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

NCT02978586

Description:

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.

Related Conditions:
  • Breast Carcinoma
  • Lung Carcinoma
  • Malignant Solid Tumor
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CASE7Y16
  • NCT ID: NCT02978586

Conditions

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

Purpose

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) I&T 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.
    

Trial Arms

NameTypeDescriptionInterventions
[Ga-68]PSMA PET/MRExperimentalUp to 3 experimental PET/MRI scans will be performed to determine the level of [Ga-68]PSMA tumor uptake

    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)
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Test-retest reproducibility of PET biomarker ([Ga68]-PSMA) uptake using PET/MRI
    Time Frame:Up to 6 weeks after beginning treatment
    Safety Issue:
    Description: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

    Measure:Test-retest reproducibility of quantification of MRI sequences (multi-parametric MRI)
    Time Frame:Up to 6 weeks after beginning treatment
    Safety Issue:
    Description: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)
    Measure: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
    Safety Issue:
    Description: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).
    Measure:Changes in MR signal intensities after initiation of therapy
    Time Frame:Up to 6 weeks after beginning treatment
    Safety Issue:
    Description: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
    Measure: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
    Safety Issue:
    Description: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.
    Measure: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
    Safety Issue:
    Description: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.
    Measure:Comparison of results from multi-parametric MR imaging with [Ga-68]PSMA tumor uptake
    Time Frame:Up to 6 weeks after beginning treatment
    Safety Issue:
    Description: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.
    Measure:Assessment of combinations of quantitative PET and MRI metrics
    Time Frame:Up to 6 weeks after beginning treatment
    Safety Issue:
    Description: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.

    Details

    Phase:Early Phase 1
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:Case Comprehensive Cancer Center

    Trial Keywords

    • PSMA
    • PET/MRI

    Last Updated

    November 28, 2016