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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT05261633
Eligibility Criteria:
Inclusion Criteria for Healthy Volunteers:
* 18 years of age or older
Exclusion Criteria for Healthy Volunteers:
* Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, claustrophobia, etc)
* Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)
Inclusion Criteria for Patients:
* 18 years of age or older
* Patients with at least one of the following:
* Radiologically visible solid tumor liver metastasis, with at least one metastatic liver lesion must be a minimum of 8 mm in longest diameter
* Patients presenting for liver lesion biopsy
Exclusion Criteria for Patients:
* Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, claustrophobia, etc)
* Patients with known contraindication to GBCA such as severe kidney disease or previously documented GFR \< 30 ml/min/1.73 m2
* Patients requiring intravenous (IV) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the MRI will be allowed to participate as long as the following criteria are met:
* The subject has their own prescription for the medication.
* The informed consent process is conducted prior to the self-administration of this medication
* They come to the research visit with a driver
* Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)
* Stent in bile ducts
* Partial hepatectomy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05261633
Study Brief:
Protocol Section:
NCT05261633