Status:
RECRUITING
Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer
Lead Sponsor:
Mayo Clinic
Conditions:
Rectal Carcinoma
Eligibility:
All Genders
18-99 years
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 ...
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
- 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)
Key Trial Info
Start Date :
October 7 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06965166
Start Date
October 7 2024
End Date
December 31 2026
Last Update
October 22 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905