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Ex-vivo Investigation of Beta Probe for Prostate Cancer Resection and Evaluation of PSMA-PET for Diagnosis of Intraprostatic Lesions

NCT03213951 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2023-03-28

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Experimental beta probe

3mCi (or similar) dose of 68Ga-PSMA-11 will be given prior to resection of cancer. Experimental beta probe designed to detect 68Ga-PSMA-11 will be used on prostate tissue after it has been surgically removed.

DIAGNOSTIC_TEST

PSMA-PET

PSMA-PET imaging done prior to surgery and compared to whole mount imaging.

Sponsors & Collaborators

  • IntraMedical Imaging, LLC

    collaborator UNKNOWN

  • Indiana University

    lead OTHER

Principal Investigators

  • Clinton D. Bahler, MD, MS · Indiana Unversity

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-18
Primary Completion
2019-11-13
Completion
2019-11-13

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03213951 on ClinicalTrials.gov