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 @ 2:17 PM
Ignite Modification Date:
2025-12-24 @ 2:17 PM
NCT ID:
NCT03542695
Eligibility Criteria:
Inclusion Criteria:
* Evidence of calcifications on mammogram
* Biopsy confirmed malignancy associated calcifications in at least one breast
* Biopsy confirmed benign calcifications in at least one breast (same or contralateral breast)
* Planned total mastectomy for treatment
* Ability to provide informed consent
* Negative serum pregnancy test
* No evidence of impaired hepatic or kidney function
Exclusion Criteria:
* Participants who do not have residual calcifications present on mammogram following biopsy
* Concurrent malignancy other than non-melanoma skin cancer
* Patients with known metastatic disease
* Patients who have received prior treatment for the current breast cancer
* Patients currently using oral bisphosphonate therapy
* Patients with injection of other radioactive material within 90 days
* Inability to provide informed consent
* Pregnant or lactating patients
* Patients with impaired kidney function (creatinine \>= 1.3 mg/dL or \< 0.6 mg/dL)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03542695
Study Brief:
Protocol Section:
NCT03542695