RecruitingNCT06965166

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

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


Sponsor

Mayo Clinic

Enrollment

120 participants

Start Date

Oct 7, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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)

Interventions

PROCEDUREPCD-CT

Participants undergo PCD-CT scan on study


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT06965166


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