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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02618200
Other study ID # 69HCL15_0100
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2016
Est. completion date August 31, 2017

Study information

Verified date August 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prostate cancer is currently detected by ultrasound-guided biopsy. Computer-aided diagnostic (CAD) systems based on multiparametric MRI are now capable of detecting most aggressive cancer foci non-invasively, but additional progress is needed for the technique to be accepted in clinical practice. We hypothesize that combining MRI and ultrasound imaging can improve the detection of cancerous tumors. As a first step in this direction, we need to create a database with MR images, 3D ultrasound images, and corresponding histopathology results, in patients treated by radical prostatectomy for prostate cancer. This is the purpose of the present study.

In a later stage (outside the scope of this study), we will be learning how to combine these images to best recognize cancerous tumors, we will use that knowledge to develop a new CAD system, and we will assess the performance of the new CAD. We expect this future system to improve the detection of prostate cancer and to reduce the number of patients requiring biopsy.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date August 31, 2017
Est. primary completion date August 31, 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient referred for radical prostatectomy

- Patient with multiparametric prostate MRI (3T) performed in our institution (Edouard Herriot Hospital) in the year preceding the surgery

- Informed consent signed

- Patient affiliated to the French Health Insurance system

Exclusion Criteria:

- History of prostatic surgery or radiation therapy (prostatic or pelvic)

- History of hormone therapy for prostate cancer

- Previous surgery of the abdomino-perineal region, or other contraindication for transrectal ultrasound

- Patient on protection of the court, under supervision or under trusteeship

- Inability to express a consent

Study Design


Related Conditions & MeSH terms


Intervention

Device:
3D prostate ultrasound


Locations

Country Name City State
France Hôpital Edouard Herriot - Service Service de radiologie LYON cedex 03

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Obtention of 3D ultrasound images the day before radical prostatectomy
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