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

NCT06533709RecruitingOBSERVATIONAL

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.

Key Facts

Lead Sponsor

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

Enrollment

146

Start Date

2024-06-01

Completion Date

2026-05-31

Study Type

OBSERVATIONAL

Official Title

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

Interventions

Radio-score

Conditions

Ovarian CancerImagePredation

Eligibility

Age Range

18 Years – 80 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

R0 resection

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

Time frame: yes or not

Secondary Outcomes

5-year progression-free survival (PFS)

PFS was calculated from the date of the last chemotherapy until disease progression or death due to any cause.

Time frame: 5 years

5-year overall survival (OS)

OS was calculated from the date of the primary debulking surgery until death due to any cause.

Time frame: 5-year

Response to platinum-based 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.

Time frame: At least 6 months after the last chemotherapy

Locations

The Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, China

Linked Papers

2022-08-18

Preoperative PET/CT score can predict incomplete resection after debulking surgery for advanced serous ovarian cancer better than CT score, MTV, tumor markers and hematological markers

AbstractIntroductionComplete resection after debulking surgery is strongly associated with prolonged survival for advanced serous ovarian cancer (ASOC). Though positron emission tomography/computed tomography (PET/CT) is more advantageous than computed tomorgraphy (CT) for detecting metastases, studies on the PET/CT prediction model for incomplete resection for ovarian cancer are insufficient. We analyzed and compared the predictive value of preoperative PET/CT score, CT score, metabolic parameters, tumor markers and hematological markers for incomplete resection after debulking surgery for ASOC.Material and methodsA total of 62 ASOC patients who underwent preoperative [18F]FDG PET/CT and debulking surgery were retrospectively analyzed. PET/CT and CT scores were based on the Suidan model. The predictive value of PET/CT score, CT score, the maximum standardized uptake value (SUVmax), metabolic tumor volume (MTV), human epididymis protein 4 (HE4), cancer antigen 125 (CA125), lymphocyte‐to‐monocyte ratio (LMR), platelet‐to‐lymphocyte ratio (PLR) and neutrophil‐to‐lymphocyte ratio (NLR) for incomplete resection were analyzed and compared.ResultsPreoperative PET/CT score had the highest predictive value for incomplete resection in primary debulking surgery group (sensitivity: 65.0%, specificity: 88.9%, area under the ROC curve (AUC): 0.847, p < 0.001), however, in secondary debulking surgery group, preoperative PET/CT score and CT score had the same and highest predictive value for incomplete resection (sensitivity: 80.0%, specificity: 94.7%, AUC: 0.853, p = 0.017), compared with preoperative metabolic parameters SUVmax and MTV, tumor markers HE4 and CA125, and hematological markers LMR, PLR and NLR. Preoperative PET/CT score ≥ 3 (Suidan model) and preoperative PET/CT score ≥ 2 predicted a high risk of incomplete resection after primary and secondary debulking surgeries, respectively. There was no statistical difference between primary and secondary debulking surgery groups in predictive value of PET/CT score for incomplete resection (p = 0.971). There were significant differences between PET/CT scores and CT scores in primary debulking surgery group and no significant differences in secondary debulking surgery group.ConclusionsA high PET/CT score predicted a high risk of incomplete resection. The preoperative PET/CT score had an identical predictive value in primary and secondary debulking surgery groups. PET/CT score was more accurate in the detection of metastases than CT score was.

Linked Investigators

Yongmei Li