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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT04893434
Eligibility Criteria:
Inclusion Criteria:
Healthy volunteers (for SA1) will be entered into the study if they meet the following criteria:
* Women aged 18 years or older.
* Willing and able to provide informed consent
Patients (for SA2) will be entered into the study if they meet the following criteria:
* Women aged 18 years or older.
* Gynecologic cancer undergoing standard of care pelvic MRI prior to treatment
* Planned treatment with chemoradiation (for SA2b only)
* Willing and able to provide informed consent and adhere to the study visit schedule and plan as specified in this protocol.
Exclusion Criteria:
Healthy volunteers (SA1) and patients (SA2) exclusion criteria:
* History of allergic reactions to gadolinium-based contrast agents (GBCAs)
* Women of childbearing potential (WOCBP) must not be pregnant.
* Women must not be breastfeeding.
* Contraindications/risk factors to 3T MRI as per assessed by our departmental "Comprehensive MRI Screening Questionnaire" and "MRI Contrast Dye Questionnaire" (e.g. risk factors associated with magnetic field such as cardiac pacemakers, defibrillators or other devices as per standard institutional policy; and risk factors associated with GBCM such as diabetes, dialysis, breastfeeding)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04893434
Study Brief:
Protocol Section:
NCT04893434