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

Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:March 12, 2018
End Date:September 2020
Contact:Norbert Avril, MD

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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.

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.

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

- 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

- 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
We found this trial at
11100 Euclid Avenue
Cleveland, Ohio 44106
Principal Investigator: Norbert Avril
Phone: 216-286-3210
Case Comprehensive Cancer Center The Case Comprehensive Cancer Center (Case CCC) based at Case Western...
Cleveland, OH
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