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

Recruiting

• Conditions: Cervical Cancer

• Registration Number: NCT05808933
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-06-20
• Status Verified: 2023-03
• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-29
• Last Update Submitted: 2023-03-29
• Study First Posted: 2023-04-12
• Last Update Posted: 2023-04-12
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Patients with biopsy-proven cervical cancer FIGO stage IA-IIA undergoing surgery;
• Women aged >18 years old;
• Signed Informed Consent.

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Exclusion Criteria

• Concurrent malignancies at other sites;
• Previous history of neoplasm;
• Refusal to sign written informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association between T1-, T2- and ADC-maps and LVSI status	3 months

Secondary Outcome Measures

Name	Time	Method
Correlation between T1-, T2- and ADC-maps and DFS and OS	3 years
Correlation between Radiomics-based analysis and LVSI status and DFS and OS	3 years

Trial Locations

Locations (1)

Fondazione Policlinico Universitaro "A. Gemelli" IRCCS; 🇮🇹 Roma, Italy