Clinical trial · Observational
Evaluation of the FOCUS Diffusion's Added Clinical Value Compared to Conventional MRI
Evaluation of the FOCUS Diffusion's Added Clinical Value Compared to Conventional MRI With Wide Field View Diffusion in Focal Pancreatic Lesions Characterization
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Pancreas | Malignant Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic accuracy
- timeFrame
- Time of inclusion
- description
- Diagnostic accuracy difference between the standard protocol and the combined protocol.
Secondary outcomes (4)
- measure
- Diagnostic performances of benignity or malignancy
- timeFrame
- Time of inclusion
- description
- Differences between the standard protocol and the combined protocol in terms of sensitivity and specificity in the diagnosis of benign or malignant tumors.
- measure
- Diagnostic confidence of radiologist's benign or malignant condition
- timeFrame
- Time of inclusion
- description
- Confidence scores assigned by radiologist
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (17)
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- BACKGROUNDKoh DM, Collins DJ. Diffusion-weighted MRI in the body: applications and challenges in oncology. AJR Am J Roentgenol. 2007 Jun;188(6):1622-35. doi: 10.2214/AJR.06.1403. PMID 17515386
- BACKGROUNDBarral M, Taouli B, Guiu B, Koh DM, Luciani A, Manfredi R, Vilgrain V, Hoeffel C, Kanematsu M, Soyer P. Diffusion-weighted MR imaging of the pancreas: current status and recommendations. Radiology. 2015 Jan;274(1):45-63. doi: 10.1148/radiol.14130778. PMID 25531479
- BACKGROUNDPark MJ, Kim YK, Choi SY, Rhim H, Lee WJ, Choi D. Preoperative detection of small pancreatic carcinoma: value of adding diffusion-weighted imaging to conventional MR imaging for improving confidence level. Radiology. 2014 Nov;273(2):433-43. doi: 10.1148/radiol.14132563. Epub 2014 Jul 4. PMID 24991989
- BACKGROUNDd'Assignies G, Fina P, Bruno O, Vullierme MP, Tubach F, Paradis V, Sauvanet A, Ruszniewski P, Vilgrain V. High sensitivity of diffusion-weighted MR imaging for the detection of liver metastases from neuroendocrine tumors: comparison with T2-weighted and dynamic gadolinium-enhanced MR imaging. Radiology. 2013 Aug;268(2):390-9. doi: 10.1148/radiol.13121628. Epub 2013 Mar 26. PMID 23533288
- BACKGROUNDMotosugi U, Ichikawa T, Morisaka H, Sou H, Muhi A, Kimura K, Sano K, Araki T. Detection of pancreatic carcinoma and liver metastases with gadoxetic acid-enhanced MR imaging: comparison with contrast-enhanced multi-detector row CT. Radiology. 2011 Aug;260(2):446-53. doi: 10.1148/radiol.11103548. Epub 2011 Jun 21. PMID 21693662
- BACKGROUNDKim 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.