An observational study in Prostate Cancer, sponsored by University of Michigan. Completed at 1 site in United States. Open to male participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-09.
Sponsored by University of Michigan · Observational
Men with and without prostate cancer will have a PET/CT scan that measures the level of the amino acid sarcosine. PET is a scanning method that uses short lived radioactivity.
Tissue levels of the amino acid sarcosine are elevated in prostate cancer compared to normal prostate tissues and further increased in metastases from prostate cancer. This research project is designed to test whether 11C-sarcosine (a chemical that is linked to short lived radioactivity) would be useful to detect prostate cancer in men using PET/CT imaging. The uptake and distribution of 11C-sarcosine in men with known or suspected prostate cancer will be determined and compared with results from 11C-choline PET/CT.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 20 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
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Group 1: Subjects with confirmed or suspected prostate cancer who will undergo a planned tissue biopsy of the known or suspected tumor
Group 2: Healthy volunteers.
Exclusion Criteria:
Subjects will receive two PET/CT examinations, one with 11C-sarcosine and one with 11C-choline. These scans will take 30-45 minutes each.
Drug: 11C-sarcosine · Drug: 11C-choline
Subjects will receive one PET/CT examination, with 11C-sarcosine. This scan will take approximately 90 minutes.
Drug: 11C-sarcosine
Radiotracer injection for PET/CT scan
Radiotracer injection for PET/CT scan
Evaluation of biodistribution of 11C-sarcosine in prostate cancer patients
Time frame: One Month
Evaluation of radiation dosimetry of 11C-sarcosine in healthy volunteers
Time frame: One Month
Comparison of the uptake measures of 11C-sarcosine with those from 11C-choline
Standardized uptake (SUV) values from tumor tissues relative to background, also called tumor-to-background ratios (TBR), will be determined from both, 11C-sarcosine and 11C-choline. Then TBR measurements from 11C-choline and 11C-sarcosine will be compared to identify whether 11C-sarcosine improves tumor to background image contrast relative to 11C-choline in prostate cancer.
Time frame: One Month
Evaluation of underlying metabolic pathways of sarcosine in prostate cancer tissues obtained from tissue materials
Time frame: One Month
Evaluation of the relationship between sarcosine (and metabolite) tissue concentrations and 11C-sarcosine/11C-choline plasma and tissue uptake measures
Time frame: One Month
Plan to share: No
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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University of Michigan