Neoadjuvant Chemotherapy Response Assessment by Combined PET-MRI in Borderline and Locally Advanced Pancreatic Adenocarcinoma.

Overview

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.

Full Title of Study: “Neoadjuvant Chemotherapy Response Assessment by Combined PET-MRI in Borderline and Locally Advanced Pancreatic Adenocarcinoma. PACMI (Pancreatic AdenoCarcinoma Multimodality Imaging)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 1, 2020

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.

Interventions

  • Device: PET/MRI
    • 2 PET/MRI examinations

Arms, Groups and Cohorts

  • Experimental: PET/MRI
    • PET/MRI examination

Clinical Trial Outcome Measures

Primary Measures

  • Accuracy of PET/MRI to predict pancreatic adenocarcinoma rescetability after neaadjuvant treatment
    • Time Frame: PET/MRI performed less than one month before the surgery

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mathilde WAGNER, MD, PhD, Principal Investigator, Assistance Publique – Hôpitaux de Paris
  • Overall Contact(s)
    • Mathilde WAGNER, MD, PhD, 0033142178305, mathilde.wagner@aphp.fr

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