Neoadjuvant Chemotherapy Response Assessment by Combined PET-MRI in Borderline and Locally Advanced Pancreatic Adenocarcinoma.
PACMI
1 other identifier
interventional
125
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 2017
CompletedFirst Submitted
Initial submission to the registry
June 27, 2017
CompletedFirst Posted
Study publicly available on registry
June 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedJuly 26, 2017
June 1, 2017
2.5 years
June 27, 2017
July 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy of PET/MRI to predict pancreatic adenocarcinoma rescetability after neaadjuvant treatment
PET/MRI performed less than one month before the surgery
Secondary Outcomes (3)
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
Study Arms (1)
PET/MRI
EXPERIMENTALPET/MRI examination
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pitié Salpetriere Hospital
Paris, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mathilde WAGNER, MD, PhD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2017
First Posted
June 28, 2017
Study Start
June 19, 2017
Primary Completion
January 1, 2020
Study Completion
July 1, 2021
Last Updated
July 26, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share