Actively Recruiting

Age: 18Years - 99Years
All Genders
ID06965166

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

Led by Mayo Clinic · Updated on 2026-04-22

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether images taken using a photon counting detector CT scanner (PCD-CT) can detect the growth of rectal cancer as well as, or better than, MRI scans. The study focuses on patients with rectal cancer and aims to assess how well this newer CT technology can manage the disease compared to the current standard imaging method. Participants will undergo a contrast-enhanced pelvic PCD-CT scan, which is the main procedure being studied. This observational study involves patients who are already clinically referred for staging pelvic MRI and contrast-enhanced CT of the abdomen and pelvis. The study does not involve treatment but focuses on imaging to assist in cancer staging. During the study, participants will have the PCD-CT scan performed, and researchers will evaluate its ability to determine circumferential resection margin (CRM) involvement after the scan. This will help understand if PCD-CT is non-inferior to MRI in assessing rectal cancer growth. The study includes safety monitoring like pregnancy testing for women of childbearing potential and excludes participants with certain medical conditions. The trial runs until the end of 2026, with participant involvement focused on imaging and related assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients 18 to 99 years of age
  • Proven rectal cancer and referred for staging pelvic MRI and contrast-enhanced CT of the abdomen and pelvis
  • Tumor size 2 cm or larger as confirmed by endoscopy or imaging report
  • Able and willing to sign the informed consent
  • Negative pregnancy test for females of child-bearing potential
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Unable to provide written informed consent
  • Pregnancy
  • Estimated Glomerular Filtration Rate (eGFR) of 60 or less
  • History of moderate or severe allergic reaction to contrast
  • Prior premedication before iodinated contrast
  • Bilateral hip replacement or prosthesis
  • Consent given but do not undergo clinically indicated MRI for any reason

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Single timepoint

Participants undergo a contrast-enhanced photon-counting detector CT (PCD-CT) scan for local staging of rectal cancer.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

B

Boleyn Andrist

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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