Diffusion MRI for Pancreatic Adenocarcinoma

NCT ID: NCT02896946

Last Updated: 2019-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28

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

Conditions

Pancreatic Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

diffusion-weighted nuclear magnetic resonance imaging

detection of liver metastasis on diffusion-weighted nuclear magnetic resonance imaging in patients with potentially resectable pancreatic adenocarcinoma

Group Type: EXPERIMENTAL

Diffusion-weighted nuclear magnetic resonance imaging

Intervention Type: RADIATION

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).

Interventions

Diffusion-weighted nuclear magnetic resonance imaging

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).

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: RESULT

PMID: 30240298 (View on PubMed)

Other Identifiers

2010.631

Identifier Type: -

Identifier Source: org_study_id