Using advanced CT imaging to assess rectal cancer growth
Pilot Prospective Study of Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer
This study is testing a new type of CT scan to see if it can better track the growth of rectal cancer compared to regular MRI scans in adults who have been diagnosed with the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06965166 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of a photon counting detector CT scanner (PCD-CT) in determining the growth of rectal cancer compared to traditional MRI methods. Adult patients with confirmed rectal cancer who are referred for staging will undergo imaging with PCD-CT alongside standard contrast-enhanced CT and MRI. The goal is to assess whether PCD-CT can provide equal or superior imaging results for managing rectal cancer. The study aims to improve the accuracy of local staging in rectal cancer patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 99 with proven rectal cancer and tumors 2 cm or larger, who are referred for staging imaging.
Not a fit: Patients with known mucinous adenocarcinoma or those with significant renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate staging of rectal cancer, potentially improving treatment outcomes for patients.
How similar studies have performed: While the use of advanced imaging techniques is common, this specific approach with PCD-CT for rectal cancer staging is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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 * Bilateral 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)
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Joel G. Fletcher, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.