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

April 26, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

Evaluation of the FOCUS Diffusion's Added Clinical Value Compared to Conventional MRI With Wide Field View Diffusion in Focal Pancreatic Lesions Characterization

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.

Study Overview

Status

Completed

Conditions

Detailed Description

This diffusion sequence has shown its usefulness in pancreatic pathology in the detection and characterization of focal pancreatic lesions, particularly for neuroendocrine tumors, the evaluation of chronic and autoimmune pancreatitis or the early detection of malignant transformation of certain high-risk cystic lesions. The diffusion sequence usually performed is called "wide field" because it covers the entire abdomen. The radiologist can thus analyse the neighbouring organs and in particular the liver, which makes it essential when a pancreatic tumour is suspected because of the risk of liver metastases.

This wide-field sequence suffers from several limitations: difficulty in differentiating adenocarcinomas from chronic pseudo-mass pancreatitis due to the overlap of CDA values and difficulty in defining the boundaries of cephalic or corporal adenocarcinomas due to the hypersignal of upstream chronic obstructive pancreatitis (9)(10). Technically, it is subject to movement artifacts related to respiration, adjacent organs and in particular the duodenum, and to an average spatial resolution of the pancreas.

Over the last 10 years, a diffusion sequence called "FOCUS" has been developed allowing a reduction of the field of view in the direction of phase coding and therefore a "zoomed" image with higher resolution. This sequence has shown interest in neuroradiology and prostate cancer detection in reducing artifacts and achieving better spatial resolution than the usual "wide field" diffusion sequence. 3 minutes and 30 seconds more are required to complete this sequence.

The pancreas is a good candidate for FOCUS diffusion imaging because of its small size, susceptibility to movement artifacts and spatial orientation, allowing antero-posterior reduction of the field of view. Initial work has established the feasibility of this FOCUS diffusion in pancreatic imaging and shown an improvement in image quality (more accurate and less artefacts) in FOCUS diffusion compared to the usual "wide field".

Due to its potential in pancreatic imaging, the FOCUS diffusion sequence has been performed in current practice since 2014 in the imaging department of the Groupe Hospitalier Paris Saint-Joseph (GHPSJ) in addition to the "wide field" diffusion sequence. The protocol thus created is called "combined protocol" as opposed to "standard protocol" which does not contain the FOCUS broadcast sequence.

Kim H et al showed an improvement in the subjective clinical utility of readers in the diagnosis of benign or malignant pancreatic lesions. However, it should be noted that in this study the authors compared the two sequences by opposing them rather than comparing the usual wide-field sequence with the combination of the two sequences.

Study Type

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with benign or malignant pancreatic lesions.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy
Time Frame: Time of inclusion
Diagnostic accuracy difference between the standard protocol and the combined protocol.
Time of inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performances of benignity or malignancy
Time Frame: Time of inclusion
Differences between the standard protocol and the combined protocol in terms of sensitivity and specificity in the diagnosis of benign or malignant tumors.
Time of inclusion
Diagnostic confidence of radiologist's benign or malignant condition
Time Frame: Time of inclusion
Confidence scores assigned by radiologist
Time of inclusion
Lesions' detected number
Time Frame: Time of inclusion
Differences between the FOCUS diffusion sequence and the "wide field" sequence in terms of lesions' detected number
Time of inclusion
Image quality
Time Frame: Time of inclusion
Differences between the FOCUS diffusion sequence and the "wide field" sequence in terms of image quality
Time of inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

May 22, 2019

First Submitted That Met QC Criteria

May 22, 2019

First Posted (Actual)

May 23, 2019

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diffusion Focus

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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