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Observational Study of PCD-CT for Rectal Cancer Staging

This study is looking at whether a special type of CT scan, called a photon-counting detector CT (PCD-CT), can be as good as or better than an MRI for checking how much rectal cancer has grown. Researchers want to see if PCD-CT can accurately show if the cancer has spread to the circumferential resection margin (CRM), which is important for treatment planning. You might be able to join if you are an adult between 18 and 99 years old with confirmed rectal cancer that is 2 cm or larger, and you are already scheduled for a pelvic MRI and a contrast-enhanced CT scan. The study aims to enroll 200 participants. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 200 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will undergo a PCD-CT scan as part of the study. The record does not specify additional visits or procedures.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Baseline, after the research CT scan has been performed. No further follow-up is specified.

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NCT06965166

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

Recruiting
Not specifiedAges 18–99Observational
Mayo Clinic
~200 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:PCD-CT

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Non-inferiority of contrast-enhanced pelvic PCD-CT for CRM involvement
Measured over Baseline (after research CT scan has been performed)

Conditions

Rectal Carcinoma

Explore related trials

Rectal Carcinoma

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Joel G. Fletcher, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Non-inferiority of contrast-enhanced pelvic PCD-CT for CRM involvementBaseline (after research CT scan has been performed)

    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.