Fusion Targeted Biopsy of the Prostate

NCT ID: NCT02013414

Last Updated: 2019-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2018-07-23

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

3D ultrasound-guided biopsy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Baowei Fei, PhD, EngD

Associate Professor and Georgia Cancer Coalition Dinstinguished Cancer Scholar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Baowei Fei, PhD, EngD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

R01CA156775

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21CA176684

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00045065

Identifier Type: -

Identifier Source: org_study_id