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This pilot clinical trial studies gene expression analysis and fludeoxyglucose F 18 (FDG) positron emission tomography (PET)/magnetic resonance imaging (MRI) in evaluating treatment response in patients with rectal cancer that has spread to nearby tissue or lymph nodes undergoing chemotherapy and radiation therapy before surgery. Studying samples of tissue in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and may also help doctors predict a patient's response to treatment before surgery. PET-MRI is a procedure that combines the pictures from a PET scan and an MRI scan. The combined scans give more detailed pictures of areas inside the body than either scan gives by itself. PET-MRI may help determine how well people respond to pre-surgery chemotherapy and radiation therapy and help the surgeon make the best plan for removal of the tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (FDG PET/MRI, gene expression) | Experimental | FDG PET/MRI at baseline and at 2-4 weeks before surgery (after neoadjuvant chemoradiation). Tissue samples for gene expression at baseline and during surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fludeoxyglucose F 18 | Radiation | Undergo FDG PET/MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in FDG-PET/MR SUVmax | Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response. | Baseline to up to 2 weeks before surgery |
| Change in FDG-PET/MR SUVmean | Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response. | Baseline to up to 2 weeks before surgery |
| Change in ADCmean | Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response. | Baseline to up to 2 weeks before surgery |
| Radiosensitivity index | Index is calculated based on tumor gene expression. Will be correlated with the descriptive changes in FDG-PET/MR SUV and ADC parameters. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Parag Parikh, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| positron emission tomography | Device | Undergo FDG PET/MRI |
|
|
| magnetic resonance imaging | Device | Undergo FDG PET/MRI |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| D049268 | Positron-Emission Tomography |
| D014054 | Tomography |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D003947 | Diagnostic Techniques, Radioisotope |
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