Ex-vivo Investigation of Beta Probe for Prostate Cancer Resection
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/24/2017 |
| Start Date: | August 18, 2017 |
| End Date: | June 30, 2019 |
| Contact: | Courtney Dhondt |
| Email: | cgerler@iu.edu |
| Phone: | 317-274-1791 |
Pilot Ex-Vivo Investigation of an Experimental Beta Probe for Assessment and Guidance of Prostate Cancer Resection
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.
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.
Primary Objective To assess beta ray detection of prostate cancer ex-vivo using experimental
beta probe immediately after prostate cancer removal as determined by pathologist.
Secondary Objectives
- Compare preoperative standard of care staging via CT or MRI to 68Ga-PSMA-11 PET (CT or
MRI) findings.
- Compare preoperative 68Ga-PSMA-11 PET (CT or MRI) lesion measurements with postoperative
high-resolution PET of ex-vivo tissue.
- To compare the findings of each of the 68Ga-PSMA-11 detection methods to the surgical
observations and the clinical tissue histopathology findings.
Exploratory Objective Correlation of beta probe measurements with preoperative 68Ga-PSMA-11
PET (CT or MRI) lesion measurements, postoperative PET/CT ex-vivo images, surgical
observations, and pathology findings.
beta probe immediately after prostate cancer removal as determined by pathologist.
Secondary Objectives
- Compare preoperative standard of care staging via CT or MRI to 68Ga-PSMA-11 PET (CT or
MRI) findings.
- Compare preoperative 68Ga-PSMA-11 PET (CT or MRI) lesion measurements with postoperative
high-resolution PET of ex-vivo tissue.
- To compare the findings of each of the 68Ga-PSMA-11 detection methods to the surgical
observations and the clinical tissue histopathology findings.
Exploratory Objective Correlation of beta probe measurements with preoperative 68Ga-PSMA-11
PET (CT or MRI) lesion measurements, postoperative PET/CT ex-vivo images, surgical
observations, and pathology findings.
Inclusion Criteria
To be considered eligible to participate in this study, a patient must meet all the
inclusion criteria listed below:
1. ≥ 18 years of age
2. Must provide written informed consent
3. Presence of high grade prostate cancer (Gleason grade group 3-5) on prostate biopsy or
prostate cancer recurrence. Grade group scoring: 3 = Gleason 4+3, 4 = 4 + 4 or 4 + 5
or 5 + 4, 5 = 5+5.
4. Scheduled for prostate cancer removal
5. 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
1. Participation in another investigational trial involving research exposure to ionizing
radiation concurrently or within 30 days.
2. 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.
We found this trial at
2
sites
Indianapolis, Indiana 46202
Principal Investigator: Clinton D. Bahler, MD, MS
Phone: 317-274-1791
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535 Barnhill Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(888) 600-4822
Principal Investigator: Clinton D. Bahler, MD, MS
Phone: 317-274-1791
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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