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| ID | Type | Description | Link |
|---|---|---|---|
| 24-001797 | Other Identifier | Mayo Clinic Institutional Review Board |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients undergo PCD-CT on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCD-CT | Procedure | Participants undergo PCD-CT scan on study |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (after research CT scan has been performed) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with proven rectal cancer clinically referred for staging pelvic MR and contrast-enhanced CT of the abdomen and pelvis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu | |
| Boleyn Andrist | Contact | 507-538-7752 | andrist.boleyn@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joel G. Fletcher, MD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |