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The aim of this study was to assess the diagnostic accuracy of PET-MRI to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.
Background: Pancreatic cancer is the 8th more common cancer in the world. At diagnosis, majority of patients present with unresectable locally advanced disease. Standard of care therapy for locally advanced pancreatic cancer includes chemotherapy ± radiation therapy. It is published that computed tomography underestimate the effectiveness of neoajuvant treatment and there is a lack of criteria allowing identifying the responders. The misinterpretation of scans may be linked to the large desmoplatic reaction, present in pancreatic cancer, which would not be expected to regress. PET-MR is an imaging technique that associates PET and MR imaging, performed during the same examination. The main hypothesis is that PET-MR imaging could accurately identify resectable and no resectable pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.
Primary aim Assess the diagnostic accuracy of PET-MRI to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy
Secondary aims Assess the accuracy of quantitative PET-MRI parameters to predict resectability and response of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy Compare accuracy of PET-MRI and CT to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.
Assess inter and intra observer reproducibility of PET-MRI reading CT to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.
Number of subjects 125 Number of centers 8
Design 2 PET-MRI examination will be performed, one before the beginning of the neoadjuvant/induction treatment, and the second one after the neoadjuvant/induction treatment and less than 30 days before the surgery. The PET-MRI examinations will include whole body and organ specific imaging.
The whole body workflow will include
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET/MRI | Experimental | PET/MRI examination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/MRI | Device | 2 PET/MRI examinations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of PET/MRI to predict pancreatic adenocarcinoma rescetability after neaadjuvant treatment | PET/MRI performed less than one month before the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of tumor size, ADC, D, D*, F and SUVmax at baseline, before surgery and their variations for resectability | PET MRI performed at baseline (15 days before the treatment beginning) less than one month before the surgery | |
| Accuracy of tumor size, ADC, D, D*, F and SUVmax at baseline, before surgery and their variations for response evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mathilde WAGNER, MD, PhD | Contact | 0033142178305 | mathilde.wagner@aphp.fr | |
| Olivier LUCIDARME, MD, PhD | Contact | 0033142176322 | olivier.lucidarme@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Mathilde WAGNER, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pitié Salpetriere Hospital | Recruiting | Paris | France |
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| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| PET MRI performed at baseline (15 days before the treatment beginning) less than one month before the surgery |
| Comparison of the accuracies of PT MRI and CT for resectability assessment | CT and PET MRI performed less than one month before the surgery |