Rectal CarcinomaNCT06965166
Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer
An observational study of Rectal Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Rectal Carcinoma
- What is being tested?
- PCD-CT
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with proven rectal cancer clinically referred for staging pelvic MR and contrast-enhanced CT of the abdomen and pelvis.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Boleyn Andrist, 507-538-7752, andrist.boleyn@mayo.edu
About this study
Official title: Pilot Prospective Study of Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer
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.
- Conditions
- Rectal Carcinoma
- Being tested
- PCD-CT
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCD-CTProcedure or surgery
Also called contrast-enhanced photon-counting detector CT, contrast-enhanced photon-counting detector computed tomography
Participants undergo PCD-CT scan on study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients undergo PCD-CT on study. Receives: Procedure: PCD-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of contrast-enhanced pelvic PCD-CT for CRM involvement
Images from contrast-enhanced pelvic PCD-CT for circumferential resection margin (CRM) involvement will be compared to rectal cancer MRI images. A single-group design will be used to test whether the proportion is non-inferior, with a noninferiority difference (P0 - PB) of -0.1 (H0: P ≤ P0 versus H1: P > P0). The comparison will be made using a one-sided, one-sample exact binomial test, with a Type I error rate (alpha) of 0.05. The limit of non-inferiority will be set at -0.10, meaning that the lower limit of the estimate of the difference between the modalities will be greater than -0.10 for PCD-CT to be non-inferior.
Measured: Baseline (after research CT scan has been performed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start7 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel G. Fletcher, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965166
- Sponsor's protocol ID
- 24-001797
- Other IDs
- 24-001797
- Status last verified
- Apr 2026
- First submitted
- 1 May 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Prospective Study of Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) for the Local Staging of Rectal Cancer
- ClinicalTrials.gov ID
- NCT06965166
- Acronym / sponsor ID
- 24-001797
- Conditions
- Rectal Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Procedure: PCD-CTPatients undergo PCD-CT on study. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with proven rectal cancer clinically referred for staging pelvic MR and contrast-enhanced CT of the abdomen and pelvis.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCD-CTAlso: contrast-enhanced photon-counting detector CT, contrast-enhanced photon-counting detector computed tomographyParticipants undergo PCD-CT scan on study | Procedure or surgery | Observational |
Primary outcome
Non-inferiority of contrast-enhanced pelvic PCD-CT for CRM involvement
Time frame: Baseline (after research CT scan has been performed)
Images from contrast-enhanced pelvic PCD-CT for circumferential resection margin (CRM) involvement will be compared to rectal cancer MRI images. A single-group design will be used to test whether the proportion is non-inferior, with a noninferiority difference (P0 - PB) of -0.1 (H0: P ≤ P0 versus H1: P > P0). The comparison will be made using a one-sided, one-sample exact binomial test, with a Type I error rate (alpha) of 0.05. The limit of non-inferiority will be set at -0.10, meaning that the lower limit of the estimate of the difference between the modalities will be greater than -0.10 for PCD-CT to be non-inferior.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joel G. Fletcher, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of contrast-enhanced pelvic PCD-CT for CRM involvement (time frame: Baseline (after research CT scan has been performed)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.