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PET and MRI Imaging of Brain Tumors Using [18F]PARPi

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ClinicalTrials.gov Identifier: NCT04173104
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : October 22, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date November 19, 2019
First Posted Date November 21, 2019
Last Update Posted Date October 22, 2021
Actual Study Start Date November 1, 2019
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2019)
SUVmax measurements [ Time Frame: Up to 24 weeks ]
[18F]PARPi updtake in lesions will be quantified by standard SUVmax measurements from PET/MR scans
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PET and MRI Imaging of Brain Tumors Using [18F]PARPi
Official Title Pilot Study of [18F]PARPi PET/MR Imaging in Patients With New and/or Suspected Recurrent Brain Tumors
Brief Summary This study is to collect data about how 18FPARPi can be used together with PET/positron emission tomography and MRI/magnetic resonance imaging scans to take pictures of brain cancer
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Potential study participants will be identified by a member of the patient's treatment team at MSK. Women and men of all races and ethnic groups will be considered for study participation. Candidates must conform to all inclusion and exclusion criteria to be accepted into the study.
Condition
  • Brain Tumor
  • Brain Cancer
Intervention
  • Diagnostic Test: PET/MR with [18F]PARPi
    One PET/MR study (with up to 3 scan times) with [18F]PARPi
  • Drug: [18F]PARPi
    Injection of <100ug of [18F]PARPi prior to 1 PET/MR
Study Groups/Cohorts Participants with Brain Cancer
Participants with new or suspected recurrent brain tumors
Interventions:
  • Diagnostic Test: PET/MR with [18F]PARPi
  • Drug: [18F]PARPi
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 2, 2020)
8
Original Estimated Enrollment
 (submitted: November 20, 2019)
6
Estimated Study Completion Date November 2023
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with new or suspected recurrent brain tumors (including suspected recurrent brain tumors showing growth from any preceding scan)
  • Age >/= 18 years
  • Minimum at least one brain lesion size >/= 1.5cm diameter
  • Scheduled to undergo treatment at MSK
  • Willingness to sign informed consent
  • Able to receive intravenous gadolinium contrast per MSK Department of Radiology guidelines

Exclusion Criteria:

  • Any contraindication to 3T MRI (PET/MR scanner is 4.0 Tesla)
  • Pregnancy or breast-feeding women
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Robert Young, MD 1212-639-8196 youngr@mskcc.org
Contact: Mark Dunphy, DO 1212-639-8131 dunphym@mskcc.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04173104
Other Study ID Numbers 19-311
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Robert Young, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date October 2021