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RecruitingObservational

Pilot Prospective Study of Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer

NCT ID: NCT06965166Sponsor: Mayo ClinicLast updated: 2026-04-22

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

Sex: AllAge: 18 Years to 99 YearsHealthy volunteers: No
Inclusion Criteria: * Adult patients 18 to 99 years of age * Patients with proven rectal cancer clinically referred for staging pelvic MRI and contrast-enhanced CT of the abdomen and pelvis (for evaluation of liver and peritoneal disease) * Endoscopic or imaging report that tumor is 2 cm or larger * Patients who are able and willing to sign the informed consent * Negative pregnancy test if subject is of child-bearing age (females of child-bearing potential will be screened for pregnancy using a urine pregnancy test, which will be administered by the unit study coordinator at no cost to the patient) Exclusion Criteria: * Minors less than 18 years old * Patient unable to provide written informed consent * Pregnancy * Estimated Glomerular Filtration Rate (eGFR) ≤ 60 * History of prior moderate or severe contrast reaction including unresponsiveness, severe respiratory distress, convulsions, arrhythmia, cardiopulmonary distress, progressive angioedema, laryngeal edema, dyspnea, bronchospasm, symptomatic tachycardia, symptomatic bradycardia, hypotension, hypertensive crisis * Any history of premedication prior to iodinated contrast * Bilateral hip replacement/prosthesis * Patients that consent to participation but do not undergo their clinically indicated MRI scanning for any reason (e.g., bad IV, infiltration, reaction, change in indication)

Study locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Recruiting
Clinical Trials Referral Office · Contact
Boleyn Andrist · Contact
Joel G. Fletcher, MD · Principal Investigator
Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer | Cancerify