Fusion Targeted Biopsy of the Prostate

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: 3D ultrasound-guided biopsy

• Registration Number: NCT02013414
• Lead Sponsor: Emory University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-17
• Primary Completion: 2018-07-23
• Study Completion: 2018-07-23
• Results First Submitted: 2019-07-22
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-23
• Last Update Submitted: 2019-08-23
• Results First Posted: 2019-09-17
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3D ultrasound-guided biopsy	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.

Primary Outcome Measures

Name	Time	Method
Cancer Detection by Targeted and Standard Biopsy Approaches	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.

Trial Locations

Locations (1)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States