Cox proportional hazard model with response per RECIST 1.1 as the dependent varible and the time to response per PSMA PET/CT will be included in the model as a time-vaying covariate.
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Time from study registration to disease progression per RECIST 1.1 and per PSMA PET/CT, assessed up to 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nguyen H Tran, Mayo Clinic in Rochester
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Anticoagulants
- Chelating Agents
- Sequestering Agents
- Calcium Chelating Agents
- Edetic Acid
- Gallium 68 PSMA-11
Other Study ID Numbers
- 21-007799
- NCI-2021-12377 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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