Back to resultsDiffusion MRI for Pancreatic Adenocarcinoma (PANDA)
Primary Purpose
Pancreatic Adenocarcinoma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diffusion-weighted nuclear magnetic resonance imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- age > 18 year old,
- no general contraindication for pancreatic surgery,
- pancreatic mass suspected or demonstrated to be a pancreatic adenocarcinoma,
- CAP CT of excellent technical quality showing a pancreatic tumor deemed resectable or border line (portal and/or superior mesenteric venous circumferential involvement < 180°
- Resectability confirmed by a medical/surgical multidisciplinary review,
- if neoadjuvant therapy was applied, patients were included in the study: only the second evaluation will be considered.
- informed consent prepared and signed.
Exclusion Criteria:
- locally advanced pancreatic adenocarcinoma (involvement > 180°in circumference of superior mesenteric venous (SMV) or portal vein, superficial vein thrombosis, superior mesenteric artery (SMA) involvement < 180°)
- unresectable tumour (circumferential involvement > 180 ° of the SMA, involvement of the celiac artery, thrombosis of the portal vein or vena cava, or complete VMS thrombosis
- metastasis of any organ visible on thoraco-abdominopelvic CT scan
- time lag exceeding 21 days between diffusion-weighted MRI and surgery
- contraindication for an MRI
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
diffusion-weighted nuclear magnetic resonance imaging
Arm Description
detection of liver metastasis on diffusion-weighted nuclear magnetic resonance imaging in patients with potentially resectable pancreatic adenocarcinoma
Outcomes
Primary Outcome Measures
The rate of detection of liver metastasis on diffusion-weighted MRI in patients with potentially resectable pancreatic adenocarcinoma.
The primary outcome will be measured at the time of diagnosis of liver metastasis, either based on histological study (within one month after surgery or biopsy) or based on follow-up (maximum time frame of 24 months after inclusion).
Secondary Outcome Measures
Diagnostic performance of diffusion-weighted MRI for the preoperative diagnosis of liver metastasis in patients with potentially resectable adenocarcinoma
Sensitivity, specificity, predictive positive value, negative predictive value and accuracy of diffusion-weighted MRI for the preoperative diagnosis of liver metastasis in patients with potentially resectable adenocarcinoma. The reference standard for the positive diagnosis of liver metastasis will be based on the pathological report of preoperative or intraoperative biopsies. In case of absence of tissue sample, the definitive diagnosis will be based on the 2-year follow-up.
Rate of patients for whom the therapeutic strategy is modified as a consequence of the diagnosis of liver metastasis on diffusion-weighted MRI
Modification of therapeutic strategy is defined by abandonment of surgical exploration and/or of pancreatic excision after surgical exploration
Full Information
NCT ID
NCT02896946
First Posted
September 7, 2016
Last Updated
May 23, 2019
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02896946
Brief Title
Diffusion MRI for Pancreatic Adenocarcinoma
Acronym
PANDA
Official Title
Use of Diffusion-weighted MRI for the Detection of Liver Metastases in Potentially Resectable Pancreatic Adenocarcinomas: a Prospective Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The detection of small liver metastases represents a major challenge during the staging process of patients with pancreatic adenocarcinoma. Currently, thoraco-abdominopelvic CT represents the established imaging modality for selecting patients with pancreatic adenocarcinoma for curative surgery. However, despite its performance, 13% to 23% of patients undergoing a surgical procedure are finally found to have an unresectable disease because of arterial involvement, peritoneal carcinomatosis, or the existence liver metastasis that had not been detected by preoperative workup. Compared to CT, diffusion-weighted MRI provides a better contrast resolution for soft tissue and liver imaging, and thus leads to a better detection of focal liver lesions. Hence, it could be hypothesized that the use of DW-MRI in patients with potentially resectable PA may improve the selection process of candidates for curative pancreatic resection by increasing the detection of LM undiagnosed by traditional preoperative work-up
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
diffusion-weighted nuclear magnetic resonance imaging
Arm Type
Experimental
Arm Description
detection of liver metastasis on diffusion-weighted nuclear magnetic resonance imaging in patients with potentially resectable pancreatic adenocarcinoma
Intervention Type
Radiation
Intervention Name(s)
Diffusion-weighted nuclear magnetic resonance imaging
Intervention Description
All MRI examinations will be carried out using a Siemens Magnetom Avanto syngo MR B15 1.5 Tesla (Erlangen, Germany) or a Philips Intera 1.5 Tesla (Eindhoven, The Netherlands) and will include the following sequences: (i) T2 fat sat, with a FOV of 350 x 262, and a matrix of 384 x 207; slices, 30 per sequence, 6 mm thick; (ii) T1 in-phase and out-of-phase with a FOV of 380 x 262, and a matrix of 256 x 158; slices, 30 per sequence, 6 mm thick; (iii) T1 water excitation (= T1 ProSat), with a FOV of 300 x 300, and a matrix of 320 x 220; obtaining 20 slices of 4 mm; (iv) VIBE and THRIVE (dynamic T1 axial 3D EG after injection, during the arterial, portal venous, and late phases, in an axial plane, and optionally in a coronal plane during the portal venous phase), with a FOV of 400 x 312, a matrix of 384 x 192, and with fat suppression and breath-hold; slices 3 mm thick, with liver and pancreatic coverage. Contrast agent: gadobenate dimeglumine (MultiHance, Bracco Imaging, France).
Primary Outcome Measure Information:
Title
The rate of detection of liver metastasis on diffusion-weighted MRI in patients with potentially resectable pancreatic adenocarcinoma.
Description
The primary outcome will be measured at the time of diagnosis of liver metastasis, either based on histological study (within one month after surgery or biopsy) or based on follow-up (maximum time frame of 24 months after inclusion).
Time Frame
At the time of diagnosis of liver metastasis on histological study or based on follow-up (maximum time frame of 24 months after inclusion).
Secondary Outcome Measure Information:
Title
Diagnostic performance of diffusion-weighted MRI for the preoperative diagnosis of liver metastasis in patients with potentially resectable adenocarcinoma
Description
Sensitivity, specificity, predictive positive value, negative predictive value and accuracy of diffusion-weighted MRI for the preoperative diagnosis of liver metastasis in patients with potentially resectable adenocarcinoma. The reference standard for the positive diagnosis of liver metastasis will be based on the pathological report of preoperative or intraoperative biopsies. In case of absence of tissue sample, the definitive diagnosis will be based on the 2-year follow-up.
Time Frame
At the time of diagnosis of liver metastasis on histological study or based on follow-up (maximum time frame of 24 months after inclusion).
Title
Rate of patients for whom the therapeutic strategy is modified as a consequence of the diagnosis of liver metastasis on diffusion-weighted MRI
Description
Modification of therapeutic strategy is defined by abandonment of surgical exploration and/or of pancreatic excision after surgical exploration
Time Frame
At the time of diagnosis of liver metastasis on histological study or based on follow-up (maximum time frame of 24 months after inclusion).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 18 year old,
no general contraindication for pancreatic surgery,
pancreatic mass suspected or demonstrated to be a pancreatic adenocarcinoma,
CAP CT of excellent technical quality showing a pancreatic tumor deemed resectable or border line (portal and/or superior mesenteric venous circumferential involvement < 180°
Resectability confirmed by a medical/surgical multidisciplinary review,
if neoadjuvant therapy was applied, patients were included in the study: only the second evaluation will be considered.
informed consent prepared and signed.
Exclusion Criteria:
locally advanced pancreatic adenocarcinoma (involvement > 180°in circumference of superior mesenteric venous (SMV) or portal vein, superficial vein thrombosis, superior mesenteric artery (SMA) involvement < 180°)
unresectable tumour (circumferential involvement > 180 ° of the SMA, involvement of the celiac artery, thrombosis of the portal vein or vena cava, or complete VMS thrombosis
metastasis of any organ visible on thoraco-abdominopelvic CT scan
time lag exceeding 21 days between diffusion-weighted MRI and surgery
contraindication for an MRI
12. IPD Sharing Statement
Citations:
PubMed Identifier
30240298
Citation
Marion-Audibert AM, Vullierme MP, Ronot M, Mabrut JY, Sauvanet A, Zins M, Cuilleron M, Sa-Cunha A, Levy P, Rode A. Routine MRI With DWI Sequences to Detect Liver Metastases in Patients With Potentially Resectable Pancreatic Ductal Carcinoma and Normal Liver CT: A Prospective Multicenter Study. AJR Am J Roentgenol. 2018 Nov;211(5):W217-W225. doi: 10.2214/AJR.18.19640. Epub 2018 Sep 21.
Results Reference
result
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Diffusion MRI for Pancreatic Adenocarcinoma
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