Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer
ConditionRectal Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorMayo Clinic
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Minors less than 18 years old
Patient unable to provide written informed consent
Pregnancy
Estimated Glomerular Filtration Rate (eGFR) ≤ 60
Trial population
Patients with proven rectal cancer clinically referred for staging pelvic MR and contrast-enhanced CT of the abdomen and pelvis.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
PCD-CT
Procedure/SurgeryParticipants undergo PCD-CT scan on study
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Observational1 intervention
Trial outcomes
Primary outcomes
1
Non-inferiority of contrast-enhanced pelvic PCD-CT for CRM involvement
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.
Time frame
Baseline (after research CT scan has been performed)Sponsors and contacts
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Source ClinicalTrials.gov