Pilot Prospective Study of Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer
Summary
This study evaluates whether images taken using a photon counting detector CT scanner (PCD-CT) can determine the growth of rectal cancer as well as, or better than, MRI for the management of patients with rectal cancer.
Arms & interventions
- ProcedurePCD-CT
Participants undergo PCD-CT scan on study
Outcome measures
Primary
Non-inferiority of contrast-enhanced pelvic PCD-CT for CRM involvement
Images from contrast-enhanced pelvic PCD-CT for circumferential resection margin (CRM) involvement will be compared to rectal cancer MRI images. A single-group design will be used to test whether the proportion is non-inferior, with a noninferiority difference (P0 - PB) of -0.1 (H0: P ≤ P0 versus H1: P \> P0). The comparison will be made using a one-sided, one-sample exact binomial test, with a Type I error rate (alpha) of 0.05. The limit of non-inferiority will be set at -0.10, meaning that the lower limit of the estimate of the difference between the modalities will be greater than -0.10 for PCD-CT to be non-inferior.
Time frame: Baseline (after research CT scan has been performed)
Eligibility criteria
Study locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905