[11C]Acetate PET in Patients With Glioma
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|ClinicalTrials.gov Identifier: NCT02986815|
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : September 9, 2019
At each point that the patient will have [11C]-Acetate PET study, this will be compared with standard clinical MR imaging. Abbreviations: XRT - radiation therapy; TMZ - temozolomide (chemotherapy)
Quantitative Image Data Analysis: The [11C]-Acetate uptake in tumor sites from images will be analyzed qualitatively by visual assessment, quantitatively using a standard uptake value (SUV) in the tumor relative to the contralateral normal brain, and the parameters obtained by compartmental modeling of dynamic data.
|Condition or disease||Intervention/treatment||Phase|
|Glioma||Other: [11C]Acetate Brain Imaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||[11C]Acetate PET in Patients With Glioma|
|Actual Study Start Date :||January 24, 2017|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: [11C]Acetate Brain Imaging
[11C]Acetate will be administered The patient will have one intravenous line placed prior to [11C]Acetate administration. The patient will receive the low-dose CT portion of a PET/CT scan, after which [11C]Acetate will be administered intravenously over approximately 1 min at a dose of 0.3 mCi/kg (maximum 30 mCi) and followed by a saline flush. The injection and imaging procedure will be terminated in any patient who exhibits anaphylaxis, significant dyspnea or chest pain. The administering physician will stay with the patient for at least 15 min after injection and will remain in the Clinical PET Facility through the duration of the imaging procedure.
Other: [11C]Acetate Brain Imaging
Patients will be imaged on a Siemens Biograph 64 slice PET CT scanner. After placing the patient on the scanner and securing the head in a head restraint, a low dose CT of the brain will be acquired. Images with 3 mm slice thickness and spaced at 1.5 mm intervals will be reconstructed in a 300 mm field of view. The purpose of the CT is for image localization and attenuation correction and it is not considered to be a diagnostic quality CT. Following the completion of the CT, the [11C]Acetate will be administered. A dynamic PET image will be acquired in 3D list mode for a total of 30 minutes.
- Visual differences from normal brain in patients with grades 2, 3 or 4 gliomas [ Time Frame: Every 3 months for 24 months ]Visual assessment and SUV with standard clinical MR imaging assessment.using T2/FLAIR and gadolinium enhancement.
- Decrease in [11C]Acetate uptake following treatment of grade 2 glioma [ Time Frame: Every 3 months for 24 months ]Change from baseline in single imaging field over the brain, imaged dynamically for 30 minutes following the start of a 1-min intravenous infusion of [11C]Acetate
- Decrease in [11C]-acetate uptake following treatment of grade 3 and 4 glioma [ Time Frame: Every 3 months for 24 months ]Change from baseline in single imaging field over the brain, imaged dynamically for 30 minutes following the start of a 1-min intravenous infusion of [11C]Acetate.
- Change in [11C]-acetate uptake following treatment at time of progression in grade 3 and 4 gliomas [ Time Frame: Every 3 months for 24 months ]Change from baseline in single imaging field over the brain, imaged dynamically for 30 minutes following the start of a 1-min intravenous infusion of [11C]Acetate
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): NCT02986815
|Contact: Sarah S McNeil, RNfirstname.lastname@example.org|
|Contact: Robert Bachoo, MD, PhDemail@example.com|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75063|
|Contact: Sarh McNeil, RN 214-645-8166 firstname.lastname@example.org|
|Principal Investigator: Robert Bachoo, MD|