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:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT01609920
Eligibility Criteria:
Inclusion Criteria:
1. Female patient with histopathologically confirmed breast cancer about to undergo nodal staging.
2. Willing and able to undergo all study procedures
3. Has personally provided written informed consent.
Exclusion Criteria:
1. Age \<18,
2. Pregnancy
3. Contra indications for MRL such as pacemaker, aneurysm clips or severe claustrophobia.
4. Allergy to any of the ingredients of Gadofosveset (Vasovist® /Ablavar®)
5. Being unable to give informed consent in person
6. Acute or chronic severe renal insufficiency (glomerular filtration rate \<45 mL/min/1.73m2)1.
7. Acute renal insufficiency of any severity due to the hepato-renal syndrome.
8. Known (or suspicion of) QT- prolongation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01609920
Study Brief:
Protocol Section:
NCT01609920