Clinical trial · Interventional
ARFI Imaging for Targeted Prostate Biopsy
Acoustic Radiation Force Impulse (ARFI) Imaging for Targeted Prostate Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Current sample size sufficiently powers the study to evaluate outcome measures
Summary
Brief summary (as posted)
The purpose of this study is to evaluate a new ultrasound technique. This technique may provide additional and improved information about the stiffness and sizes of the internal structures of your prostate in order to improve the guidance for a targeted biopsy. The investigational, custom-designed probe and needle guide will be used to produce images of your prostate and provide guidance for up to 4 additional biopsy samples (cores) prior to a standard magnetic resonance (MR) ultrasound fusion biopsy procedure. Above the time required for the MR ultrasound fusion biopsy, this study will take up to 30 additional minutes of time for collection of the investigational device guided collection of biopsy samples Risks of participation include increased time under anesthesia (to collect additional biopsies) and slight heating of tissue.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acoustic radiation force impulse (ARFI) | Device | — | UNRESOLVED |
| Ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Acoustic radiation force impulse (ARFI)
- description
- Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
- interventionNames
- Device: Acoustic radiation force impulse (ARFI)
- type
- ACTIVE_COMPARATOR
- label
- MR-ultrasound fusion
- description
- Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
- interventionNames
- Device: Ultrasound
Primary outcomes (13)
- measure
- Number of Participants in Whom the Biopsy Approach Detected the Presence of Prostate Cancer (PCa) of Any Grade
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men who are scheduled to undergo ultrasound fusion-MR prostate biopsy; * Men who are willing to participate in the study; * Subjects must freely sign informed consent to enroll in the study; * Assessing eligibility: eligibility for the study will be assessed, based upon the above criteria, by the participating urologist at the time of consultation. * 18 years or older Exclusion Criteria: * Men who have had previous treatment for PCa including radiation, cryoablation, chemotherapy, surgery, high intensity focused ultrasound (HIFU), laser therapy or hormone therapy; * Men who have had previous non-pharmacological invasive or minimally invasive treatment for benign prostatic hypertrophy (BPH) (i.e., TURP, TUMPT, WIT, TUNA, etc); * standard pharmacological treatment of BPH is allowable * Men who are mentally impaired and cannot give written consent; * Men with anomalies of the rectum.
References
Publications (3)
- RESULTChan DY. A 3-D Multiparametric Ultrasound Elasticity Imaging System for Targeted Prostate Biopsy Guidance [dissertation]. Durham (NC): Duke University; 2023.
- RESULTChan DY, Moavenzadeh SR, Wightman WE, Palmeri ML, Polascik TJ, Nightingale KR. Clinical Feasibility of 3-D Acoustic Radiation Force Impulse (ARFI) Imaging for Targeted Prostate Biopsy Guidance. Ultrason Imaging. 2025 Mar;47(2):79-92. doi: 10.1177/01617346241311901. Epub 2025 Jan 6. PMID 39760302
- RESULTMoavenzadeh SR, Chan DY, Adams ES, Deivasigamani S, Kotamarti S, Palmeri ML, Polascik TJ, Nightingale KR. Evaluation of 3D ARFI imaging of prostate cancer: diagnostic reliability and concordance with MpMRI. Cancer Imaging. 2025 Apr 23;25(1):55. doi: 10.1186/s40644-025-00874-0. PMID 40270056