Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer (NCT06965166) | Clinical Trial Compass
RecruitingNot Applicable
Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer
United States200 participantsStarted 2024-10-07
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Non-inferiority of contrast-enhanced pelvic PCD-CT for CRM involvement
Timeframe: Baseline (after research CT scan has been performed)