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| Name | Class |
|---|---|
| Associazione Italiana per la Ricerca sul Cancro | OTHER |
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Evaluate the potential role of PET/MRI as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (nCRT).
This is a prospective, observational single center study which plans to enroll patients with biopsy proven potentially resectable esophageal or junctional cancer scheduled to receive nCRT (CROSS regimen) prior to surgery.
The study aims to evaluate Routine pre-treatment work-up includes PET to stage the tumour extension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid PET/MRI | Other | For the purposes of the study, in addition to standard imaging (EUS and CT scan), a fully integrated hybrid PET/MRI (PET/MRI) study with FDG will replace the Standard PET (pre-surgical evaluation) used for evaluating distant metastases and will be considered as the add-on procedure at three time points. The additional evaluation for patients is that during nCRT treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hybrid PET/MRI | Other | An additional intermediate 18-FDG PET/MRI will be performed during neoadjuvant chemo-radiation therapy. Routine pre-treatment work-up PET/MRI will replace PET alone. |
| Measure | Description | Time Frame |
|---|---|---|
| Response to neoadjuvant treatment -MRI | MRI component including Dynamic Contrast Enhanced (DCE); quantitative evaluation and delta between timepoints | 0-36 months |
| Response to neoadjuvant treatment -PET | PET component -quantitative evaluation and delta between timepoints | 0-36 months |
| Response to neoadjuvant treatment - Histology | Evaluate degree of tumor regression after neoadjuvant therapy according to the Mandard Tumour regression grade ; integrated Immunohistochemistry | 0-36 months |
| Response to neoadjuvant treatment -Radiomics | Radiomic features extracted from hybrid imaging | 0-36 months |
| Imaging parameters as potential predictors of tumor response | Select imaging parameters that can be considered potential predictors of the responder/non-responder status assessment | 0- 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Early regression model (ERI) | Evaluate the ERI model as a predictor of histological response (TRG grade) based on MRI tumor volume assessment | 0- 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco De Cobelli, MD | IRCCS Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deaprtment of Radiology, IRCCS Ospedale San Raffaele | Milan | 20132 | Italy |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |