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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Carcinoma
• Intervention / Treatment: Procedure: PCD-CT

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Boleyn Andrist; Phone Number: 507-538-7752; Email: andrist.boleyn@mayo.edu
• Study Contact Backup: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Boleyn Andrist; Phone Number: 507-538-7752; Email: andrist.boleyn@mayo.edu
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Joel G. Fletcher, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with proven rectal cancer clinically referred for staging pelvic MR and contrast-enhanced CT of the abdomen and pelvis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; Patients undergo PCD-CT on study.	Procedure: PCD-CT; Participants undergo PCD-CT scan on study; Other Names: contrast-enhanced photon-counting detector CT; contrast-enhanced photon-counting detector computed tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (after research CT scan has been performed)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Joel G. Fletcher, MD, Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 1, 2025
• First Submitted That Met QC Criteria: May 1, 2025
• First Posted (Actual): May 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: 24-001797 (Other Identifier: Mayo Clinic Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No