Clinical trial NCT02978586: A Pilot Study of [Ga-68]PSMA PET/MRI for the Assessment of PSMA-positive Tumors
Official title: A Pilot Study of [Ga-68]PSMA PET/MRI for the Assessment of PSMA-positive Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate-specific Membrane Antigen Positive Tumors
Prostate Cancer
Breast Cancer
Lung Cancer
Keywords: PSMA
PET/MRI
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with tumors expressing PSMA including prostate cancer, breast cancer, lung cancer, renal cancer and other tumor types \[Ga-68\]PSMA PET/MRI known to express PSMA

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.

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)

Primary outcomes:
measure: Test-retest reproducibility of PET biomarker ([Ga68]-PSMA) uptake using PET/MRI
timeFrame: Up to 6 weeks after beginning treatment
Secondary outcomes:
measure: Test-retest reproducibility of quantification of MRI sequences (multi-parametric MRI)
timeFrame: Up to 6 weeks after beginning treatment
measure: Ability of PET/MRI to measure changes in PET biomarker [Ga-68]PSMA) tumor uptake after initiation of therapy
timeFrame: Up to 6 weeks after beginning treatment
measure: Changes in MR signal intensities after initiation of therapy
timeFrame: Up to 6 weeks after beginning treatment
measure: Comparison of early changes in PET biomarker ([Ga68]PSMA) tumor uptake with treatment response assessed at completion of therapy
timeFrame: Up to 6 weeks after beginning treatment
measure: Comparison of changes in MRI signal intensities (multi-parametric MRI) with treatment response assessed at completion of therapy
timeFrame: Up to 6 weeks after beginning treatment
measure: Comparison of results from multi-parametric MR imaging with [Ga-68]PSMA tumor uptake
timeFrame: Up to 6 weeks after beginning treatment
measure: Assessment of combinations of quantitative PET and MRI metrics
timeFrame: Up to 6 weeks after beginning treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Norbert Avril, MD
role: PRINCIPAL_INVESTIGATOR
References: