AzTrials
AzTrials

Pancreas Cancer, Duct Cell AdenocarcinomaDWI-PDACNCT05340569

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

A study testing Whole-body diffusion-weighted magnetic resonance imaging in people with Pancreas Cancer, Duct Cell Adenocarcinoma and Pancreas Adenocarcinoma, run by Laval University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Whole-body diffusion-weighted magnetic resonance imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
28 Mar 2022to 30 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • CHU de Québec

    Québec, Quebec, G1R 2J6

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Whole-body diffusion-weighted magnetic resonance imaging
Keywords
DWI, PDAC, Carcinomatosis, Diagnostic laparoscopy
Medical subject headings
Pancreatic Neoplasms, Peritoneal Neoplasms, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole-body diffusion-weighted magnetic resonance imagingDiagnostic test

    See arm description.

Study groups in NCT05340569
Study groupRoleWhat they receive
DWI-MRIExperimentalPatients to undergo DWI-MRI (patients include in the study.
Receives: Diagnostic Test: Whole-body diffusion-weighted magnetic resonance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peritoneal findings

    The number of cases in which peritoneal findings on MRI altered clinical management.

    Measured: 24 months

  2. Unexpected abortion

    The rate of unexpected aborted surgery due to peritoneal metastases discovery at surgery.

    Measured: 24 months

Secondary outcomes (1)

  1. Early distant recurrence

    The number of cases with early distant recurrence (less than 6 months).

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2022
  2. Study start28 Mar 2022
  3. Primary completion30 Mar 2024
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05340569
Sponsor's protocol ID
2022-6186
Acronym
DWI-PDAC
Status last verified
Mar 2025
First submitted
11 Apr 2022
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • De La Cruz MS, Young AP, Ruffin MT. Diagnosis and management of pancreatic cancer. Am Fam Physician. 2014 Apr 15;89(8):626-32.

    PubMed 24784121

  • Hishinuma S, Ogata Y, Tomikawa M, Ozawa I, Hirabayashi K, Igarashi S. Patterns of recurrence after curative resection of pancreatic cancer, based on autopsy findings. J Gastrointest Surg. 2006 Apr;10(4):511-8. doi: 10.1016/j.gassur.2005.09.016.

    PubMed 16627216

  • Ryan DP, Hong TS, Bardeesy N. Pancreatic adenocarcinoma. N Engl J Med. 2014 Sep 11;371(11):1039-49. doi: 10.1056/NEJMra1404198. No abstract available.

    PubMed 25207767

  • Mizrahi JD, Surana R, Valle JW, Shroff RT. Pancreatic cancer. Lancet. 2020 Jun 27;395(10242):2008-2020. doi: 10.1016/S0140-6736(20)30974-0.

    PubMed 32593337

  • Patel CM, Sahdev A, Reznek RH. CT, MRI and PET imaging in peritoneal malignancy. Cancer Imaging. 2011 Aug 24;11(1):123-39. doi: 10.1102/1470-7330.2011.0016.

    PubMed 21865109

  • Allen VB, Gurusamy KS, Takwoingi Y, Kalia A, Davidson BR. Diagnostic accuracy of laparoscopy following computed tomography (CT) scanning for assessing the resectability with curative intent in pancreatic and periampullary cancer. Cochrane Database Syst Rev. 2016 Jul 6;7(7):CD009323. doi: 10.1002/14651858.CD009323.pub3.

    PubMed 27383694

  • Brind'Amour A, Webb M, Parapini M, Sideris L, Segedi M, Chung SW, Chartier-Plante S, Dube P, Scudamore CH, Kim PTW. The role of intraperitoneal chemotherapy in the surgical management of pancreatic ductal adenocarcinoma: a systematic review. Clin Exp Metastasis. 2021 Apr;38(2):187-196. doi: 10.1007/s10585-021-10074-2. Epub 2021 Jan 24.

    PubMed 33486670

  • Paracha M, Van Orden K, Patts G, Tseng J, McAneny D, Sachs T. Opportunity Lost? Diagnostic Laparoscopy in Patients with Pancreatic Cancer in the National Surgical Quality Improvement Program Database. World J Surg. 2019 Mar;43(3):937-943. doi: 10.1007/s00268-018-4855-8.

    PubMed 30478680

  • Jayakrishnan TT, Zacharias AJ, Sharma A, Pappas SG, Gamblin TC, Turaga KK. Role of laparoscopy in patients with peritoneal metastases considered for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). World J Surg Oncol. 2014 Aug 21;12:270. doi: 10.1186/1477-7819-12-270.

    PubMed 25145962

  • Vasilyeva E, Li J, Desai S, Chung SW, Scudamore CH, Segedi M, Kim PT. Impact of surgical wait times on oncologic outcomes in resectable pancreas adenocarcinoma. HPB (Oxford). 2020 Jun;22(6):892-899. doi: 10.1016/j.hpb.2019.10.013. Epub 2019 Nov 13.

    PubMed 31732464

  • Mattevi C, Garnier J, Marchese U, Ewald J, Gilabert M, Poizat F, Piana G, Delpero JR, Turrini O. Has the non-resection rate decreased during the last two decades among patients undergoing surgical exploration for pancreatic adenocarcinoma? BMC Surg. 2020 Aug 5;20(1):176. doi: 10.1186/s12893-020-00835-3.

    PubMed 32758203

  • Liu X, Fu Y, Chen Q, Wu J, Gao W, Jiang K, Miao Y, Wei J. Predictors of distant metastasis on exploration in patients with potentially resectable pancreatic cancer. BMC Gastroenterol. 2018 Nov 6;18(1):168. doi: 10.1186/s12876-018-0891-y.

    PubMed 30400836

  • De Rosa A, Cameron IC, Gomez D. Indications for staging laparoscopy in pancreatic cancer. HPB (Oxford). 2016 Jan;18(1):13-20. doi: 10.1016/j.hpb.2015.10.004. Epub 2015 Nov 18.

    PubMed 26776846

  • Dong L, Li K, Peng T. Diagnostic value of diffusion-weighted imaging/magnetic resonance imaging for peritoneal metastasis from malignant tumor: A systematic review and meta-analysis. Medicine (Baltimore). 2021 Feb 5;100(5):e24251. doi: 10.1097/MD.0000000000024251.

    PubMed 33592867

Questions about this trial

What is this clinical trial studying?

A study testing Whole-body diffusion-weighted magnetic resonance imaging in people with Pancreas Cancer, Duct Cell Adenocarcinoma and Pancreas Adenocarcinoma, run by Laval University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peritoneal findings (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05340569, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in