Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Male or female, age 18 and older, of any ethnic group - Spanish-speaking patients will be eligible - Histological diagnosis of glioma or - Brain MR imaging suggestive of a glioma or 2HG > 2mM by MR spectroscopy in patients who have not had a surgical procedure to establish the diagnosis.
Exclusion Criteria:- Patient or legal parent/guardian unable to provide informed consent - Psychiatric or addictive disorders that preclude obtaining informed consent - Karnofsky Performance status < 70% - NYHA class III and IV congestive heart failure - Unstable angina - Pregnant or lactating women - Women of childbearing potential who refuse a pregnancy test
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Texas Southwestern Medical Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
1. [11C]Acetate Administration [11C]Acetate will be administered in the Clinical PET Facility located on the 2nd floor of the Clements Imaging Building at UT Southwestern. Upon arrival, the patient will have an opportunity to have questions answered regarding the procedure. 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. All adverse events occurring post [11C]Acetate infusion will be recorded within a 24-hour period. The adverse events to be specifically monitored during the infusion include localized discomfort at the IV injection site, pain, respiratory difficulties, flushing, dizziness, pruritus/rash, and any other symptoms that could be secondary to an anaphylactic reaction. The subject will be instructed to report any subjective symptoms or sensory changes noted. 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 as described in Section VI.F.3.b. A dynamic PET image will be acquired in 3D list mode for a total of 30 minutes. From the list mode data a flow image series will be constructed as follows:
- - 12 frames x 10 seconds each (out to 2 minutes post-injection) - then 6 frames x 30 seconds each - then 1 frame x 60 seconds each A second series will be -reconstructed to demonstrate dynamic brain regional metabolism as follows: - 12 frames x 10 seconds each (out to 2 minutes post-injection) - then 8 frames x 30 seconds each (from 2 to 6 minutes) - then 4 frames x 60 seconds each (from 6 to 10 minutes) - then 2 frames of 300 seconds each (from 10 to 20 minutes) - then 1 frame of 600 seconds (from 20 to 30 minutes) Reconstructions will be performed with a 128 x 128 image matrix using 3D OSEM (4 iterations, 21 subsets) and a 3 mm Gaussian filter.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.