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

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: NCT04173104
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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

Condition or disease Intervention/treatment
Brain Tumor Brain Cancer Diagnostic Test: PET/MR with [18F]PARPi Drug: [18F]PARPi

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Study Type : Observational
Estimated Enrollment : 6 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of [18F]PARPi PET/MR Imaging in Patients With New and/or Suspected Recurrent Brain Tumors
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Group/Cohort Intervention/treatment
Participants with Brain Cancer
Participants with new or suspected recurrent brain tumors
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




Primary Outcome Measures :
  1. SUVmax measurements [ Time Frame: Up to 24 weeks ]
    [18F]PARPi updtake in lesions will be quantified by standard SUVmax measurements from PET/MR scans



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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): NCT04173104


Contacts
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Contact: Robert Young, MD 1212-639-8196 youngr@mskcc.org
Contact: Mark Dunphy, DO 1212-639-8131 dunphym@mskcc.org

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Robert Young, MD    212-639-8196      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Robert Young, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04173104    
Other Study ID Numbers: 19-311
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Brain cancer
18FPARPi
PET scan
MRI
Memorial Sloan Kettering Cancer Center
19-311
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases