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

Neoadjuvant Chemotherapy Response Assessment by Combined PET-MRI in Borderline and Locally Advanced Pancreatic Adenocarcinoma. PACMI (Pancreatic AdenoCarcinoma Multimodality Imaging)

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Adenocarcinoma
• Intervention / Treatment: Device: PET/MRI

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.

• Study Type: Interventional
• Enrollment (Anticipated): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Recruiting
    • Pitié Salpétrière Hospital
    • Contact: Mathilde WAGNER, MD, PhD; Phone Number: 0033142178305; Email: mathilde.wagner@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PET/MRI; PET/MRI examination	Device: PET/MRI; 2 PET/MRI examinations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Mathilde WAGNER, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): July 26, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Adenocarcinoma, pancreas, PET/MRI
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: P150930

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No