N/A
N=13
[18F] FACBC and [18F] FLT PET Imaging in Central Nervous System Tumors
Brain Cancer · Gliomas
Bottom Line
View on ClinicalTrials.gov: NCT00832598 ↗Enrolled (actual)
13
Serious AEs
30.8%
Results posted
Apr 2018
Primary outcome: Primary: Determine & Comp Biodistribution, Clearance, & Dosimetry of [18F]FACBC & [18F]FLT Tissue/Organs w/i the Field of View of the Dynamic PET Imag Studies prior-to & During Anti-AKT &/or Anti-VEGF Directed Therapies Alone or in Combin With Radia for Glioma.
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- [18F]FACBC PET and [18F]FLT PET imaging (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine & Comp Biodistribution, Clearance, & Dosimetry of [18F]FACBC & [18F]FLT Tissue/Organs w/i the Field of View of the Dynamic PET Imag Studies prior-to & During Anti-AKT &/or Anti-VEGF Directed Therapies Alone or in Combin With Radia for Glioma. |
— | — |
| SECONDARY Compare [18F]FACBC PET & [18F]FLT PET Results With MRI Imaging in Patients With Recurrent Gliomas (n=30). |
— | — |
| SECONDARY Explore if [18F]FACBC PET and [18F]FLT PET Imaging Can be Related to Molecular Markers (AKT, VEGFR, and Related Signaling/Biologic Changes by Immunohistochemistry and/or Analysis of Flash Frozen Tissue) |
— | — |
Summary
The purpose of this study is to help us understand gliomas, one type of brain tumor. This research protocol makes pictures of gliomas. We will take pictures of the glioma before and after treatment. The pictures are made with a positron emission tomography (PET) scanner. PET scans use radioactive markers to "see" cancer cells. We plan to use two different radioactive markers, [18F]FACBC and [18F]FLT, to "see" if the glioma responds to the treatment being recommended by the doctor. We are investigating whether one or both of these types of PET scans can help us to better understand gliomas and their response to treatment.
We expect these pictures will give us information the your tumor and may help us to understand why the treatment that the patient is receiving is affecting the tumor the way that it is. We also hope to collect information about the amount of radioactivity exposure. We will measure radioactivity exposure to the tumor, brain and other organs.
Eligibility Criteria
Inclusion Criteria
- Registered patient at MSKCC.
- Child-bearing age females must be non-pregnant, (documented by a negative pregnancy test within the last 2 weeks), non-lactating, and must be using adequate contraception or be surgically sterile.
- Patients with gliomas
- Patients planning to start anti-AKT and/or anti-VEGF directed therapies .
- Patients with measurable disease on MRI or CT neuroimaging.
Exclusion Criteria
- Patient is incontinent of urine or stool (which would make them unable to tolerate lying still for 60 minutes).
- Patient cannot tolerate lying still for a 60 minute session in the PET tomograph.
Data sourced from ClinicalTrials.gov (NCT00832598). 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.