Magnetic Resonance Fingerprinting in the Imaging of Endometrial Cancer

NCT05807672 | Unknown

• 1 other identifier: 4690
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• Association between T1-, T2- and diffusion-mappings and risk group classification

  3 months

Secondary Outcomes (4)

• Diagnostic accuracy of T1-,T2- and diffusion-mappings deriving from MRF in myometrial invasion detection

  3 months

• Correlation between T1-, T2- and diffusion mappings and DFS and OS

  3 years

• Diagnostic accuracy of T1-,T2- and diffusion-mappings and pathological nodal involvement

  3 months

• Evaluation of Radiomic and Radiogenomic models to predict recurrence in early stage EC and to predict DFS and OS

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that undergo to clinics/hospitalization examination at Fondazione Policlinico Universitario "A. Gemelli" IRCCS for endometrial cancers will be candidate to partecipate to this study, according to exclusion and inclusion criteria.

You may qualify if:

• Patients with biopsy-proven endometrial cancer;
• Women aged \> 18 years old;
• Signed Informed consent.

You may not qualify if:

• Previous history of neoplasm;
• Concurrent malignancies at other sites.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitaro "A. Gemelli" IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Benedetta B Gui, MD

CONTACT

+39 0630156054; benedetta.gui@policlinicogemelli.it

Benedetta B Gui, MD

CONTACT

0630156054; benedetta.gui@policlinicogemelli.it

Study Design

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

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 11, 2023
• Study Start: April 23, 2022
• Primary Completion: April 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 11, 2023

Record last verified: 2023-03

Locations

IT (1)