Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-08563 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will investigate the use of Hydrogen 1 (1H) magnetic resonance spectroscopy (MRS) with deuterated glucose (2H-glucose) to detect dynamic glucose uptake in the brain.
PRIMARY OBJECTIVE:
OUTLINE:
Participants with and without glioma will be evaluated to develop a robust strategy for obtaining 2H-glucose metabolism in twenty healthy participants (cohort 1) and thirty participants with glioma (cohort 2), while the remaining thirty glioma participants will be studied at baseline and after completion of non-investigational therapy (cohort 3).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Healthy Controls | Twenty healthy controls for will have 2H-glucose metabolism in measured for development of robust strategy in optimizing acquisition parameters. |
| |
| Cohort 2: Glioma participants (Single Time point) | Thirty participants with glioma who may or may not have received prior treatment for testing the optimized imaging protocol developed in Cohort 1. |
| |
| Cohort 3: Glioma participants (Multiple Time points) | Thirty participants who will receive non-investigational treatment for glioma enrolled to test the evaluation for treatment induced metabolic changes at baseline and post- non-investigational treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deuterated Glucose | Drug | Given orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Signal-to-noise ratio (Cohort 1 & 2) | The signal-to-noise ratio (SNR) in metabolite concentrations will be calculated and compared on a voxel-by-voxel basis and via summary parameters (mean, median, and max) from the regions of interest (ROIs) of the anatomic and metabolic lesions on the imaging scan. Peaks with SNR > 5.0 are considered detectable | Day of imaging (1 day) |
| Mean difference in metabolite concentrations (Cohort 1 & 2) | Mean difference in metabolite concentrations of 2H labeling of these metabolites will be calculated and compared on a voxel-by-voxel basis and via summary parameters (mean, median, and max) from the ROIs of the anatomic and metabolic lesions. | Day of imaging (1 day) |
| Mean difference in fractional enrichment (Cohort 1 & 2) | Mean difference in fractional enrichment of 2H labeling of these metabolites will be calculated and compared on a voxel-by-voxel basis and via summary parameters (mean, median, and max) from the ROIs of the anatomic and metabolic lesions. | Day of imaging (1 day) |
| Mean metabolic turnover over time (Cohort 3) | Estimates of the extent of change over time following non-investigational treatment obtained at the baseline and one repeated after receiving treatment will be compared. | Up to 21 days after the completion of non-investigational treatment |
Not provided
Not provided
Inclusion Criteria:
Participants must be >= 18 years old
Participants must not have any significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the subject's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent.
Participants must not have a history of any other cancer unless they are in complete remission and have been off all therapy for that disease for a minimum of 3 years.
Participants must not be pregnant or breast-feeding. Persons of childbearing potential are required to obtain a negative serum or urine pregnancy test within 14 days of the scan. Effective contraception (men and women) must be used in subjects of childbearing potentials.
Participants must sign an informed consent indicating that they are aware of the investigational nature of the study
Exclusion Criteria:
Participants must be excluded from participating in this study if they are not able to comply with the study and/or follow-up procedures.
Not provided
Not provided
Not provided
Healthy adults and adult patient referrals from the UCSF Neuro-Oncology Service and Department of Neurological Surgery.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yan Li, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D005947 | Glucose |
| D009682 | Magnetic Resonance Spectroscopy |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D013057 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Magnetic Resonance Imaging (MRI) | Procedure | Imaging procedure performed at University of California, San Francisco |
|
|
| Blood Sample | Procedure | Capillary blood from the fingertip |
|
| MR spectroscopy (MRS) | Procedure | Imaging procedure performed at University of California, San Francisco |
|
|
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |