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Clinical Trials/NCT02013414
NCT02013414
Completed
N/A

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

Emory University1 site in 1 country9 target enrollmentSeptember 2013
ConditionsProstate Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Emory University
Enrollment
9
Locations
1
Primary Endpoint
Cancer Detection by Targeted and Standard Biopsy Approaches
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
July 23, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Baowei Fei, PhD, EngD

Associate Professor and Georgia Cancer Coalition Dinstinguished Cancer Scholar

Emory University

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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.

Study Sites (1)

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