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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The purpose of this study is to measure the diagnostic performance of whole body (WB) MR-PET for staging rectal cancer, compared with current standard of care (chest/abdominopelvic CT and rectal MRI) to investigate clinical feasibility of WB MR-PET as a one-stop preoperative imaging modality in patients with rectal cancer.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR-PET | Procedure | whole body MR-PET with dedicated liver+rectal protocol |
| Measure | Description | Time Frame |
|---|---|---|
| the concordance rate between rectal cancer staging performed by WB MR-PET and the current standard of care (chest/abdominopelvic CT and rectal MRI | the concordance rate between two protocols (standard protocol vs. WB-MR-PET) would be calculated. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of recommendation for further workup after examination | incidence of recommendation for further w/u after two protocols (standard vs. study) would be compared. | 12 months |
| concordance rate of clinical staging between standard of care and that obtained by combination of WB MR-PET and chest CT. |
| Measure | Description | Time Frame |
|---|---|---|
| Transient dyspnea | incidence of transient dyspnea which can occur after MR contrast agent administration and spontaneously regressed. | within an hour after MR contrast media administration |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients newly diagnosed with rectal cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Jeong Hee Yoon, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31793850 | Derived | Yoon JH, Lee JM, Chang W, Kang HJ, Bandos A, Lim HJ, Kang SY, Kang KW, Ryoo SB, Jeong SY, Park KJ. Initial M Staging of Rectal Cancer: FDG PET/MRI with a Hepatocyte-specific Contrast Agent versus Contrast-enhanced CT. Radiology. 2020 Feb;294(2):310-319. doi: 10.1148/radiol.2019190794. Epub 2019 Dec 3. |
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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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| 12 months |
| concordance rate of clinical stagings and true M staging obtained by biopsy or follow-up | 18 months |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |