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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04173104
Collaborator
(none)
8
1
48
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Study Details

Study Description

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 Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
8 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 :
Nov 1, 2019
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. SUVmax measurements [Up to 24 weeks]

    [18F]PARPi updtake in lesions will be quantified by standard SUVmax measurements from PET/MR scans

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Robert Young, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT04173104
Other Study ID Numbers:
  • 19-311
First Posted:
Nov 21, 2019
Last Update Posted:
Oct 22, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2021