Clinical trial NCT06877065: Role of MRI Assessment in Fertility Sparing Treatment for Cervical Cancer at Staging and Follow-up and for Identification of Risk Factors for Aggressive Disease.
Official title: Role of MRI Assessment in Fertility Sparing Treatment for Cervical Cancer at Staging and Follow-up and for Identification of Risk Factors for Aggressive Disease.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Candidate patients will be enrolled among those with cervical cancer, according to inclusion criteria. They will be informed about the possibility of being enrolled in this study during the outpatient clinics/hospitalization examination and will be given an adequate description of this study (objectives of the study, what the participation involves, possible risks and benefits, what the non- participation may entail, possibility of interruption, etc.). In case of enrolment, an informed consent including acceptance to make available the anonymized personal, clinical-laboratory and diagnostic imaging data will be signed.

Brief summary: The purpose of this study is to investigate the role of MRI, including DWI, in the staging and evaluation of response to fertility sparing treatment, including both primary surgery Protocol FeST-CC V.1.0 of November 10, 2023 Pag. 5 \| 23 (RT or CKC) or after NACT, followed by CKC, in patients with ECC (FIGO 2018 stage IB1- IIA1), desiring to preserve their fertility.

Detailed description: Cervical cancer represents the fourth-most common cancer in women and the leading gynaecologic malignancies, accounting approximately 570,000 cases and 311,000 deaths in 2018 worldwide. In Europe, during last years, both mean age of pregnant women and number of nulliparous women have increased (2). Age-specific incidence data indicate that 43% of patients with cervical cancer have less than 45 years. As consequence, numerous young women diagnosed with cervical cancer are still desiring to become pregnant.

In women with early-stage cervical cancer (ECC), fertility-sparing surgery techniques include laparoscopic, abdominal or vaginal radical trachelectomy (RT) and cold knife conization (CKC) with or without pelvic lymph nodes dissection. Currently, RT is proposed as fertility-sparing surgery (FSS), alternative to radical hysterectomy, in patients with ECC staged IA1-IB1, as by the 2018 International Federation of Gynecology and Obstetrics (FIGO) classification. According to a recent metanalysis, RT and CKC present similar oncologic outcomes in terms of recurrence rates but CKC presents better obstetrical outcomes in terms of pregnancy rate (36% for CKC vs. 20% for RT) . NCCN suggested RT as an alternative to radical hysterectomy (RH) in young women desiring to preserve fertility with: disease limited to cervix, tumor size \< 2 cm (or \< 2.5 cm if exophytic lesion), absence of parametrial extension, an estimated distance of ≥ 1 cm from the proximal aspect of the tumor to the internal os, absence of lymphadenopathies or metastatic disease. Some authors have proposed neoadjuvant chemotherapy (NACT) followed by CKC as a safe and effective approach in ECC FIGO stage IB2.

In 2018 FIGO staging was revised allowing the use of any of the imaging modalities (i.e.

ultrasound, CT, MRI, positron emission tomography (PET)), to provide information on tumor size, nodal status, and local or systemic spread. MRI is reported to be very accurate in selecting patients eligible for FSS, in tumor size evaluation and deep stromal invasion assessment. In the evaluation of parametrial invasion, the specificity and negative predictive value of MRI were 97% and 100%, respectively.

Furthermore, MRI has demonstrated very high sensitivity and specificity in assessment of internal os involvement, 90% and 98% respectively. Moreover, MRI including diffusion-weighted imaging (DWI) assumes an important role in the evaluation of tumor response after chemotherapy. In addition, MRI is highly sensitive and accurate (90.7% and 91.7% respectively) in tumor size evaluation after FSS, especially in patients who have undergone cone biopsy before MRI examination.

The purpose of this study is to investigate the role of MRI, including DWI, in the staging and evaluation of response to fertility sparing treatment, including both primary surgery (RT or CKC) or after NACT, followed by CKC, in patients with ECC (FIGO 2018 stage IB1- IIA1), desiring to preserve their fertility.

Eligibility criteria: Inclusion Criteria:

* Patients with cervical cancer FIGO stage up to IB2-IIA1 (T size \< 4 cm) wishing to preserve fertility treated at the Oncological Gynecology Unit of Foundation Policlinico Universitario Agostino Gemelli.
* absence of nodal disease,
* no menopausal status
* wish to preserve fertility
* refusal of radical treatment.
* Patients who had a pre-treatment and post-treatment magnetic resonance imaging.
* Availability of digital MR images and histopathological samples.

Exclusion Criteria:

* Patients aged under 18 years.
* Neuroendocrine cervical tumours or other rare histology, such as glassy cells or clear cell carcinoma non-HPV related adenocarcinoma.
* ongoing pregnancy at the time of diagnosis.
* Patients without available MR images on digital media or with low quality images.

Primary outcomes:
measure: MRI accuracy in preoperative staging of early stage cervical cancer for fertility-sparing treatment
timeFrame: 3 years
Secondary outcomes:
measure: The accuracy of MRI in evaluating treatment response after fertility-sparing treatment in cervical cancer, including specificity and sensibility
timeFrame: 3 years
measure: Assessment of MRI Parameter to predict more aggressive disease
timeFrame: 3 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Advanced Radiology Center- Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Benedetta Gui
role: PRINCIPAL_INVESTIGATOR
References: