Mesenteric Infiltration in Ovarian Cancer

Recruiting

• Conditions: Ovary Cancer
• Interventions: Diagnostic Test: Computed Tomography

• Registration Number: NCT06331130
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

To evaluate if CT features at diagnosis in patients with HGSOC can be used to build an Artificial Intelligence model capable of discerning the pathological involvement of the mesentery, assessing the potential impediments for an optimal debulking surgery and predicting the development of resistance to platinum based chemotherapeutic agents.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-19
• Study First Posted: 2024-03-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 510

Inclusion Criteria

1. Women with confirmed HGSOC wiht mesenteric involvment
2. Age > 18 years
3. FIGO STAGE IIIB-IV
4. Primary diagnosis
5. Signed informed consent

Exclusion Criteria

1. Non-serous high grade epithelial ovarian cancer (serous low grade, mucinous, clear cell carcinoma, endometrioid or non-epithelial ovarian cancer)
2. Early stage disease (I and II stage)
3. CT scan not available
4. Non-primary diagnosis or patient subjected to neoadjuvant chemotherapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective cohort	Computed Tomography	Patients affected by High Grade Seruous Ovarian Cancer with mesenteric infiltration confirmed by diagnostic laparoscopy
Retrospective cohort	Computed Tomography	Patients affected by High Grade Seruous Ovarian Cancer with mesenteric infiltration confirmed by diagnostic laparoscopy, from January 2021 to December 2023

Primary Outcome Measures

Name	Time	Method
Preoperative Artificial Intelligence assisted CT-based evaluation	1 year	Preoperative Artificial Intelligence assisted CT-based prediction of patients with suboptimal debulking at surgery due to diffuse mesenteric disease or mesenteric retraction.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the Radiologist Assessment of the CT	1 year	Identification of mesenteric infiltration from CT images using Artificial Intelligence at a comparable performance with human/radiologist assessment.
Prediction of Platinum Resistance	1 year	AI-assisted CT-based prediction of patients who will develop platinum resistance
Prediction of Progression Free Survival (PFS) and Overall Survival (OS)	2 years	Prediction of Progression Free Survival (PFS) and Overall Survival (OS) with Artificial Intelligence

Trial Locations

Locations (1)

Advanced Radiology Center; 🇮🇹 Roma, Italy