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

April 14, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of diagnostic accuracy for extrapelvic disease detection using whole-body MRI
Time Frame: Through study completion, an average of 2 yearS
Through study completion, an average of 2 yearS

Secondary Outcome Measures

Outcome Measure
Time Frame
Agreement between WB-MRI and PET-CT in detecting extrapelvic involvement
Time Frame: Through study completion, an average of 2 yearS
Through study completion, an average of 2 yearS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 3813

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gynecologic Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe