Cervical CancerEMPIRICNCT05532930
An Exploratory Study of Using Magnetic Resonance Prognostic Imaging Markers for Radiotherapy In Patients With Cervix Cancer (EMPIRIC Study)
An observational study of Cervical Cancer, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Aug 2022to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Participants with locally advanced cervical cancer
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Mount Vernon Cancer Centre
Northwood
Yat Man Tsang, 02038262624
Yat Man Tsang
About this study
Official title: An Exploratory Study of Using Magnetic Resonance Prognostic Imaging Markers for Radiotherapy In Patients With Cervix Cancer
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.
Read the 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
- Medical subject headings
- Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 and 2 years
Secondary outcomes (1)
Temporal changes in MP MR parameters during chemoradiotherapy and the identification of a prognostic imaging biomarkers.
Parameters measured: Extravascular extracellular space volume fraction Ve (%), Transfer constant Ktrans (min-1), Rate Constant kep (min-1), Blood volume fraction vp (%), Apparent diffusion coefficient ADC (um2/sec), BOLD-based reversible transverse relaxation rate R2* (sec-1), Relaxation times (sec-1), 2nd order Haralick textural radiomic features
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start5 Aug 2022
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Manchester, Brunel University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532930
- Sponsor's protocol ID
- RD2021-29
- Acronym
- EMPIRIC
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38637128
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Using Magnetic Resonance Prognostic Imaging Markers for Radiotherapy In Patients With Cervix Cancer
- ClinicalTrials.gov ID
- NCT05532930
- Acronym / sponsor ID
- EMPIRIC / RD2021-29
- Conditions
- Cervical Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Collaborators
- University of Manchester, Brunel University
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Participants with locally advanced cervical cancer
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 1 and 2 years
Progression-free survival measured by number of patients with local, distant and nodal progression
To determine if multi-parametric MRI (MP MRI) can be used to predict overall survival of patients with locally advanced cervical cancer after chemoradiotherapy.
Time frame: 1 and 2 years
Overall survival measured by number of patients with overall survival
1 secondary outcome
Temporal changes in MP MR parameters during chemoradiotherapy and the identification of a prognostic imaging biomarkers.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Derived from this study: PubMed 38637128Abdul-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yat Man Tsang (02038262624, yatmantsang@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 and 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05532930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.