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NCT05808933 Clinical Trial

Magnetic Resonance Fingerprinting for Preoperative Evaluation of Lymphovascular Space Invasion in Early Stage Cervical Cancer

Cervical Cancer Clinical Trial

— MARF-ESC  

Official title:
Magnetic Resonance Fingerprinting for Preoperative Evaluation of Lymphovascular Space Invasion in Early Stage Cervical Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05808933
Other study ID # 4988
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 20, 2022
Est. completion date December 2027

Study information
Verified date March 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Benedetta B Gui, MD
Phone 0630155464
Email benedetta.gui@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this observational prospective study is to investigate the role of Magnetic Resonance Fingerprinting in preoperative assessment of early cervical cancer

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date December 2027
Est. primary completion date December 2027
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with biopsy-proven cervical cancer FIGO stage IA-IIA undergoing surgery; - Women aged >18 years old; - Signed Informed Consent. Exclusion Criteria: - Concurrent malignancies at other sites; - Previous history of neoplasm; - Refusal to sign written informed consent

Study Design

Related Conditions & MeSH terms

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 ADC-maps and LVSI status 3 months
Secondary Correlation between T1-, T2- and ADC-maps and DFS and OS 3 years
Secondary Correlation between Radiomics-based analysis and LVSI status and DFS and OS 3 years
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