Brain TumorEarly Phase 1NCT04173104
PET and MRI Imaging of Brain Tumors Using [18F]PARPi
A Early Phase 1 study testing PET/MR with [18F]PARPi and [18F]PARPi in people with Brain Tumor and Brain Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Brain Cancer
- What is being tested?
- PET/MR with [18F]PARPi and [18F]PARPi
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 5 Feb 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any contraindication to 3T MRI (PET/MR scanner is 4.0 Tesla)
- Pregnancy or breast-feeding women
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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
- Conditions
- Brain Tumor, Brain Cancer
- Being tested
- PET/MR with [18F]PARPi, [18F]PARPi
- Keywords
- Brain cancer, 18FPARPi, PET scan, MRI, Memorial Sloan Kettering Cancer Center, 19-311
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MR with [18F]PARPiDiagnostic test
One PET/MR study (with up to 3 scan times) with [18F]PARPi
[18F]PARPiDrug
Injection of <100ug of [18F]PARPi prior to 1 PET/MR
| Study group | Role | What they receive |
|---|---|---|
| Participants with Brain Cancer | Experimental | Participants with new or suspected recurrent brain tumors Receives: Diagnostic Test: PET/MR with [18F]PARPi; Drug: [18F]PARPi |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax measurements
[18F]PARPi updtake in lesions will be quantified by standard SUVmax measurements from PET/MR scans
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Nov 2019
- Primary completion5 Feb 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Young, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173104
- Sponsor's protocol ID
- 19-311
- Status last verified
- Feb 2025
- First submitted
- 19 Nov 2019
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of [18F]PARPi PET/MR Imaging in Patients With New and/or Suspected Recurrent Brain Tumors
- ClinicalTrials.gov ID
- NCT04173104
- Acronym / sponsor ID
- 19-311
- Conditions
- Brain Tumor, Brain Cancer
- Keywords
- Brain cancer, 18FPARPi, PET scan, MRI, Memorial Sloan Kettering Cancer Center, 19-311
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Brain Cancer | Experimental | Diagnostic Test: PET/MR with [18F]PARPi, Drug: [18F]PARPiParticipants with new or suspected recurrent brain tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Any contraindication to 3T MRI (PET/MR scanner is 4.0 Tesla)
- Pregnancy or breast-feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/MR with [18F]PARPiOne PET/MR study (with up to 3 scan times) with [18F]PARPi | Diagnostic test | Participants with Brain Cancer |
| [18F]PARPiInjection of <100ug of [18F]PARPi prior to 1 PET/MR | Drug | Participants with Brain Cancer |
Primary outcome
SUVmax measurements
Time frame: Up to 24 weeks
[18F]PARPi updtake in lesions will be quantified by standard SUVmax measurements from PET/MR scans
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Young, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PET/MR with [18F]PARPi and [18F]PARPi in people with Brain Tumor and Brain Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmax measurements (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.