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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT04150705
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age
* Biopsy-proven rectal adenocarcinoma of the rectum with clinically suspected or previously known stage I-IIIB (cT1-4, N0-2, M0) disease
* Anticipated or prior chemoradiation as part of an NOM treatment strategy
* Ability to understand and willingness to sign an IRB-approved written informed consent document
Exclusion Criteria:
* Prior surgical resection of rectal cancer (endoscopic or TME)
* Contraindication to MRI
* Comorbidities that would limit patient's ability to cooperate with a PET/MRI examination (e.g. dementia, inability to follow commands, claustrophobia, tremors, requirement for oxygen by nasal cannula, etc…).
* Implanted devices or materials that may interfere with MRI imaging or create significant artifact
* Pregnancy
* Contraindication to gadolinium contrast or FDG
* End-stage renal disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04150705
Study Brief:
Protocol Section:
NCT04150705