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NCT06965166 | RECRUITING | Rectal Carcinoma

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

Mayo Clinic

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.

Condition or disease

Rectal Carcinoma

Intervention/treatment

PCD-CT

Study Type : OBSERVATIONAL
Estimated Enrollment : 120 participants
Official Title : Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer
Actual Study Start Date : 2024-10-07
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
  • * Known mucinous adenocarcinoma (may not enhance well)
  • * 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
  • * 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)
Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer

Location Details

NCT06965166

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905