[18F]Fluciclovine in Post-treatment Glioblastoma ( Axumin ) (Axumin)
|ClinicalTrials.gov Identifier: NCT03990285|
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : July 23, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Glioma Glioblastoma Multiforme||Drug: Axumin, Intravenous Solution||Phase 1|
|Study Type :||Interventional|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||To compare 18F-fluciclovine PET uptake measures in glioblastoma patients with tumor progression vs pseudoprogression. To determine a multidimensional signature using 18F-fluciclovine PET, MRI, and plasma cfDNA that accurately differentiates tumor progression from pseudoprogression in post-chemoradiation GBM.|
|Masking:||None (Open Label)|
|Official Title:||Multimodality 18F-Fluciclovine PET, MRI and Cell Free Circulating DNA to Differentiate Tumor Progression From Pseudoprogression in Patients With Glioblastoma|
|Actual Study Start Date :||June 12, 2019|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||January 2022|
[18F]Fluciclovine in glioblastoma
Axumin is a positron emitting radiopharmaceutical that has been studied in vivo in humans in a number of tumor types with positron emission tomography (PET/CT). 18F-Fluciclovine is a fluorine-18 labeled synthetic amino acid analog that is FDA approved as a PET imaging agent for prostate cancer recurrence, however, it has also been tested in other tumors. Investigators will use a typical dose of 18F-fluciclovine that is used for clinical studies in glioblastoma. This will be 5 mCi (approximate range for most studies is anticipated to be 5 mCi +/- 20%), but a lesser dose may be injected if, in the opinion of a Nuclear Medicine Authorized User, complete imaging data could be generated.
Drug: Axumin, Intravenous Solution
To compare 18F-fluciclovine PET uptake measures in glioblastoma patients with tumor progression versus pseudoprogression
- Pseudoprogression or tumor progression by histopathology [ Time Frame: 2Years ]
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): NCT03990285
|Contact: Leeanne Lezottefirstname.lastname@example.org|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Leeanne Lezotte 215-615-5462|
|Contact: Lisa Desiderio 215-746-7632|
|Principal Investigator: Seyed Ali Nabavizadeh, MD|