Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer
Pilot Prospective Study of Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 99 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a special CT scanner called photon-counting CT can show how far rectal cancer has grown as well as, or better than, MRI. It is for adults with confirmed rectal cancer who have been referred for MRI and CT scans.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18 to 99 years old.
- You have confirmed rectal cancer and have been referred for a pelvic MRI and a CT scan with contrast dye of your belly and pelvis to check for cancer spread.
- A scope exam or scan report shows that your tumor is at least 2 cm wide.
- You are able and willing to sign a form agreeing to join the study.
- If you could become pregnant, you must have a negative urine pregnancy test. The study provides this test at no cost.
Who can't join
- You are younger than 18.
- You cannot give written consent to join the study.
- You are pregnant.
- Your eGFR, a measure of how well your kidneys filter blood, is 60 or lower.
- You have had a moderate or severe reaction to contrast dye, such as serious breathing trouble, seizures, swelling, or heart or blood pressure problems.
- You have ever taken medicine before receiving iodine-based contrast dye to help prevent a reaction.
- You have artificial joints in both hips.
- You agree to join but do not get your planned MRI scan for any reason.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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)
Study sites (1)
MN
- Mayo Clinic in Rochester · Rochester, MN 55905Clinical Trials Referral Office · Study contact · 855-776-0015 · mayocliniccancerstudies@mayo.eduBoleyn Andrist · Study contact · 507-538-7752 · andrist.boleyn@mayo.eduJoel G. Fletcher, MD · Principal investigatorMore trials in Rochester