Fusion Targeted Biopsy of the Prostate

August 23, 2019 updated by: Baowei Fei, PhD, EngD, Emory University

Molecular Image-directed, 3D Ultrasound-guided Biopsy of the Prostate

The objective of the proposed study is to evaluate a new, molecular image directed, three-dimensional (3D) ultrasound guided biopsy system in human patients. The current biopsy uses ultrasound imaging as guidance. However, the procedure uses two-dimensional (2D) ultrasound images and has sampling errors thus some cancers can be missed from the standard 2D image-guided biopsy. In this study, an FDA-approved ultrasound device will be used to obtain three-dimensional (3D) images of the prostate from a commercially available ultrasound scanner. The clinician can use the 3D images to guide biopsy, record the core location of the biopsy sites, and perform re-biopsy to the same sites in a patient follow-up examination. This system can also use images from magnetic resonance imaging (MRI) or positron emission tomography (PET) and then fuse PET or MR images with 3D ultrasound images to guide the needle to a suspicious tumor target as seen on MRI or PET. We think that this fusion targeted biopsy technology will help to improve the accuracy of the current systematic biopsy approach for prostate cancer detection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients must be 18 years or older
  • Abnormal uptake in prostate necessitating a biopsy
  • Able to provide informed consent

Exclusion Criteria:

  • Age less than 18
  • Cannot provide informed consent
  • Less than 2 months since any prior prostate biopsy (to decrease false positive uptake from inflammation)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D ultrasound-guided biopsy
Participants will have a 3D ultrasound-guided biopsy of the prostate rather than the standard of care 2D ultrasound-guided biopsy.
Device: 3D ultrasound-guided biopsy
Patients will have a PET/CT prior to the biopsy. The CT images will be combined with the PET images for improved localization of suspicious tumors. During the biopsy, the 3-D ultrasound images will be acquired immediately before the biopsy while the patient is on the table. The ultrasound images together with the PET images will be used to guide the targeted biopsy of the prostate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer Detection by Targeted and Standard Biopsy Approaches
Time Frame: Up to 2 years
The feasibility of detecting cancer detection with the targeted prostate biopsy was assessed. This study sought only to determine if the targeted biopsy approach was able to detect recurrent prostate cancer and values for the number of samples testing positive for cancer per each biopsy approach are not available. This feasibility study preceded a clinical trial (NCT02744534) assessing the accuracy of prostate cancer detection with targeted biopsies compared to the standard biopsy.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Baowei Fei, PhD, EngD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

July 23, 2018

Study Completion (Actual)

July 23, 2018

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

August 23, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00045065
  • R21CA176684 (U.S. NIH Grant/Contract)
  • R01CA156775 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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