Using MRI to Improve Radiotherapy for Cervical Cancer
An Exploratory Study of Using Magnetic Resonance Prognostic Imaging Markers for Radiotherapy In Patients With Cervix Cancer
This study is testing if special MRI scans can help doctors find areas in cervical cancer tumors that aren't getting enough oxygen to see if they can adjust treatment for better results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | East and North Hertfordshire NHS Trust Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Northwood) |
| Trial ID | NCT05532930 on ClinicalTrials.gov |
What this trial studies
This exploratory study aims to assess the feasibility of using multi-parametric MRI to identify areas of low oxygen supply within tumors in patients with locally advanced cervical cancer. By measuring blood flow, tumor necrosis, and oxygen levels at three different time points during chemoradiotherapy, the study seeks to predict which patients may respond poorly to treatment. The goal is to develop a prognostic imaging biomarker model that can guide higher radiation doses to resistant tumor areas, potentially improving cure rates without increasing side effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over with histologically confirmed locally advanced cervical cancer who are suitable for radical chemoradiation.
Not a fit: Patients with distant metastasis or previous pelvic malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes for patients with locally advanced cervical cancer undergoing radiotherapy.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using imaging to predict treatment outcomes in other cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed FIGO stage Ib2-IVa squamous, adeno or adenosquamous carcinoma of the cervix. * Clinically and/or radiographically documented measurable disease with at least one site of disease unidimensionally measurable as per RECIST 1.1 * All detectable disease including pelvic/para-aortic nodes encompassable within radical high-dose radiation field * Deemed suitable and fit for radical chemoradiation * ECOG performance status 0 - 1 * Aged 18 and over * Documented negative pregnancy test (if applicable) * Capable of providing written or witnessed informed consent according to ICH/GCP and national/local guidelines prior to registration Exclusion Criteria: * Previous pelvic malignancy (regardless of interval since diagnosis) * Previous malignancy not affecting the pelvis (except basal cell carcinoma of the skin) where disease free interval is less than 10 years * Evidence of distant metastasis i.e. any non-nodal metastasis beyond the pelvis * Previous pelvic radiotherapy * Prior diagnosis of Crohn's disease or Ulcerative colitis * Uncontrolled cardiac disease (defined as cardiac function which would preclude hydration during cisplatin administration) * Previous record of allergic reaction to Gadolinium-based contrast media and any other contra-indication to magnetic resonance imaging (MRI) * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study * Participation in any interventional trials
Where this trial is running
Northwood
- Mount Vernon Cancer Centre — Northwood, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Yat Man Tsang
- Email: yatmantsang@nhs.net
- Phone: 02038262624
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.