- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04173104
PET and MRI Imaging of Brain Tumors Using [18F]PARPi
February 6, 2026 updated by: Memorial Sloan Kettering Cancer Center
Pilot Study of [18F]PARPi PET/MR Imaging in Patients With New and/or Suspected Recurrent Brain Tumors
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participants with Brain Cancer
Participants with new or suspected recurrent brain tumors
|
One PET/MR study (with up to 3 scan times) with [18F]PARPi
Injection of <100ug of [18F]PARPi prior to 1 PET/MR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SUVmax measurements
Time Frame: Up to 24 weeks
|
[18F]PARPi updtake in lesions will be quantified by standard SUVmax measurements from PET/MR scans
|
Up to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robert Young, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2019
Primary Completion (Actual)
February 5, 2026
Study Completion (Actual)
February 5, 2026
Study Registration Dates
First Submitted
November 19, 2019
First Submitted That Met QC Criteria
November 20, 2019
First Posted (Actual)
November 21, 2019
Study Record Updates
Last Update Posted (Actual)
February 9, 2026
Last Update Submitted That Met QC Criteria
February 6, 2026
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-311
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brain Cancer
-
University of Michigan Rogel Cancer CenterCompletedCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Xinhua Hospital, Shanghai Jiao Tong University...UnknownCancer | Metastatic Cancer | Metastatic Brain CancerChina
-
University of FloridaCompletedBrain Neoplasms | Brain Cancer | Brain Tumors | Seizure | Cancer of the Brain | Cancer of BrainUnited States
-
Eisai Inc.CompletedMetastatic Brain CancerUnited States
-
Fudan UniversityNot yet recruitingHER2-positive Breast Cancer | Breast Cancer With Brain Metastasis
-
Sunnybrook Health Sciences CentreActive, not recruitingBreast Cancer | Head and Neck Cancer | Gynecologic Cancer | Brain CancerCanada
-
InSightecActive, not recruitingGlioma | Metastatic Brain CancerCanada
-
Virginia Commonwealth UniversityUnited States Department of DefenseCompletedBrain Metastases, Adult | Cancer Metastatic to BrainUnited States
-
Memorial Sloan Kettering Cancer CenterCompleted
Clinical Trials on PET/MR with [18F]PARPi
-
The Affiliated Hospital of Qingdao UniversityRecruitingChronic Kidney Disease | Cardiac Magnetic Resonance | 18F-FAPIChina
-
University of EdinburghNHS LothianCompleted
-
Wuhan Union Hospital, ChinaRecruiting
-
St. Olavs HospitalNorwegian University of Science and Technology; Norwegian Cancer SocietyCompleted
-
Assistance Publique - Hôpitaux de ParisRecruitingMultiple Sclerosis | Inflammatory DiseaseFrance
-
University Health Network, TorontoRecruitingPulmonary HypertensionCanada
-
German Oncology Center, CyprusRecruiting
-
University GhentResearch Foundation Flanders; Special Research Fund, BelgiumCompletedHigh-grade Glioma of the BrainBelgium
-
University of Wisconsin, MadisonNational Center for Advancing Translational Sciences (NCATS)CompletedInvasive Breast CancerUnited States
-
Assistance Publique - Hôpitaux de ParisRecruiting