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

Pancreatic Adenocarcinoma Clinical Trial

— PACMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03202199
• Other study ID #: P150930
• Status: Recruiting
• Phase: N/A
• First received: June 27, 2017
• Last updated: July 24, 2017
• Start date: June 19, 2017
• Est. completion date: July 1, 2021

Study information

• Verified date: June 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Mathilde WAGNER, MD, PhD
• Phone: 0033142178305
• Email: mathilde.wagner[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: July 1, 2021
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

Intervention

Device:
• PET/MRI
2 PET/MRI examinations

Locations

Country	Name	City	State
France	Pitié Salpetriere Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of PET/MRI to predict pancreatic adenocarcinoma rescetability after neaadjuvant treatment		PET/MRI performed less than one month before the surgery
Secondary	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
Secondary	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
Secondary	Comparison of the accuracies of PT MRI and CT for resectability assessment		CT and PET MRI performed less than one month before the surgery