Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03990285 |
Other study ID # |
UPCC 08319/ IRB# 832812 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 1
|
First received |
|
Last updated |
|
Start date |
June 12, 2019 |
Est. completion date |
November 18, 2021 |
Study information
Verified date |
December 2021 |
Source |
Abramson Cancer Center of the University of Pennsylvania |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Subjects with histologically proven glioblastoma (GBM) who are suspected to have progression
and are candidates for a surgical resection according to standard of care may be eligible for
this study. Subjects may participate in this study if they are at least 18 years of age.
Positron emission tomography (PET/CT) imaging will be used to evaluate fluciclovine uptake at
sites of suspected progression before planned surgery. In addition, clinical brain MRI with
and without contrast will be used to evaluate the tumor pre-operatively. This is a
non-therapeutic trial in that imaging will not be used to direct treatment decisions.
Investigators anticipate enrolling up to 30 subjects who will undergo a clinical brain MRI
examination with and without contrast and a research 18F-Fluciclovine PET/CT scan of the
brain prior to surgery. They will also have a blood draw preoperatively to collect samples
for cfDNA analysis. PET/CT imaging sessions will include an injection of approximately 5 mCi
(range for most studies is anticipated to be 5 mCi +/- 20%) of 18F-Fluciclovine.
Description:
This is a pilot study in subjects with a histologically proven diagnosis of glioblastoma (GB)
who have completed chemoradiation and now have new contrast enhancing lesions or lesions
showing increased enhancement ( 25% increase) who are recommended for a clinical surgical
resection. Subjects may participate in this study if they are at least 18 years of age, most
participants will be receiving care at the clinical practices of the University of
Pennsylvania. Subjects who come to the University of Pennsylvania for diagnosis and/or
treatment of GB and who meet the study inclusion criteria may be approached by study
personnel for recruitment into this study. Subjects will be approached about study
participation regardless of race or ethnic background. Investigators anticipate enrolling up
to 30 participants. Subjects who consent but do not complete the study imaging will be
considered not evaluable and will be replaced. Accrual will likely occur over approximately
1-2 years. After undergoing screening assessments and verifying eligibility for study
participation subjects will undergo a research 18FFluciclovine PET/CT scan of the brain and a
clinical brain MRI with and without gadolinium contrast, all baseline imaging will be done
prior to (within 1 week) of the surgical procedure. The PET-CT and MRI can be performed in
any order.