DWI-PDAC: Diagnostic Value of DWI-MRI for Detection of Peritoneal Metastases in High-risk Pancreatic Ductal Adenocarcinoma.

Sponsor

Laval University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05340569

Collaborator

(none)

Enrollment

Location

Arm

29.2

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Diffusion-weighted magnetic resonance imaging (DWI/MRI) has been described in recent literature as a highly sensitive and specific modality for the detection of peritoneal metastases (PM). It has been demonstrated to be superior to computed tomography (CT) for patients with known peritoneal disease from colorectal and gynaecological malignancies. However, the literature is scarce on the role of DWI/MRI in patients with pancreatic ductal-adenocarcinoma (PDAC). The aim of this study is to prospectively assess the added value of whole-body DWI/MRI (WB-DWI/MRI) to CT for detection of PM in the preoperative staging of patients with high-risk PDAC and evaluate how it correlates with intraoperative findings.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cancer, Duct Cell Adenocarcinoma Pancreas Adenocarcinoma Peritoneal Metastases Peritoneal Carcinomatosis	Diagnostic Test: Whole-body diffusion-weighted magnetic resonance imaging	N/A

Detailed Description

This is a prospective study from a single center. Patients will be evaluated and operated on by one of five surgeons with a subspeciality in hepato-biliary and pancreatic surgery. After thorough assessment for resectability, patients with PDAC considered resectable based on CT, but at high-risk for peritoneal disease, will be prospectively included in the study and assessed with WB-DWI/MRI within 4 weeks of the planned surgery, with the standard protocol including the following sequences: Patients will drink 1L of pineapple juice one hour prior to the examination in order to provide a negative intraluminal contrast. Patients will receive 20 mg of intravenous hyoscine butylbromide at the beginning of the MR exam in order to reduce bowel peristalsis. Sequences will include Axial et Coronal T2WI of the abdomen and pelvis, axial DWI with b values of 0, 50 and 1000 of the abdomen and pelvis, as well as Pre and post gadolinium-based contrast Axial and Coronal 3D T1WGRE. Patients with no evidence of PM on WB-DWI/MRI will be operated on and undergo pancreatic resection following the usual exploration of the peritoneal cavity in case of occult metastatic disease. Patients with suspicion of PM on WB-DWI/MRI will be approached with a diagnostic laparoscopy first, then undergo pancreatic resection if no evidence of PM is found. Each case will be followed for at least 6 months.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Diagnostic Value of Diffusion-weighted Magnetic Resonance Imaging for Detection of Peritoneal Metastases in High-risk Pancreatic Ductal Adenocarcinoma: a Pilot Study.

Actual Study Start Date :

Mar 28, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DWI-MRI Patients to undergo DWI-MRI (patients include in the study.	Diagnostic Test: Whole-body diffusion-weighted magnetic resonance imaging See arm description.

Arm

Intervention/Treatment

Experimental: DWI-MRI

Patients to undergo DWI-MRI (patients include in the study.

Diagnostic Test: Whole-body diffusion-weighted magnetic resonance imaging

See arm description.

Outcome Measures

Primary Outcome Measures

Peritoneal findings [24 months]
The number of cases in which peritoneal findings on MRI altered clinical management.
Unexpected abortion [24 months]
The rate of unexpected aborted surgery due to peritoneal metastases discovery at surgery.

Secondary Outcome Measures

Early distant recurrence [30 months]
The number of cases with early distant recurrence (less than 6 months).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Confirmed diagnosis of pancreatic ductal adenocarcinoma.
Resectable disease or borderline resectable disease based on CT.
Tumor size ≥ 3 cm.
CA 19-9 ≥ 400 U/mL with normal bilirubin level (< 40)
No evidence of distant metastases.
Patient fit for pancreatic resection (ECOG 0 or 1).

Exclusion Criteria:

Impossibility to obtain tissue diagnosis preoperatively confirming pancreatic ductal adenocarcinoma.
Locally advanced disease on CT.
Tumor size < 3 cm.
CA 19-9 < 400 U/mL or CA 19-9 ≥ 400 U/mL with no preoperative drainage.
Suspicion of distant metastases, including peritoneal metastases, on CT.
Patient who is unable to have MRI.
Patient unfit for pancreatic resection (ECOG 2 or more).