NCT02978586

A Pilot Study of [Ga-68]PSMA PET/MRI for the Assessment of PSMA-positive Tumors

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate-specific Membrane Antigen Positive Tumors
• Prostate Cancer
• Breast Cancer
• Lung Cancer

Interventions

Type	Name	Description
DEVICE	[Ga-68]PSMA PET/MR	All participants will undergo at least 1 baseline \[Ga-68\]PSMA PET/MR. If participants test positive for \[Ga-68\]PSMA tumor uptake, they will under up to 2 additional scans

Timeline

• Start date: 2018-03-14
• Primary completion: 2019-10-25
• Completion: 2019-10-25
• First posted: 2016-12-01
• Last updated: 2021-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study