Using MRI to assess fertility-sparing treatment for cervical cancer
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.
This study is testing how MRI can help women with early-stage cervical cancer who want to keep their ability to have children, by checking how well their fertility-sparing treatments are working.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rome) |
| Trial ID | NCT06877065 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of MRI, including diffusion-weighted imaging (DWI), in staging and evaluating the response to fertility-sparing treatments for early-stage cervical cancer. It focuses on patients desiring to preserve their fertility while undergoing treatments such as radical trachelectomy or cold knife conization. The study aims to identify risk factors for aggressive disease and assess the effectiveness of these treatments through pre- and post-treatment MRI evaluations. The research is conducted at the Oncological Gynecology Unit of Fondazione Policlinico Universitario Agostino Gemelli.
Who should consider this trial
Good fit: Ideal candidates are women with early-stage cervical cancer (FIGO stage IB1-IIA1) who wish to preserve their fertility and have undergone MRI imaging.
Not a fit: Patients under 18 years, those with rare histologies of cervical cancer, or those currently pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of cervical cancer in young women wishing to maintain their fertility.
How similar studies have performed: While the approach of using MRI in this context is gaining attention, the specific application in fertility-sparing treatments for cervical cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rome
- Advanced Radiology Center- Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Benedetta Gui — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Benedetta Gui
- Email: benedetta.gui@policlinicogemelli.it
- Phone: +390630158637
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.