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

Satisfactory Debulking Prediction Model for Advanced Ovarian Cancer Based on PET-CT Image Data and Its Clinical Application

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06533709
Enrollment
146
Registered
2024-08-01
Start date
2024-06-01
Completion date
2026-05-31
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Image, Ovarian Cancer, Predation

Keywords

Ovarian Cancer, PET-CT Image, Debulking Prediction Model

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.

Interventions

DIAGNOSTIC_TESTRadio-score

A score based on the LASSO regression model predicting the R0 resection of the primary debulking surgery of advanced ovarian cancer.

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
R0 resectionyes or notIn 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

MeasureTime frameDescription
5-year progression-free survival (PFS)5 yearsPFS was calculated from the date of the last chemotherapy until disease progression or death due to any cause.
5-year overall survival (OS)5-yearOS was calculated from the date of the primary debulking surgery until death due to any cause.
Response to platinum-based chemotherapyAt least 6 months after the last chemotherapyAfter 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.

Countries

China

Contacts

Primary ContactHuaiwu Lu
luhuaiwu@mail.sysu.edu.cn86+ 18688395806
Backup ContactDongdong Ye
yedd3@mail2.sysu.edu.cn86+ 15218054426

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026