NCT05532930

An Exploratory Study of Using Magnetic Resonance Prognostic Imaging Markers for Radiotherapy In Patients With Cervix Cancer (EMPIRIC Study)

An Exploratory Study of Using Magnetic Resonance Prognostic Imaging Markers for Radiotherapy In Patients With Cervix Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: East and North Hertfordshire NHS Trust · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

Summary

Patients with cervical cancer that has not spread to other parts of the body can be cured with radiotherapy. One of the reasons radiotherapy can fail is because there are areas within the tumour that have a poor oxygen supply which makes them resistant to radiotherapy. This study aims to assess if it is feasible using special types of magnetic resonance imaging (MRI) - multi-parametric (MP) MRI to identify areas of low oxygen within the tumour so a higher dose of radiation can be given specifically to these areas to overcome the resistance and potentially improve cure rates without increasing side effects.

Detailed description

The study is an early exploratory study which will use MP MRI to predict which patients with locally advanced cervical cancer are likely to respond less well to chemoradiotherapy treatment, identify those patients and then intervene. Hypoxia (deprivation of oxygen supply at tissue level) has long been shown to be a major cause of radiation resistance in various tumour sites and has been shown to be a harmful factor in cervical cancer and is associated with poor outcomes for patients. The aim of the study is to scan patients using different MP MRI sequences, each of which will measure different things, including blood flow, tumour necrosis and oxygen levels to determine hypoxia. This will be the first study to use the 3 different types of MRI scan (Diffusion Weighted - DWI, Dynamic Contrast Enhanced - DCE and Blood Oxygen Level Dependent - BOLD) at 3 different time points during the whole course of chemoradiotherapy. The first scans will be prior to chemoradiotherapy treatment, the second set will be in week 2 and the final set in week 5. The imaging parameters from the MP MRI scans will be used as a surrogate markers of hypoxia. If high levels of hypoxia is identified using MP MRI, a prognostic imaging biomarker model can be developed to predict treatment outcomes of patients with locally advanced cervical cancer after chemoradiotherapy. This study has potential to benefit all patients with locally advanced cervical cancer undergoing radical radiotherapy through the provision of more robust risk stratification. Improved risk stratification will result in more personalised treatment of better quality leading potentially to more cures and less side effects. As reported by Cancer Research UK, 3200 women are diagnosed with cervical cancer each year in the UK. 40% of these women are treated with radical radiotherapy, all of whom may benefit from the outputs of this study.

Conditions

• Cervical Cancer

Timeline

• Start date: 2022-08-05
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2022-09-08
• Last updated: 2022-09-08

Locations

1 site across 1 country: United Kingdom