Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT05029258
Eligibility Criteria:
Inclusion criteria:
* Patients must have a histologically confirmed diagnosis of cervical cancer
* Diagnostic/pre-treatment biopsy available
* Patients must be suitable for standard radiotherapy and brachytherapy
* Age greater than or equal to 18 years; no upper age limit
* Performance status - ECOG 0-2 (Refer to appendix 1)
* Women of childbearing age MUST have a negative pregnancy test prior to study entry and be using an adequate contraception method
* Before participant registration, written informed consent must be given according to GCP and national regulations.
Exclusion criteria:
* Participants deemed unsuitable for a biopsy (during or following radiotherapy) in the opinion of the treating oncologist.
* Patients with cardiac pacemakers, cochlear implants, intraocular foreign bodies or any other MR contraindication
* Patients with a hip replacement
* Patients with a known history of allergic reaction to gadolinium-based contrast agent
* Any contraindications to Hyoscine Butylbromide (Buscopan)
* Any patient taking ACE inhibitors. These should be stopped/substituted or they are a contraindication.
* Evidence of impaired renal function (eGFR \<15 ml/min)
* Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the study
* Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the study
* Any other serious uncontrolled medical conditions
* Clinical evidence of metastatic disease
* Any pregnant or lactating woman
* Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
* Any patient who is currently involved in, or who has recently been involved in other research
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05029258
Study Brief:
Protocol Section:
NCT05029258