NCT04173104

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Nov 2019

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2026

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2025

Enrollment Period

6.3 years

First QC Date

November 19, 2019

Last Update Submit

February 6, 2026

Conditions

Keywords

Brain cancer18FPARPiPET scanMRIMemorial Sloan Kettering Cancer Center19-311

Outcome Measures

Primary Outcomes (1)

  • SUVmax measurements

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

    Up to 24 weeks

Study Arms (1)

Participants with Brain Cancer

EXPERIMENTAL

Participants with new or suspected recurrent brain tumors

Diagnostic Test: PET/MR with [18F]PARPiDrug: [18F]PARPi

Interventions

PET/MR with [18F]PARPiDIAGNOSTIC_TEST

One PET/MR study (with up to 3 scan times) with \[18F\]PARPi

Participants with Brain Cancer

Injection of \<100ug of \[18F\]PARPi prior to 1 PET/MR

Participants with Brain Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any contraindication to 3T MRI (PET/MR scanner is 4.0 Tesla)
  • Pregnancy or breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Robert Young, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2019

First Posted

November 21, 2019

Study Start

November 1, 2019

Primary Completion

February 5, 2026

Study Completion

February 5, 2026

Last Updated

February 9, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

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.

Locations