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NCT05816005 Clinical Trial

Performance of Whole Body MRI in Extraplevic Disease Detection in Patients Undergoing Pelvic Exenteration for Gynecological Maligniancies

Gynecologic Cancer Clinical Trial

— WHOLE BODY  

Official title:
Performance of Whole Body MRI in Extraplevic Disease Detection in Patients Undergoing Pelvic Exenteration for Gynecological Maligniancies

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05816005
Other study ID # 3813
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date June 2024

Study information
Verified date March 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this prospective observational diagnostic study is to investigate the diagnostic accuracy od extrapelvic disease detection using Whole-body-MRI (WB-MRI) in patients with gynecologic cancer candidate to the pelvic exenteration.

Recruitment information / eligibility
Status Recruiting
Enrollment 71
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age > 18 years - Written Informed Consent - All patients with recurrent gynecological cancer that are planned to undergo pelvic exenteration or laterally extended pelvic resection, both with curative and palliative intent - Patients considered fit for srugery Exclusion Criteria: - Controindication to MRI (Claustrophobia, implanted ferromagnetic materials or foreign objects, Known intolerance or controindication to the MRI contrast agent, cardiac pacemaker) - Individuals who are not able or willing to tolerate the required prologed stationary supine position during examination (approximately 40-60 minutes) - Patient unable to give informed consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Fondazione Policlinico Universitaro "A. Gemelli" IRCCS Roma

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of diagnostic accuracy for extrapelvic disease detection using whole-body MRI Through study completion, an average of 2 yearS
Secondary Agreement between WB-MRI and PET-CT in detecting extrapelvic involvement Through study completion, an average of 2 yearS
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