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Fusion Targeted Biopsy of the Prostate

Emory University logo

Emory University

Status

Completed

Conditions

Prostate Cancer

Treatments

Device: 3D ultrasound-guided biopsy

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02013414
IRB00045065
R01CA156775 (U.S. NIH Grant/Contract)
R21CA176684 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

3D ultrasound-guided biopsy
Experimental group
Description:
Participants will have a 3D ultrasound-guided biopsy of the prostate rather than the standard of care 2D ultrasound-guided biopsy.
Treatment:
Device: 3D ultrasound-guided biopsy

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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