Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma (FACBC)
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|ClinicalTrials.gov Identifier: NCT04114370|
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Glioma||Drug: 18F-fluciclovine||Early Phase 1|
In this pilot study the investigators propose to image 10 participants who have been previously diagnosed by resection or biopsy with grade 3 or 4 glioma.
All glioma cases undergoing resection at UPMC are evaluated by immunohistochemistry for mutations in p53, nuclear localization of ATRX, and the presence of IDH1R132H mutation as part of standard neuropathologic integrated diagnosis using the WHO 2016 diagnostic criteria. All glioma cases resected at UPMC undergo genetic profiling using next generation sequencing.
MRI imaging will be obtained as part of standard clinical care. The MRI sequences include T1 pre and post contrast, T2 FLAIR, DWI, ADC and perfusion sequences using the imaging algorithm for evaluating treatment response in glioma treatment trials. Radiogenomic analysis will be performed using the MRI imaging sequences obtained as standard clinical care.
|Study Type :||Interventional|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma|
|Actual Study Start Date :||October 22, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||September 30, 2021|
Experimental: Participants with Glioma
[F18]fluciclovine will be utilized to assess tumor viability compared with F-18 FDG PET or diagnostic MRI.
Prior to beginning PET imaging, 18F-fluciclovine will be administered as an intravenous bolus injection followed by a 10mL saline flush. 18F-fluciclovine will be injected through a cannula (or indwelling catheter) in an antecubital vein or another vein that will provide access. The administration site will be evaluated pre- and post-administration for any reaction. Documentation of administration to a participant will be recorded or as part of the scan upload, including date, prescription number, dose activity (as measured at time of administration), total volume, and start/stop time of administration.
- To assess the ability of [F-18]fluciclovine to differentiate radionecrosis (pseudoprogression) from tumor recurrence (progression) in patients after therapy, at imaging time points within the 12 week interval post chemoradiation. [ Time Frame: 90 minutes ]To assess the ability of [F-18]fluciclovine to differentiate pseudoprogression from progression as compared to F-18 FDG, regions of interest will be drawn around MRI anatomically defined enhancing tumor regions and translated to both the F-18 FDG and F-18 fluciclovine PET scans to obtain SUV for each tracer. The SUV values will be correlated with the diagnosis of pseudoprogression versus tumor progression as determined by the regression of lesion enhancement on subsequent standard clinical follow up MRI imaging, as described in the protocol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114370
|Contact: James Mountz, MD, PhDemail@example.com|
|Contact: Frank Lieberman, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||James M Mountz, MD||University of Pittsburgh|