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

NCT05816005 | Unknown

• 1 other identifier: 3813
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of diagnostic accuracy for extrapelvic disease detection using whole-body MRI

  Through study completion, an average of 2 yearS

Secondary Outcomes (1)

• Agreement between WB-MRI and PET-CT in detecting extrapelvic involvement

  Through study completion, an average of 2 yearS

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women can be included
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pelvic maligniancies that will undergo to preoperative contrast enhanced MRI to precisely define the extent of local and/or distant disease before pelvic exenteration

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitaro "A. Gemelli" IRCCS

Roma, 00168, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 18, 2023
• Study Start: July 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-03

Locations

IT (1)