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2017-06-19
2020-01-01
2021-07-01
125
NCT03202199
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
INTERVENTIONAL
Neoadjuvant Chemotherapy Response Assessment by Combined PET-MRI in Borderline and Locally Advanced Pancreatic Adenocarcinoma.
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 * [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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-06-27 | N/A | 2017-07-24 |
2017-06-27 | N/A | 2017-07-26 |
2017-06-28 | N/A | 2017-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: PET/MRI PET/MRI examination | DEVICE: PET/MRI
|
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Mathilde WAGNER, MD, PhD Phone Number: 0033142178305 Email: mathilde.wagner@aphp.fr |
Study Contact Backup Name: Olivier LUCIDARME, MD, PhD Phone Number: 0033142176322 Email: olivier.lucidarme@aphp.fr |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
