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OpenTrials
Completed

NCT Number: NCT02013414

Fusion Targeted Biopsy of the Prostate

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

3D ultrasound-guided biopsy

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 17, 2013
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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