Evaluation of the FOCUS Diffusion's Added Clinical Value Compared to Conventional MRI

NCT03961646 | Completed

• 1 other identifier: Diffusion Focus
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The radiologist plays a key role in the management of pancreatic tumours, which are potentially serious. While the scanner, with its high spatial resolution, plays a major role in pancreatic pathology, and in particular in the assessment of operability, MRI, with its good contrast resolution, has proven its contribution to the detection and characterization of focal lesions. Each MRI examination consists of several series of images called sequences, each with its own particularity, to highlight different types of abnormalities such as edema, bleeding, tumor content or vascularization. All the sequences performed constitute a "protocol". The diffusion sequence is a technology that allows the microscopic random movements of water molecules to be translated into images. It thus makes it possible to differentiate between certain aggressive tumours which are characterised by a higher cell density than healthy tissue, in which water molecules do not circulate freely, benign lesions such as cysts in which the circulation of water molecules is not hindered. The calculation of the Apparent Diffusion Coefficient (ADC), an estimate of the diffusion rate of water molecules, is a quantitative diagnostic tool validated in many fields of application and in particular in oncology.

Conditions

Cancer of Pancreas

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  Diagnostic accuracy difference between the standard protocol and the combined protocol.

  Time of inclusion

Secondary Outcomes (4)

• Diagnostic performances of benignity or malignancy

  Time of inclusion

• Diagnostic confidence of radiologist's benign or malignant condition

  Time of inclusion

• Lesions' detected number

  Time of inclusion

• Image quality

  Time of inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with benign or malignant pancreatic lesions.

You may qualify if:

• Male or female whose age ≥ 18 years old (Adult patient)
• Francophone patient
• Pancreatic MRI performed at the GHPSJ on 3 Tesla MRI between September 2014 (date of introduction of the FOCUS diffusion sequence) and April 2018
• Presence of at least one proven benign or malignant focal pancreatic lesion visible on at least one of the MRI sequences

You may not qualify if:

• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient objecting to the use of their data for this research
• Papillary and mucinous intra-channel tumour of pancreas (TIPMP) of secondary channels measuring less than 30mm.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related Publications (17)

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  PMID: 23533288 BACKGROUND

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  PMID: 21693662 BACKGROUND

• Kim HW, Lee JC, Paik KH, Kang J, Kim YH, Yoon YS, Han HS, Kim J, Hwang JH. Adjunctive role of preoperative liver magnetic resonance imaging for potentially resectable pancreatic cancer. Surgery. 2017 Jun;161(6):1579-1587. doi: 10.1016/j.surg.2016.12.038. Epub 2017 Feb 23.

  PMID: 28237643 BACKGROUND

• Zins M, Matos C, Cassinotto C. Pancreatic Adenocarcinoma Staging in the Era of Preoperative Chemotherapy and Radiation Therapy. Radiology. 2018 May;287(2):374-390. doi: 10.1148/radiol.2018171670.

  PMID: 29668413 BACKGROUND

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  PMID: 21139505 BACKGROUND

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  PMID: 22262868 BACKGROUND

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  PMID: 21129638 BACKGROUND

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• Andre JB, Zaharchuk G, Saritas E, Komakula S, Shankaranarayan A, Banerjee S, Rosenberg J, Nishimura DG, Fischbein NJ. Clinical evaluation of reduced field-of-view diffusion-weighted imaging of the cervical and thoracic spine and spinal cord. AJNR Am J Neuroradiol. 2012 Nov;33(10):1860-6. doi: 10.3174/ajnr.A3134. Epub 2012 May 3.

  PMID: 22555576 BACKGROUND

• Reischauer C, Wilm BJ, Froehlich JM, Gutzeit A, Prikler L, Gablinger R, Boesiger P, Wentz KU. High-resolution diffusion tensor imaging of prostate cancer using a reduced FOV technique. Eur J Radiol. 2011 Nov;80(2):e34-41. doi: 10.1016/j.ejrad.2010.06.038. Epub 2010 Jul 16.

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• Ma C, Li YJ, Pan CS, Wang H, Wang J, Chen SY, Lu JP. High resolution diffusion weighted magnetic resonance imaging of the pancreas using reduced field of view single-shot echo-planar imaging at 3 T. Magn Reson Imaging. 2014 Feb;32(2):125-31. doi: 10.1016/j.mri.2013.10.005. Epub 2013 Oct 18.

  PMID: 24231348 BACKGROUND

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• Kim H, Lee JM, Yoon JH, Jang JY, Kim SW, Ryu JK, Kannengiesser S, Han JK, Choi BI. Reduced Field-of-View Diffusion-Weighted Magnetic Resonance Imaging of the Pancreas: Comparison with Conventional Single-Shot Echo-Planar Imaging. Korean J Radiol. 2015 Nov-Dec;16(6):1216-25. doi: 10.3348/kjr.2015.16.6.1216. Epub 2015 Oct 26.

  PMID: 26576110 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Marc ZINS, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 23, 2019
• Study Start: February 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

FR (1)