Neoadjuvant Chemotherapy Response Assessment by Combined PET-MRI in Borderline and Locally Advanced Pancreatic Adenocarcinoma. (PACMI)
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|ClinicalTrials.gov Identifier: NCT03202199|
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : July 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma||Device: PET/MRI||Not Applicable|
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
- [18F]-2-fluoro-2-deoxy-D-glucose PET acquisition
- T1-mDIXON imaging (for attenuation correction calculation)
- diffusion-weighted imaging
- T1-DIXON imaging post gadolinium chelate injection. The organ specific workflow will be focused on the abdominal area, including the liver and the pancreas, and will include
- [18F]-2-fluoro-2-deoxy-D-glucose PET acquisition,
- T2-weighted imaging with and without fat saturation,
- T1-DIXON imaging before and after dynamic injection of gadolinium chelate,
- diffusion-weighted imaging,
- IVIM-diffusion weighted imaging acquisition covering the pancreatic lesion. Qualitative analysis of PET-MRI using a Likert score will be compared to pathological results in order to obtain the accuracy of PET-MRI for resectability assessement.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Chemotherapy Response Assessment by Combined PET-MRI in Borderline and Locally Advanced Pancreatic Adenocarcinoma. PACMI (Pancreatic AdenoCarcinoma Multimodality Imaging)|
|Actual Study Start Date :||June 19, 2017|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||July 1, 2021|
2 PET/MRI examinations
- Accuracy of PET/MRI to predict pancreatic adenocarcinoma rescetability after neaadjuvant treatment [ Time Frame: PET/MRI performed 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 resectability [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: CT and PET MRI performed less than one month before the surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202199
|Contact: Mathilde WAGNER, MD, PhDfirstname.lastname@example.org|
|Contact: Olivier LUCIDARME, MD, PhDemail@example.com|
|Pitié Salpetriere Hospital||Recruiting|
|Contact: Mathilde WAGNER, MD, PhD 0033142178305 firstname.lastname@example.org|
|Principal Investigator:||Mathilde WAGNER, MD, PhD||Assistance Publique - Hôpitaux de Paris|