F18 Fluciclovine PET/CT in Assessing Tumor Volume and Radiation Therapy Response in Patients With Glioblastoma Undergoing Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03926507|
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : May 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Procedure: Computed Tomography Other: Fluciclovine F18 Procedure: Positron Emission Tomography||Early Phase 1|
I. To compare fluciclovine F18 (F18 fluciclovine) PET CT for tumor volume assessment compared to T2 fluid attenuated inversion recovery (FLAIR) and T1 post contrast magnetic resonance (MR) brain imaging.
I. To assess changes in F18 fluciclovine defined disease with surgery and radiation.
II. To assess the relationship between post-radiation enhancing brain tissue and F18 fluciclovine activity.
I. To assess the association between results from pathology and F18 fluciclovine, T2 FLAIR, and T1 post-contrast MR brain imaging.
Patients receive fluciclovine F18 intravenously (IV) and undergo 4 PET/CT scans over 10 minutes paired with standard of care MRI within 14 days prior to initial maximal tumor resection, within 7 days prior to initiation of radiation therapy, 28 days after the completion of radiation therapy, and 6 months after the completion of radiation therapy.
After completion of study, patients will be followed up at 3 and 6 months.
|Study Type :||Interventional|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of F18 Fluciclovine PET CT for Assessment of Glioblastoma Tumor Volume and Radiation Response|
|Actual Study Start Date :||April 30, 2019|
|Estimated Primary Completion Date :||February 15, 2020|
|Estimated Study Completion Date :||February 15, 2020|
Experimental: Diagnostic (fluciclovine F18 PET/CT)
Patients receive fluciclovine F18 IV and undergo 4 PET/CT scans over 10 minutes paired with standard of care MRI within 14 days prior to initial maximal tumor resection, within 7 days prior to initiation of radiation therapy, 28 days after the completion of radiation therapy, and 6 months after the completion of radiation therapy.
Procedure: Computed Tomography
Undergo PET/CT scan
Other: Fluciclovine F18
Procedure: Positron Emission Tomography
Undergo PET/CT scan
- Tumor volume [ Time Frame: Up to 6 months ]Will be assessed with fluciclovine F18 (F18 fluciclovine) positron emission tomography (PET) computed tomography (CT). The three volumes measured (amino acid hypermetabolic volume [AHV], T2 fluid attenuated inversion recovery [FLAIR] and T1 contrast [T1C]) will be compared to each other for each patient, and plotted as boxplots, both raw (as mL) and as normalized values (to the T1C volume) to facilitate comparisons between patients.
- Changes in F18 fluciclovine defined disease with surgery and radiation [ Time Frame: Baseline up to 6 months ]Will compare tumor volumes measured by this method between the initial time point and the three follow-up time points within patients using Wilcoxon rank-sum tests.
- Post-radiation enhancing brain tissue [ Time Frame: Up to 6 months ]To assess the relationship between post-radiation enhancing brain tissue and F18 fluciclovine activity, will use rank correlation analysis.
- Results from pathology [ Time Frame: Up to 6 months ]Will use rank correlation analysis to assess the association between results from pathology and F18 fluciclovine, T2 FLAIR, and T1 post-contrast MR brain imaging. The association between tumor histology (glioma/non-glioma) and grade and tumor volumes from imaging results will be assessed using Wilcoxon rank-sum tests and rank correlation.
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): NCT03926507
|Contact: Jason M Johnsonemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jason M. Johnson 713-792-8443|
|Principal Investigator: Jason M. Johnson|
|Principal Investigator:||Jason M Johnson||M.D. Anderson Cancer Center|