Mesenteric Infiltration in Ovarian Cancer

Ovary Cancer Clinical Trial

— MIO  

Official title:

CT Detected Tumour Infiltration Patterns of the Mesentery in High Grade Ovarian Carcinoma (HGSOC) Patients, Their Role in Treatment Planning and Outcome Prediction and How Machine Learning Can be Applied to Identify Them.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06331130
• Other study ID #: 6363
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 510
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Neoplasms
• Ovary Cancer

Intervention

Diagnostic Test:
• Computed Tomography
Computed Tomography done according to Clinical Practice to assess mesenteric involvment

Locations

Country	Name	City	State
Italy	Advanced Radiology Center	Roma

Sponsors (4)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Danube University Krems, Ente Ospedaliero Cantonale, Ticino, Switzerland, Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative Artificial Intelligence assisted CT-based evaluation	Preoperative Artificial Intelligence assisted CT-based prediction of patients with suboptimal debulking at surgery due to diffuse mesenteric disease or mesenteric retraction.	1 year
Secondary	Evaluation of the Radiologist Assessment of the CT	Identification of mesenteric infiltration from CT images using Artificial Intelligence at a comparable performance with human/radiologist assessment.	1 year
Secondary	Prediction of Platinum Resistance	AI-assisted CT-based prediction of patients who will develop platinum resistance	1 year
Secondary	Prediction of Progression Free Survival (PFS) and Overall Survival (OS)	Prediction of Progression Free Survival (PFS) and Overall Survival (OS) with Artificial Intelligence	2 years