Trial Outcomes & Findings for A Pilot Trial of Sonoelastography for Planning Tumor-targeted Prostate Biopsy (NCT NCT01748890)

NCT ID: NCT01748890

Last Updated: 2017-10-20

Results Overview

From elastography-prostatectomy pathology correlation, the following data will be obtained, 1) The number of planned core biopsies that would intersect foci of prostate carcinoma, 2) The Gleason Score that would be obtained, assuming that elastographically targeted biopsies sample the targeted region.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Participants will be followed until prostatectomy pathology is available (average 1 week)

Results posted on

2017-10-20

Participant Flow

Participant milestones

Participant milestones
Measure
Sonoelastography
Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness. Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.
Overall Study
STARTED
4
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
4

Reasons for withdrawal

Reasons for withdrawal
Measure
Sonoelastography
Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness. Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.
Overall Study
Insufficient recruitment for analysis
4

Baseline Characteristics

A Pilot Trial of Sonoelastography for Planning Tumor-targeted Prostate Biopsy

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Participants will be followed until prostatectomy pathology is available (average 1 week)

Population: insufficient recruitment for analysis

From elastography-prostatectomy pathology correlation, the following data will be obtained, 1) The number of planned core biopsies that would intersect foci of prostate carcinoma, 2) The Gleason Score that would be obtained, assuming that elastographically targeted biopsies sample the targeted region.

Outcome measures

Outcome data not reported

Adverse Events

Sonoelastography

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anthony E. Samir

Massachusetts General Hospital

Phone: 6178523241

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place