Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer

Mayo Clinic

Status

Enrolling

Conditions

Rectal Carcinoma

Treatments

Procedure: PCD-CT

Study type

Observational

Funder types

Other

Identifiers

NCT06965166

NCI-2024-10472 (Registry Identifier)

24-001797 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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)