Pilot Study of [18F]PARPi PET/MR Imaging in Patients With New and/or Suspected Recurrent Brain Tumors
PET and MRI Imaging of Brain Tumors Using [18F]PARPi
Sponsors
Source
Memorial Sloan Kettering Cancer Center
Oversight Info
Is Fda Regulated Drug
Yes
Is Fda Regulated Device
No
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
Overall Status
Recruiting
Start Date
2019-11-01
Completion Date
2020-11-01
Primary Completion Date
2020-11-01
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
SUVmax measurements |
Up to 24 weeks |
Number Of Groups
1
Enrollment
6
Conditions
Intervention
Intervention Type
Diagnostic Test
Intervention Name
Description
One PET/MR study (with up to 3 scan times) with [18F]PARPi
Arm Group Label
Participants with Brain Cancer
Intervention Type
Drug
Intervention Name
Description
Injection of <100ug of [18F]PARPi prior to 1 PET/MR
Arm Group Label
Participants with Brain Cancer
Eligibility
Study Pop
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.
Sampling Method
Non-Probability Sample
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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Robert Young, MD |
Principal Investigator |
Memorial Sloan Kettering Cancer Center |
Overall Contact
Location
Facility |
Status |
Contact |
|
Memorial Sloan Kettering Cancer Center New York New York 10065 United States |
Recruiting |
Last Name: Robert Young, MD Phone: 212-639-8196 |
Location Countries
Country
United States
Verification Date
2019-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Condition Browse
Arm Group
Arm Group Label
Participants with Brain Cancer
Description
Participants with new or suspected recurrent brain tumors
Firstreceived Results Date
N/A
Overall Contact Backup
Patient Data
Sharing Ipd
Yes
Ipd 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: [email protected]
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Prospective
Study First Submitted
November 19, 2019
Study First Submitted Qc
November 20, 2019
Study First Posted
November 21, 2019
Last Update Submitted
November 20, 2019
Last Update Submitted Qc
November 20, 2019
Last Update Posted
November 21, 2019
ClinicalTrials.gov processed this data on December 10, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.