Clinical trial NCT03202199: Neoadjuvant Chemotherapy Response Assessment by Combined PET-MRI in Borderline and Locally Advanced Pancreatic Adenocarcinoma.
Official title: Neoadjuvant Chemotherapy Response Assessment by Combined PET-MRI in Borderline and Locally Advanced Pancreatic Adenocarcinoma. PACMI (Pancreatic AdenoCarcinoma Multimodality Imaging)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Adenocarcinoma
Keywords: Adenocarcinoma, pancreas, PET/MRI
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18yo
* Locally advanced or borderline resectable pancreatic adenocarcinoma, according to the NCCN classification
* Eligible for neoadjuvant chemotherapy ± radiation therapy, according to the local tumor board
* With contraception if fertile woman
* With informed consent obtained
* Affiliated to French health care system

Exclusion Criteria:

* Previous treatment for the pancreatic adenocarcinoma
* Metastases
* Contra-indication to MRI acquisition (pace maker, metallic device, ..)
* Contra-indication to PET acquisition (non controlled diabetes with glycaemia \> 11 mmol/L)
* Pregnancy or breast feeding
* Patient unable to give his consent

Primary outcomes:
measure: Accuracy of PET/MRI to predict pancreatic adenocarcinoma rescetability after neaadjuvant treatment
timeFrame: PET/MRI performed less than one month before the surgery
Secondary outcomes:
measure: Accuracy of tumor size, ADC, D, D*, F and SUVmax at baseline, before surgery and their variations for resectability
timeFrame: PET MRI performed at baseline (15 days before the treatment beginning) less than one month before the surgery
measure: Accuracy of tumor size, ADC, D, D*, F and SUVmax at baseline, before surgery and their variations for response evaluation
timeFrame: PET MRI performed at baseline (15 days before the treatment beginning) less than one month before the surgery
measure: Comparison of the accuracies of PT MRI and CT for resectability assessment
timeFrame: CT and PET MRI performed less than one month before the surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié Salpetriere Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Mathilde WAGNER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: