A Pilot Study of [Ga-68]PSMA PET/MRI for the Assessment of PSMA-positive Tumors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate-specific Membrane Antigen Positive Tumors
- Sponsor
- Case Comprehensive Cancer Center
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Test-retest reproducibility of PET biomarker ([Ga68]-PSMA) uptake using PET/MRI
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to see if positron emission tomography/ magnetic resonance imaging (PET/MRI) can be used to monitor the effectiveness of cancer treatment using an investigational radioactive drug called [Ga-68]PSMA.
Detailed Description
Primary Objective The primary objective of this pilot imaging study is to determine the feasibility of using positron emission tomography/ magnetic resonance (PET/MR) with \[Ga-68\] prostate-specific membrane antigen (PSMA) for staging and treatment monitoring of PSMA expressing tumors. \[Ga-68\]PSMA PET/MR findings will be compared with standard of care imaging, patient follow up, and histopathology if available. \[Ga-68\]PSMA PET/MR will not be used to change the patients' treatment plan. Investigators will assess PET/MR test-retest reproducibility and compare baseline \[Ga-68\]PSMA PET/MR with PET/MR after initiation (within 2-6 weeks) of therapy and evaluate if \[Ga-68\]PSMA is a suitable biomarker for treatment monitoring and assessment of early treatment response. Secondary Objectives * To compare early changes in PET biomarker (\[Ga-68\]PSMA) tumor uptake with treatment response assessed at completion of therapy (prediction of treatment response). * To compare changes in MRI signal intensities (multi-parametric MRI) with treatment response assessed at completion of therapy. * To compare results from multi-parametric MR imaging with \[Ga-68\]PSMA uptake. * To assess combinations of quantitative PET and MRI metrics. Study Design Patients, who enroll in this study, will undergo a baseline \[Ga-68\]PSMA PET/MR to assess the level of \[Ga-68\]PSMA tumor uptake. Patients with positive \[Ga-68\]PSMA tumor uptake (defined as \[Ga-68\]PSMA uptake twice the background activity) who are receiving systemic therapy will undergo a further \[Ga-68\]PSMA PET/MR 2-6 weeks after start of treatment. Patients with positive \[Ga-68\]PSMA tumor uptake will also be offered to participate in a test- retest study with a 2nd \[Ga-68\]PSMA PET/MR prior to treatment. Patients will therefore undergo a maximum of three \[Ga-68\]PSMA PET/MR imaging procedures. The first two test-retest Ga-PSMA-PET/MRI will be performed on separate days to allow for radioactive decay. There will be no other (e.g. clinically indicated) PET scan performed on the same day of \[Ga-68\]PSMA-PET/MRI.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with PSMA-positive tumors including prostate cancer, breast cancer, lung cancer, and other tumor types know to express PSMA
- •Patients able to tolerate PET/MRI scans
- •Informed consent must be given and signed
Exclusion Criteria
- •Subjects who do not meet the above mentioned inclusion criteria
- •Subjects who refuse to give and/or sign the informed consent
- •Patients who have a history of serious adverse events related to a previous MRI or PET/CT
- •Patients who are unable to undergo MRI scanning due to exclusion by institutional MRI restriction policies as mentioned in the standard institutional MRI informed consent form
- •Patients who are currently pregnant or breast feeding. A pregnancy test within 72 hours of the first PET/MRI will be performed.
- •Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks.
- •Renal insufficiency: elevated Creatinine and/or Glomerular Filtration Rate (GFR)\<40ml/min/1.7sqm (exclusion criterion only for contrast enhanced MRI)
- •Patients with a known allergy against any component of the contrast enhancing MR agent will not receive MR contrast agents. (exclusion criterion only for contrast enhanced MRI)
Outcomes
Primary Outcomes
Test-retest reproducibility of PET biomarker ([Ga68]-PSMA) uptake using PET/MRI
Time Frame: Up to 6 weeks after beginning treatment
The outcome measure for the statistical analysis of the test-retest reproducibility will be concordance analysis of standard uptake values (SUVs) between the 2 baseline scans
Secondary Outcomes
- Ability of PET/MRI to measure changes in PET biomarker [Ga-68]PSMA) tumor uptake after initiation of therapy(Up to 6 weeks after beginning treatment)
- Comparison of changes in MRI signal intensities (multi-parametric MRI) with treatment response assessed at completion of therapy(Up to 6 weeks after beginning treatment)
- Comparison of results from multi-parametric MR imaging with [Ga-68]PSMA tumor uptake(Up to 6 weeks after beginning treatment)
- Test-retest reproducibility of quantification of MRI sequences (multi-parametric MRI)(Up to 6 weeks after beginning treatment)
- Changes in MR signal intensities after initiation of therapy(Up to 6 weeks after beginning treatment)
- Comparison of early changes in PET biomarker ([Ga68]PSMA) tumor uptake with treatment response assessed at completion of therapy(Up to 6 weeks after beginning treatment)
- Assessment of combinations of quantitative PET and MRI metrics(Up to 6 weeks after beginning treatment)