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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Device: PET/MRI Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: PET/MRI
PET/MRI examination
Device: PET/MRI
2 PET/MRI examinations




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Mathilde WAGNER, MD, PhD 0033142178305 mathilde.wagner@aphp.fr
Contact: Olivier LUCIDARME, MD, PhD 0033142176322 olivier.lucidarme@aphp.fr

Locations
France
Pitié Salpetriere Hospital Recruiting
Paris, France
Contact: Mathilde WAGNER, MD, PhD    0033142178305    mathilde.wagner@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Mathilde WAGNER, MD, PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03202199     History of Changes
Other Study ID Numbers: P150930
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Adenocarcinoma, pancreas, PET/MRI

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms