Rectal Carcinoma
Conditions
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.
Interventions
PROCEDUREPCD-CT
Participants undergo PCD-CT scan on study
Sponsors
Mayo Clinic
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-inferiority of contrast-enhanced pelvic PCD-CT for CRM involvement | Baseline (after research CT scan has been performed) | Images from contrast-enhanced pelvic PCD-CT for circumferential resection margin (CRM) involvement will be compared to rectal cancer MRI images. A single-group design will be used to test whether the proportion is non-inferior, with a noninferiority difference (P0 - PB) of -0.1 (H0: P ≤ P0 versus H1: P \> P0). The comparison will be made using a one-sided, one-sample exact binomial test, with a Type I error rate (alpha) of 0.05. The limit of non-inferiority will be set at -0.10, meaning that the lower limit of the estimate of the difference between the modalities will be greater than -0.10 for PCD-CT to be non-inferior. |
Countries
United States
Contacts
Primary ContactClinical Trials Referral Office
Backup ContactBoleyn Andrist
Outcome results
None listed