N/A
N=30
Imaging Brain Tumors With FACBC and Methionine
Brain Cancer · CNS Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00597246 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Maximum Standardized Uptake Value of 3-[18F]-FACBC — 4.5 SUVmax
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FACBC, Methionine (Drug); PET Scan (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Standardized Uptake Value of 3-[18F]-FACBC |
4.5 | — |
| SECONDARY Rate of 18F-Fluciclovine Transport (k1) Into Tumors |
0.14 | — |
Summary
This research protocol makes pictures of brain tumors. The pictures are made with a positron emission tomography (PET) scanner. PET scans use radioactivity to "see" cancer cells. We are using a new kind of PET scan. The new PET scan is called [18F]-FACBC PET. We will compare this to the standard PET scan. The standard PET scan is called [11C]-methionine PET.
We expect these pictures will give us information about your tumor. We also hope to collect information about the amount of radioactivity exposure. We will measure radioactivity exposure to your tumor, brain and other organs. The research study results will be used to support the submission of an investigational new drug (IND) application to the Food and Drug Administration (FDA).
Eligibility Criteria
Inclusion Criteria
- Registered patient at MSKCC.
- Child-bearing age females must be non-pregnant, non-lactating, and must be using adequate contraception or surgically sterile.
- Karnofsky score of 60 or greater.
- Children that can sit still for 60-90 minutes, without sedation, will be included in this protocol.
Exclusion Criteria
- Patient cannot tolerate lying still for 90 minute sessions in the PET tomograph.
Data sourced from ClinicalTrials.gov (NCT00597246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.