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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01639859
Other study ID # 2011.658
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2011
Est. completion date August 2013

Study information

Verified date September 2011
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary aim of the study is to assess the elasticity (Young's modulus) of cancerous tumor foci, of normal peripheral zone, and of normal transition zone in the prostate. Images obtained with the Supersonic Imagine Aixplorer scanner prior to radical prostatectomy are compared to whole-mount histology.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 2013
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient over 18 years old, with prostate cancer and scheduled for radical prostatectomy

Exclusion Criteria:

- Medical history of prostate surgery or radiotherapy of prostate

- Medical history of abdominal perinéanal amputation or whole of state which prevent to use endorectal probe

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Elastography
The elastography in vivo will be performed before the prostatectomy. The elastography ex vivo will be performed after radical prostatectomy.

Locations

Country Name City State
France Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

Rouvière O, Melodelima C, Hoang Dinh A, Bratan F, Pagnoux G, Sanzalone T, Crouzet S, Colombel M, Mège-Lechevallier F, Souchon R. Stiffness of benign and malignant prostate tissue measured by shear-wave elastography: a preliminary study. Eur Radiol. 2017 M — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Young's modulus(kPa) of cancerous tumor foci 2 years
Primary Young's modulus(kPa) of normal peripheral zone 2 years
Primary Young's modulus(kPa) of normal transition zone 2 years
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