Assessment of Supersonic Imagine Aixplorer for the Detection and Localisation of Prostate Cancer Foci

Cancer of Prostate Clinical Trial

— PROSTATE SSI  

Official title:

Assessment of Supersonic Imagine Aixplorer for the Detection and Localisation of Prostate Cancer Foci

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639859
• Other study ID #: 2011.658
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cancer of Prostate
• Prostatic Neoplasms

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