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Recruiting NCT06965166

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

— Observational Rectal Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PCD-CT.
Who it may be relevant to
Registry conditions: Rectal Carcinoma. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure PCD-CT
    Participants undergo PCD-CT scan on study

Primary outcome measures

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

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06965166 · 24-001797 · 24-001797

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗