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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT05350059
Eligibility Criteria:
Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the trial.
* Female, aged 18 years or above.
* Histologically confirmed breast cancer (invasive ductal cancer) by core biopsy, which is suitable for surgical resection.
* Participants must have one non-metastatic, clinically palpable, invasive breast cancer measuring ≤2cm in its largest dimension, which can be visualised using diagnostic ultrasound.
* All participants must have an adequate biopsy determination of oestrogen, progesterone, HER2 receptor status on pre-operative biopsy.
* Adequate ECG, haematological, renal and hepatic function, as indicated, as would be required for imaging and surgery.
* In the Investigator's opinion, is able and willing to comply with all trial requirements.
Exclusion Criteria:
* Female participant who is pregnant.
* Significant renal or hepatic impairment.
* An inadequate biopsy determination of oestrogen, progesterone, HER2 receptor status on pre-operative biopsy.
* Unable to visualize lesion or tumour boundaries clearly on ultrasound.
* Subjects with tumours lying less than 5mm to overlying skin or less than 5mm to the underlying muscle on the diagnostic scan.
* Any uncontrolled illness or any other medical problem that would preclude surgery.
* The presence of any contraindication for magnetic resonance imaging, e.g. the presence of a heart pacemaker, a metallic foreign body (metal sliver) in the eye, or an aneurysm clip in the brain or severe claustrophobia.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05350059
Study Brief:
Protocol Section:
NCT05350059