Pilot ex-vivo investigation of an experimental beta probe for assessment and guidance of prostate cancer resection
Clinton Bahler, MD
Primary Investigator
Brief description of study
68Ga-PSMA is a radiopharmaceutical used with PET imaging for the detection of prostate cancer under a compassionate IND in patients who have presented with biochemical failure. In this study, the use of 68Ga-PSMA-11 will be extended to newly diagnosed patients with high risk prostate cancer. Patients enrolled to this study will undergo a 68Ga-PSMA-11 PET/CT or PET/MRI scan for research purposes (in addition to the routine CT or MRI that is routinely done for staging), and a second 68Ga-PSMA-11 administration just prior to surgery for experimental ex-vivo beta probe testing of resected tissue. Immediately following resection of the prostate, the intact tissue will be scanned using a PET camera designed for animal research in order to record the 68Ga-PSMA-11 distribution in the isolated tissue at higher resolution than can be attained using whole-body PET imaging. The experimental beta probe will then be use to measure 68Ga-PSMA-11 counts of the resected tissue.
Detailed description of study
The purpose of this study is to assess beta ray detection of prostate cancer ex-vivo using an experimental beta probe immediately after prostate cancer removal.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: prostate cancer
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
Presence of high grade prostate cancer (Gleason grade group 3-5) on prostate biopsy or prostate cancer recurrence
Scheduled for prostate cancer removal
Willing and able to lie still for approximately 30 minutes in an enclosed space for the 68Ga-PSMA-11 PET CT or MRI
Exclusion Criteria
Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days
Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study
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