Contrast-enhanced rectal photon-counting detector CT for the local staging of rectal cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 24-001797
Sponsor Protocol Number: 24-001797
About this study
The purpose of this study is to examine the capability of contrast-enhanced pelvic PCD-CT for local staging of rectal cancer, with dedicated rectal cancer staging MR serving as the reference standard and to determine the optimal high-resolution images (image type [T3D, low keV, iodine map, IR or denoising method] that should be reconstructed after PCD-CT image acquisition for rectal cancer detection and staging.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adult patients 18 to 99 years of age
-
Patients with proven rectal cancer clinically referred for staging pelvic MR and either:
*Scheduled for a clinically-indicated, contrast enhanced CT of the abdomen and pelvis (with or without a chest CT) or evaluation of liver and peritoneal disease; or
* Contrast-enhanced CT of the abdomen and pelvis (with or without a chest CT) performed within the last six weeks
- 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
- Rectal cancer that is mucinous adenocarcinoma (will not enhance well on CT)[FM1]
- Patients unable to provide written informed consent
- Pregnancy
- eGFR ≤ 60 (7, 8)
- 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 MR scanning for any reason (e.g., bad IV, infiltration, reaction, change in indication).
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 1/16/2025. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available