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 @ 11:58 AM
Ignite Modification Date:
2025-12-24 @ 11:58 AM
NCT ID:
NCT02611661
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of colorectal carcinoma with intrahepatic metastases; limited extrahepatic metastasis is allowed as long as the overall metastatic burden is hepatic dominant.
* Local surgical resection is not possible due to tumor or patient factors.
* Prior locoregional therapy is allowed if completed at least 2 weeks prior to enrollment.
* Prior chemotherapy is allowed if stopped/completed at least 2 weeks prior to enrollment.
* At least 18 years old.
* ECOG performance status ≤ 1.
* Scheduled to undergo radioembolization for treatment of intrahepatic metastases.
* Able to understand and willing to sign an IRB-approved written informed consent document.
Exclusion Criteria:
* Child-Pugh score 8 or greater.
* ALT or AST ≥ 6 x ULN.
* Prior history of abdominal irradiation. Patients who have received prior pelvic radiation for colorectal cancer are eligible; however, prior radiation treatment plans must be reviewed prior to enrollment.
* Presence of any contraindications to MRI scanning.
* GFR \< 30 ml/min/1.73m2 (if receiving contrast for MRI).
* Currently on dialysis (if receiving contrast for MRI).
* Prior allergic reaction to gadolinium-based contrast agents (if receiving contrast for MRI).
* Pregnant or nursing. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02611661
Study Brief:
Protocol Section:
NCT02611661