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Trial Title:
Performance of Whole Body MRI in Extraplevic Disease Detection in Patients Undergoing Pelvic Exenteration for Gynecological Maligniancies
NCT ID:
NCT05816005
Condition:
Gynecologic Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Female
Gender based:
Yes
Gender description:
Only women can be included
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Universitaro "A. Gemelli" IRCCS
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giacomo G Avesani, MD
Phone:
0630156054
Phone ext:
+39
Email:
giacomo.avesani@policlinicogemelli.it
Start date:
July 1, 2021
Completion date:
June 2024
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05816005
