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:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT03940092
Eligibility Criteria:
Inclusion Criteria:
Healthy Volunteers
* Female, aged 18 years or above
* Participant is willing and able to give informed consent for participation in the study.
Patients
* Female, aged 18 years or above
* Pathologically confirmed primary breast cancer
* Tumour \>1 cm diameter on mammography and/or ultrasound.
Exclusion Criteria for healthy volunteers and patients:
* Pregnant or lactating;
* History of serious breast trauma within past 3 months
* Implants known to be contraindicated at 3T MRI
* Significant or uncontrolled medical problems which according to the opinion of the Principal Investigator render the participant unsuitable for participation in the study
* Underlying conditions, including but not limited to medical or psychiatric conditions, which in the opinion of the Principal Investigator would preclude the participant from adhering to the study protocol or completing the study per protocol
* Lacking the capacity to provide informed consent.
Additional exclusion criteria for patients
* Has undergone chemotherapy or hormonal therapy for breast cancer in the previous 12 months
* Previous surgery or radiotherapy for breast cancer to the ipsilateral breast within the past 4 months
* Previous surgery for benign breast disease within the past 4 months
* History of kidney disease or known allergic reaction to gadolinium contrast agent.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03940092
Study Brief:
Protocol Section:
NCT03940092