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

NCT05532930 | Recruiting

• 1 other identifier: RD2021-29
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• To determine if multi-parametric MRI (MP MRI) can be used to predict progression-free survival of patients with locally advanced cervical cancer after chemoradiotherapy.

  Progression-free survival measured by number of patients with local, distant and nodal progression

  1 and 2 years

• To determine if multi-parametric MRI (MP MRI) can be used to predict overall survival of patients with locally advanced cervical cancer after chemoradiotherapy.

  Overall survival measured by number of patients with overall survival

  1 and 2 years

Secondary Outcomes (1)

• Temporal changes in MP MR parameters during chemoradiotherapy and the identification of a prognostic imaging biomarkers.

  2 years

Other Outcomes (1)

• Molecular markers correlated with imaging parameters and evaluated independently and in combination with respect to prognostic impact.

  2 years

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female participants
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with locally advanced cervical cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• East and North Hertfordshire NHS Trust: lead
• University of Manchester: collaborator
• Brunel University: collaborator

Study Sites (1)

Mount Vernon Cancer Centre

Northwood, United Kingdom

RECRUITING

Related Publications (1)

• Abdul-Latif M, Chowdhury A, Tharmalingam H, Taylor NJ, Lakhani A, Padhani A, Hoskin P, Tsang Y. Exploratory study of using Magnetic resonance Prognostic Imaging markers for Radiotherapy In Cervix cancer (EMPIRIC): a prospective cohort study protocol. BMJ Open. 2024 Apr 18;14(4):e077390. doi: 10.1136/bmjopen-2023-077390.

  PMID: 38637128 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tumour tissue samples at diagnosis and point of brachytherapy Peripheral blood samples

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Yat Man Tsang

CONTACT

02038262624; yatmantsang@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 8, 2022
• Study Start: August 5, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)