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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03213951
Recruitment Status : Active, not recruiting
First Posted : July 11, 2017
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
IntraMedical Imaging, LLC
Information provided by (Responsible Party):
Clinton Bahler, Indiana University

Brief 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.

Condition or disease Intervention/treatment
Prostate Cancer Other: Experimental beta probe Diagnostic Test: PSMA-PET

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Ex-Vivo Investigation of an Experimental Beta Probe for Assessment and Guidance of Prostate Cancer Resection
Actual Study Start Date : August 18, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Prostate cancer
Gleason grade group 1-5 on prostate biopsy or prostate cancer recurrence.
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.




Primary Outcome Measures :
  1. Proportion of patients where prostate cancer was detected using the beta probe on excised prostate tissue [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Proportion of patients who had cancer detected by both the standard of care imaging (CT or MRI) and the 68Ga-PSMA-11 PET (CT or MRI) imaging [ Time Frame: 1 day ]
  2. Proportion of patients who had cancer detected by the beta probe on excised prostate tissue compared with surgical observations [ Time Frame: 1 day ]
  3. Proportion of patients who had cancer detected by the beta probe on excised prostate tissue compared with clinical tissue histopathology observations [ Time Frame: 1 day ]
  4. Comparison of pre-operative 68Ga-PSMA-11 (CT or MRI) lesions measurements with post-operative ex-vivo PET of prostate tissue [ Time Frame: 1 day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This patient population will have Prostate cancer with planned surgical resection (GG2-5) of prostate cancer as part of routine clinical care or active surveillance/HIFU (GG1-3).
Criteria

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 1-5) on prostate biopsy or prostate cancer recurrence.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213951


Locations
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United States, Indiana
Indiana University Health Hospital
Indianapolis, Indiana, United States, 46202
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
IntraMedical Imaging, LLC
Investigators
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Principal Investigator: Clinton D. Bahler, MD, MS Indiana Unversity

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Responsible Party: Clinton Bahler, Assistant Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT03213951     History of Changes
Other Study ID Numbers: IUSCC-0615
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clinton Bahler, Indiana University:
Surgical resection
Margins of resection
Beta radiopharmaceutical
Beta probe device
Ex-vivo
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases