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 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT06475066
Eligibility Criteria:
Inclusion Criteria:
* 1\. Adult women aged 18-75 years old
* 2\. First-time referral to the breast clinic or inpatient department of the study center for being diagnosed as presenting with suspicious breast lesions by previous procedures in 30 days
* 3\. Presenting with Index lesions of "BI-RADSā„4" and additional findings in preoperative breast MRI
* 4\. Sign the informed consent form for this study.
* 5\. Commit to follow the research procedures and cooperate with the implementation of the whole process of the study.
* 6\. In the case of women of childbearing age, have been taken contraception for at least one month prior to screening and have had a negative serum or urine pregnancy test and commit to use contraception throughout the study period
Exclusion Criteria:
* 1\. Patients with contraindications of intravenous administration of iodine contrast agent, such as pregnant or lactating women, patients with a history of iodine contrast agent allergy, patients with obvious hyperthyroidism
* 2\. It has been more than 14 days since the most recent preoperative breast MRI was performed for the relevant breast disease
* 3\. For the relevant breast disease, the preoperative breast MRI images and reports received within 14 days before screening are not available or do not meet the requirements of clinical diagnosis
* 4\. Patients who is receiving non-surgical interventional treatment such as neoadjuvant chemotherapy, hormone therapy or radiation therapy
* 5\. Patients who have received any breast operation for the relevant disease, such as various biopsies, therapeutic breast surgery
* 6\. Other patients assessed by the investigators as not suitable for the study, such as those who are difficult to cooperate with CESM examination due to unconsciousness, communication disorder or/and small breasts to meet the examination requirements
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06475066
Study Brief:
Protocol Section:
NCT06475066