A Radiomic MRI Predictive Model for Response to Concomitant Chemoradiotherapy in Locally Advanced Cervical Cancer

NCT07305727RecruitingOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrollment

120

Start Date

2026-01-01

Completion Date

2026-08-01

Study Type

OBSERVATIONAL

Official Title

Developing a Radiomic MRI Model Predictive of Response to Concomitant Chemoradiotherapy in Locally Advanced Cervical Cancer. A Prognostic, Retrospective, Open-label, Multicenter, Descriptive and Analytical Clinical Cohort Study

Conditions

Uterine Cervical NeoplasmsCervical Cancer by FIGO Stage 2018

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Patients treated with exclusive radio-chemotherapy for locally advanced cervical cancer (stage Ib-IVb according to the FIGO classification).
* Patients with a minimum of 2 years of post-treatment follow-up.
* Patients for whom the initial biopsy specimen (prior to treatment) is available.
* Patients who have not expressed their opposition to participating in the study.
* Patients who are affiliated with or beneficiaries of a health insurance plan.

Exclusion Criteria:

* Patients under judicial protection, guardianship, or curatorship

Outcome Measures

Primary Outcomes

Prognostic role of a magnetic resonance imaging radiomic model on progression-free survival in patients treated for locally advanced cervical cancer.

Time from diagnosis to death from any cause or progression (according to RECIST v1.1 criteria) at 24 months of follow-up.

Time frame: Month 24

Secondary Outcomes

Prognostic role of an magnetic resonance imaging radiomic model on overall survival in patients treated for locally advanced cervical cancer.

Time between treatment initiation and death from any cause at 24 months of follow-up.

Time frame: Month 24

Correlation between the radiomic magnetic imaging radiomic model and Programmed cell Death protein 1 (PD-L1) expression.

Collection of Programmed cell Death protein 1 (PD-L1) expression levels from biopsies from the EPICOL cohort.

Time frame: Month 24

Correlation between the radiomic magnetic resonance imaging model and tumor-infiltrating lymphocytes (TILs).

Collection of tumor-infiltrating lymphocyte (TIL) expression levels in biopsies from the EPICOL cohort.

Time frame: Month 24

Locations

Nimes University Hospital, Nîmes, France

Linked Papers

2023-10-02

Radiomics systematic review in cervical cancer: gynecological oncologists’ perspective

Radiomics is the process of extracting quantitative features from radiological images, and represents a relatively new field in gynecological cancers. Cervical cancer has been the most studied gynecological tumor for what concerns radiomics analysis. The aim of this study was to report on the clinical applications of radiomics combined and/or compared with clinical-pathological variables in patients with cervical cancer. A systematic review of the literature from inception to February 2023 was performed, including studies on cervical cancer analysing a predictive/prognostic radiomics model, which was combined and/or compared with a radiological or a clinical-pathological model. A total of 57 of 334 (17.1%) screened studies met inclusion criteria. The majority of studies used magnetic resonance imaging (MRI), but positron emission tomography (PET)/computed tomography (CT) scan, CT scan, and ultrasound scan also underwent radiomics analysis. In apparent early-stage disease, the majority of studies (16/27, 59.3%) analysed the role of radiomics signature in predicting lymph node metastasis; six (22.2%) investigated the prediction of radiomics to detect lymphovascular space involvement, one (3.7%) investigated depth of stromal infiltration, and one investigated (3.7%) parametrial infiltration. Survival prediction was evaluated both in early-stage and locally advanced settings. No study focused on the application of radiomics in metastatic or recurrent disease. Radiomics signatures were predictive of pathological and oncological outcomes, particularly if combined with clinical variables. These may be integrated in a model using different clinical-pathological and translational characteristics, with the aim to tailor and personalize the treatment of each patient with cervical cancer.

2022-03-24

Radiomics-based prediction of two-year clinical outcome in locally advanced cervical cancer patients undergoing neoadjuvant chemoradiotherapy

Abstract Purpose The aim of this study is to determine if radiomics features extracted from staging magnetic resonance (MR) images could predict 2-year long-term clinical outcome in patients with locally advanced cervical cancer (LACC) after neoadjuvant chemoradiotherapy (NACRT). Materials and methods We retrospectively enrolled patients with LACC diagnosis who underwent NACRT followed by radical surgery in two different institutions. Radiomics features were extracted from pre-treatment 1.5 T T2w MR images. The predictive performance of each feature was quantified in terms of Wilcoxon–Mann–Whitney test. Among the significant features, Pearson correlation coefficient (PCC) was calculated to quantify the correlation among the different predictors. A logistic regression model was calculated considering the two most significant features at the univariate analysis showing the lowest PCC value. The predictive performance of the model created was quantified out using the area under the receiver operating characteristic curve (AUC). Results A total of 175 patients were retrospectively enrolled (142 for the training cohort and 33 for the validation one). 1896 radiomic feature were extracted, 91 of which showed significance (p < 0.05) at the univariate analysis. The radiomic model showing the highest predictive value combined the features calculated starting from the gray level co-occurrence-based features. This model achieved an AUC of 0.73 in the training set and 0.91 in the validation set. Conclusions The proposed radiomic model showed promising performances in predicting 2-year overall survival before NACRT. Nevertheless, the observed results should be tested in larger studies with consistent external validation cohorts, to confirm their potential clinical use.

A Radiomic MRI Predictive Model for Response to Concomitant Chemoradiotherapy in Locally Advanced Cervical Cancer