Satisfactory Debulking Prediction Model for Advanced Ovarian Cancer Based on PET-CT Image Data

Recruiting

• Conditions: Ovarian Cancer; Image; Predation
• Interventions: Diagnostic Test: Radio-score

• Registration Number: NCT06533709
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

This project intends to conduct a multicenter retrospective study to evaluate the satisfactory reduction of advanced ovarian cancer using PET-CT images, and explore the correlation between molecular biological characteristics and clinical characteristics of ovarian cancer through high-throughput sequencing genomics combined with radiomics.

Detailed Description

Ovarian cancer is the gynecological malignant tumor with the highest fatality rate. More than 70% of patients are diagnosed with advanced stage, often involving various organs of the pelvis and abdomen, which increases the difficulty of surgical resection, and the 5-year survival rate is only 30%. Surgical treatment is the cornerstone of the treatment of ovarian cancer, and whether it can achieve satisfactory tumor reduction is an important factor affecting the prognosis of ovarian cancer. At present, the methods used to evaluate whether satisfactory tumor reduction can be achieved include Suidan score based on CT image and Fagotti score based on laparoscopic exploration, but there are problems such as low sensitivity, poor specificity or strong subjectivity, and the efficiency of predicting satisfactory tumor reduction is only about 60%. In recent years, PET-CT has been widely used in tumor diagnosis. Pet-ct combined with PET metabolic imaging technology and traditional CT scanning can help to distinguish the nature of tumors, assess the systemic tumor load, define the scope of the lesion, and provide the metabolic status of various parts of the body. The application value of PET-CT related imaging features and metabolic information in ovarian cancer needs to be clarified. Our team's previous study found that PET-CT related images and metabolic information showed certain advantages in predicting satisfactory resection of ovarian cancer, and the AUC reached 0.85, which was better than the current CT image score and laparoscopic score. Therefore, this project intends to conduct a multicenter retrospective study to evaluate the satisfactory tumor reduction rate of advanced ovarian cancer using PET-CT images to guide clinical practice and predict the prognosis of patients. At the same time, we will explore the molecular biological characteristics and clinical relevance of ovarian cancer through the combination of high-throughput sequencing genomics and radiomics.

Study Timeline

• Study Start: 2024-06-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-07-30
• Last Update Submitted: 2024-07-30
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 146

Inclusion Criteria

• Pathological type is epithelial ovarian cancer.
• Underwent primary debulking surgery at our hospital.
• Postoperative pathological staging is FIGO stage IIB or above.
• Clinical, surgical, and pathological data of the patient are mostly complete.

Exclusion Criteria

• Pathological type is non-epithelial ovarian cancer.
• Underwent fertility-preserving surgery or palliative surgery.
• Presence of infection during PET/CT image acquisition.
• Concurrent other malignant tumors.
• Severe diseases of other major organs.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ZJCH cohort	Radio-score	Patients cohort from Zhejiang Cancer Hospital, as the external validation cohort.
SYSU cohort	Radio-score	Patients cohort from Sun Yat-sen Memorial Hospital, as the training cohort.

Primary Outcome Measures

Name	Time	Method
R0 resection	yes or not	In patients with advanced ovarian cancer, the residual status after initial cytoreductive surgery is defined as follows: complete resection is defined as R0 resection, whereas visible residual tumor lesions during surgery are defined as non-R0 resection

Secondary Outcome Measures

Name	Time	Method
Response to platinum-based chemotherapy	At least 6 months after the last chemotherapy	After the last chemotherapy, treatment efficacy was assessed according to NCCN guidelines. For primary tumor, patients who relapsed 6 months or more after initial chemotherapy were termed platinum-sensitive. In contrast, patients whose disease recurred in less than 6 months were classified as platinum-resistant.
5-year progression-free survival (PFS)	5 years	PFS was calculated from the date of the last chemotherapy until disease progression or death due to any cause.
5-year overall survival (OS)	5-year	OS was calculated from the date of the primary debulking surgery until death due to any cause.

Trial Locations

Locations (1)

The Sun Yat-sen Memorial Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China