Recruiting

PCD-CT

Sponsor:

Mayo Clinic

Code:

NCT06965166

Conditions

Rectal Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

PCD-CT

Study Details

Brief 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.

Conditions

Rectal Carcinoma

Study ID

NCT06965166

Start date

Oct 7, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients undergo PCD-CT on study.

Interventions

PCD-CT

Participants undergo PCD-CT scan on study

Primary outcome measure

  • Non-inferiority of contrast-enhanced pelvic PCD-CT for CRM involvement [ Time Frame: Baseline (after research CT scan has been performed) ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Boleyn Andrist

507-538-7752andrist.boleyn@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Boleyn Andrist

507-538-7752andrist.boleyn@mayo.edu

Principal Investigator:

Joel G. Fletcher, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-22.