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:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT06611306
Eligibility Criteria:
Inclusion Criteria
1. Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up
2. Adult (aged 16+) patients, resident in the United Kingdom.
3. Histologically confirmed primary breast cancer with brain metastases on MRI imaging
4. The treating oncologist considers whole-brain radiotherapy to be the most suitable treatment outside of the trial.
5. Eastern Cooperative Oncology Group Performance status 0, 1 or 2
6. Able to respond to question about their quality of life, symptoms, and side effects remotely (via telephone assessments
7. Life expectancy from extra-cranial disease \>3 months
Exclusion Criteria
1. Leptomeningeal disease
2. "Miliary" pattern of metastases: patients with over 15 metastases are excluded (clinician-based assessment)
3. Cystic metastases
4. Previous whole or partial brain radiotherapy (previous surgery or SRS is acceptable)
5. Plan for hippocampal-sparing whole brain radiotherapy.
6. Unable to give informed consent.
7. Prognosis less than 3 months
8. Pregnant or nursing women
9. Unable to complete a brain MRI and/or known allergy to gadolinium.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
100 Years
Study:
NCT06611306
Study Brief:
Protocol Section:
NCT06611306