Magnetic Resonance Fingerprinting in the Imaging of Endometrial Cancer

Endometrial Cancer Clinical Trial

— MARF-E  

Official title:

MARF-E- Magnetic Resonance Fingerprinting in the Imaging of Endometrial Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05807672
• Other study ID #: 4690
• Status: Recruiting
• Start date: April 23, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Benedetta B Gui, MD
• Phone: +39 0630156054
• Email: benedetta.gui[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this context, the aim of this study is to investigate the role of MRF in endometrial cancer. Several applications are possible. Firstly, T1-, T2- and DWI-mappings can be associated to molecular risk group classification, in order to stratify patients' risk without recurring to surgery. MRF parameters can be also correlated to prognosis, both in terms of disease-free survival (DFS) and overall survival (OS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with biopsy-proven endometrial cancer;

• Women aged > 18 years old;

• Signed Informed consent.

Exclusion Criteria:

• Previous history of neoplasm;

• Concurrent malignancies at other sites.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

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	Association between T1-, T2- and diffusion-mappings and risk group classification		3 months
Secondary	Diagnostic accuracy of T1-,T2- and diffusion-mappings deriving from MRF in myometrial invasion detection		3 months
Secondary	Correlation between T1-, T2- and diffusion mappings and DFS and OS		3 years
Secondary	Diagnostic accuracy of T1-,T2- and diffusion-mappings and pathological nodal involvement		3 months
Secondary	Evaluation of Radiomic and Radiogenomic models to predict recurrence in early stage EC and to predict DFS and OS		3 years