Contrast-enhanced rectal photon-counting detector CT for the local staging of rectal cancer

Overview

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 contrast-enhanced CT of the abdomen and pelvis (for evaluation of liver and peritoneal disease)
  • 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 2/15/2024. 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.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Joel Fletcher, M.D.

Open for enrollment

Contact information:

Boleyn Andrist CCRP

(507) 538-7752

Andrist.Boleyn@mayo.edu

More information

Publications

Publications are currently not available