Fusion Targeted Biopsy of the Prostate
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3D ultrasound-guided biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
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)
Sites / Locations
- Emory University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3D ultrasound-guided biopsy
Arm Description
Participants will have a 3D ultrasound-guided biopsy of the prostate rather than the standard of care 2D ultrasound-guided biopsy.
Outcomes
Primary Outcome Measures
Cancer Detection by Targeted and Standard Biopsy Approaches
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02013414
First Posted
November 19, 2013
Last Updated
August 23, 2019
Sponsor
Emory University
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02013414
Brief Title
Fusion Targeted Biopsy of the Prostate
Official Title
Molecular Image-directed, 3D Ultrasound-guided Biopsy of the Prostate
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
July 23, 2018 (Actual)
Study Completion Date
July 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3D ultrasound-guided biopsy
Arm Type
Experimental
Arm Description
Participants will have a 3D ultrasound-guided biopsy of the prostate rather than the standard of care 2D ultrasound-guided biopsy.
Intervention Type
Device
Intervention Name(s)
3D ultrasound-guided biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cancer Detection by Targeted and Standard Biopsy Approaches
Description
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.
Time Frame
Up to 2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baowei Fei, PhD, EngD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Fusion Targeted Biopsy of the Prostate
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