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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02978586
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate-specific Membrane Antigen Positive Tumors Prostate Cancer Breast Cancer Lung Cancer Device: [Ga-68]PSMA PET/MR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of [Ga-68]PSMA PET/MRI for the Assessment of PSMA-positive Tumors
Actual Study Start Date : March 12, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: [Ga-68]PSMA PET/MR
Up to 3 experimental PET/MRI scans will be performed to determine the level of [Ga-68]PSMA tumor uptake
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
Other Name: PET/MRI




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Test-retest reproducibility of quantification of MRI sequences (multi-parametric MRI) [ Time Frame: Up to 6 weeks after beginning treatment ]
    Morphologic imaging will be performed based on standard of care imaging protocols for anatomic detail and localization. Quantitative analysis will include Diffusion weighted imaging (DWI) and Dynamic contrast enhanced MRI (DCE-MRI)

  2. Ability of PET/MRI to measure changes in PET biomarker [Ga-68]PSMA) tumor uptake after initiation of therapy [ Time Frame: Up to 6 weeks after beginning treatment ]

    A region of interest (ROI) will be placed in tumor lesions on the digital PET images in order to obtain Standardized Uptake Values (SUV) and/or time activity curves (TACs).

    Relative and absolute differences in tumor SUVs between pre-treatment PET vs. PET after initiation of therapy will be calculated. These differences in [Ga-68]PSMA tumor uptake will be compared with treatment response at completion of therapy (prediction of treatment response).


  3. Changes in MR signal intensities after initiation of therapy [ Time Frame: Up to 6 weeks after beginning treatment ]
    Standard morphologic imaging will be obtained in a target area harboring tumor tissue before and after treatment. Quantitative parameters will be obtained in the respective techniques by drawing a region of interest (ROI) in the tumor lesions using dedicated post processing software and interactive workstations. Relative and absolute differences in tumor signal intensities and quantitative parameters will be calculated between pre-treatment PET vs. PET after initiation of therapy. These differences will be compared with treatment response at completion of therapy (prediction of treatment response) as assessed by standard of care imaging

  4. Comparison of early changes in PET biomarker ([Ga68]PSMA) tumor uptake with treatment response assessed at completion of therapy [ Time Frame: Up to 6 weeks after beginning treatment ]
    Relative and absolute differences in tumor SUVs between pre-treatment PET vs. PET after initiation of therapy will be compared with treatment response at completion of therapy.

  5. Comparison of changes in MRI signal intensities (multi-parametric MRI) with treatment response assessed at completion of therapy [ Time Frame: Up to 6 weeks after beginning treatment ]
    Relative and absolute differences in tumor MRI signal intensities and quantitative parameters as described above between pre-treatment PET vs. PET after initiation of therapy will be compared with treatment response at completion of therapy.

  6. Comparison of results from multi-parametric MR imaging with [Ga-68]PSMA tumor uptake [ Time Frame: Up to 6 weeks after beginning treatment ]
    Changes of tumor Ga68-PSMA uptake between baseline and during treatment will be compared with changes in MR multiparametric imaging (e.g. apparent diffusion coefficient (ADC) maps, MR perfusion parameters, changes in T2* maps, etc.). The ability of each PET and MR parameter will be assessed for the ability to predict treatment response.

  7. Assessment of combinations of quantitative PET and MRI metrics [ Time Frame: Up to 6 weeks after beginning treatment ]
    Investigators will assess combinations of quantitative PET and MRI metrics regarding their ability to characterize tumors and predict treatment response. Advanced feature extraction and pattern recognition methods will be used to find a combination of fused MRI and PET features that are correlated with disease signature.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978586


Contacts
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Contact: Norbert Avril, MD 216-286-3210 norbert.avril@uhhospitals.org

Locations
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United States, Ohio
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Norbert Avril    216-286-3210    Norbert.Avril@UHhospitals.org   
Principal Investigator: Norbert Avril         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Norbert Avril, MD University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02978586    
Other Study ID Numbers: CASE7Y16
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Case Comprehensive Cancer Center:
PSMA
PET/MRI
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases