- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05079997
MAGNETIC RESONANCE IMAGING in Superficial Soft Tissue Masses
October 13, 2021 updated by: Fatma Alzahraa Mohamed Hassan Anwar, Assiut University
Role of MAGNETIC RESONANCE IMAGING in Characterization of Superficial Soft Tissue Masses
This study responds to these raise up questions: Can we use Diffusion Weighted MR complemented with numerical ADC values & in association with routine MRI in the discrimination between different malignant and benign superficial soft tissue masses.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
In the clinical practice, there is a large number & variety of superficial soft tissue masses.
The differentiation of such masses represents a major obstacle for the surgeons.
Benign &malignant neoplasms as well as non-neoplastic swellings may have similar clinical presentation.
The differentiation between malignant & benign superficial soft tissue neoplasms is required for appropriate therapeutic planning and decisions.
Masses can be characterized in terms of their size, number, component &vascularity using US and Doppler US.
However, US is operator dependent & may display a number of artifacts that can result in misinterpretation.
So MRI is superior in the assessment of such soft tissue masses due its brilliant soft tissue discrimination.
Some features that will help distinguish malignant from benign lesions are evident on MRI examination such as signal characteristics,enhancement pattern,margin,lobulation,necrosis, haemorrhage,internal septation,peritumoral edema and extension through the deep fascia .However very forcful tumors may show benign behavior & appear similar to benign masses , Thus further histopathology is required for accurate diagnosis.
Diffusion weighted MRI visualizes the random microscopic motion of molecules.
Diffusion-weighted imaging (DWI) is the technique which allows measurement of the Brownian motion of water in the tissue microenvironment depending on the organization of the tissue, integrity of cell membranes, and tortuosity of extracellular space.
Apparent Diffusion Coefficient (ADC) is a numerical parameter which is calculated from DWI.
Previously, DWI technique was used with great success in the central nervous system (CNS), in the differentiation between benign and malignant tumors in addition to its great value in early diagnosis of recent strokes.
Nowadays, DWI was used in the differentiation between malignant and benign soft tissue masses.
Malignant tumors have abundant cellularity than benign tumors hence they have more restricted diffusion.
The addition of quantitative ADC values plays a fundamental role in more accurate diagnosis of malignant superficial soft tissue neoplasms.
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fatma Alzahraa mohamed hassan
- Phone Number: 01004009026
- Email: fatma.mohamed9071995@gmail.com
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with superficial soft tissue masses
Description
Inclusion Criteria:
- patients with superficial soft tissue masses clinically
- patients underwent us detection of superficial soft tissue masses
- uncharactized superficial soft tissue mass by other modalities
Exclusion Criteria:
- MRI claustrophobia
- recurrent cases
- patients under treatment
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 |
|---|---|---|
|
benign and malignant masses
Time Frame: from october 2021 to october2022
|
The discrimination between benign and malignant superficial soft tissue mass by Non invasive available technique
|
from october 2021 to october2022
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Type of malignant superficial soft tissue masses
Time Frame: From October 2021 to October 2022
|
Differentiation type of malignant superficial soft tissue masses
|
From October 2021 to October 2022
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Local invasion of malignant superficial soft tissue masses
Time Frame: From October 2021 to October 2022
|
Detection local invasion of malignant superficial soft tissue masses
|
From October 2021 to October 2022
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Szafer A, Zhong J, Gore JC. Theoretical model for water diffusion in tissues. Magn Reson Med. 1995 May;33(5):697-712. doi: 10.1002/mrm.1910330516.
- Song Y, Yoon YC, Chong Y, Seo SW, Choi YL, Sohn I, Kim MJ. Diagnostic performance of conventional MRI parameters and apparent diffusion coefficient values in differentiating between benign and malignant soft-tissue tumours. Clin Radiol. 2017 Aug;72(8):691.e1-691.e10. doi: 10.1016/j.crad.2017.02.003. Epub 2017 Mar 6.
- Thawait GK, Subhawong TK, Tatizawa Shiga NY, Fayad LM. "Cystic"-appearing soft tissue masses: what is the role of anatomic, functional, and metabolic MR imaging techniques in their characterization? J Magn Reson Imaging. 2014 Mar;39(3):504-11. doi: 10.1002/jmri.24314. Epub 2013 Oct 22.
- Toprak H, Kilic E, Serter A, Kocakoc E, Ozgocmen S. Ultrasound and Doppler US in Evaluation of Superficial Soft-tissue Lesions. J Clin Imaging Sci. 2014 Feb 27;4:12. doi: 10.4103/2156-7514.127965. eCollection 2014.
- Calleja M, Dimigen M, Saifuddin A. MRI of superficial soft tissue masses: analysis of features useful in distinguishing between benign and malignant lesions. Skeletal Radiol. 2012 Dec;41(12):1517-24. doi: 10.1007/s00256-012-1385-6. Epub 2012 Apr 12.
- Herneth AM, Ringl H, Memarsadeghi M, Fueger B, Friedrich KM, Krestan C, Imhof H. Diffusion weighted imaging in osteoradiology. Top Magn Reson Imaging. 2007 Jun;18(3):203-12. doi: 10.1097/RMR.0b013e3180cac61d.
- Panicek DM, Gatsonis C, Rosenthal DI, Seeger LL, Huvos AG, Moore SG, Caudry DJ, Palmer WE, McNeil BJ. CT and MR imaging in the local staging of primary malignant musculoskeletal neoplasms: Report of the Radiology Diagnostic Oncology Group. Radiology. 1997 Jan;202(1):237-46. doi: 10.1148/radiology.202.1.8988217.
- Fayad LM, Jacobs MA, Wang X, Carrino JA, Bluemke DA. Musculoskeletal tumors: how to use anatomic, functional, and metabolic MR techniques. Radiology. 2012 Nov;265(2):340-56. doi: 10.1148/radiol.12111740.
- Kransdorf MJ, Murphey MD. Radiologic evaluation of soft-tissue masses: a current perspective. AJR Am J Roentgenol. 2000 Sep;175(3):575-87. doi: 10.2214/ajr.175.3.1750575. No abstract available.
- Gielen JL, De Schepper AM, Vanhoenacker F, Parizel PM, Wang XL, Sciot R, Weyler J. Accuracy of MRI in characterization of soft tissue tumors and tumor-like lesions. A prospective study in 548 patients. Eur Radiol. 2004 Dec;14(12):2320-30. doi: 10.1007/s00330-004-2431-0. Epub 2004 Jul 29.
- Kauppinen RA. Monitoring cytotoxic tumour treatment response by diffusion magnetic resonance imaging and proton spectroscopy. NMR Biomed. 2002 Feb;15(1):6-17. doi: 10.1002/nbm.742.
- Baur A, Reiser MF. Diffusion-weighted imaging of the musculoskeletal system in humans. Skeletal Radiol. 2000 Oct;29(10):555-62. doi: 10.1007/s002560000243.
- Subhawong TK, Jacobs MA, Fayad LM. Insights into quantitative diffusion-weighted MRI for musculoskeletal tumor imaging. AJR Am J Roentgenol. 2014 Sep;203(3):560-72. doi: 10.2214/AJR.13.12165.
- Padhani AR, Liu G, Koh DM, Chenevert TL, Thoeny HC, Takahara T, Dzik-Jurasz A, Ross BD, Van Cauteren M, Collins D, Hammoud DA, Rustin GJ, Taouli B, Choyke PL. Diffusion-weighted magnetic resonance imaging as a cancer biomarker: consensus and recommendations. Neoplasia. 2009 Feb;11(2):102-25. doi: 10.1593/neo.81328.
- Ross BD, Moffat BA, Lawrence TS, Mukherji SK, Gebarski SS, Quint DJ, Johnson TD, Junck L, Robertson PL, Muraszko KM, Dong Q, Meyer CR, Bland PH, McConville P, Geng H, Rehemtulla A, Chenevert TL. Evaluation of cancer therapy using diffusion magnetic resonance imaging. Mol Cancer Ther. 2003 Jun;2(6):581-7.
- Costa FM, Ferreira EC, Vianna EM. Diffusion-weighted magnetic resonance imaging for the evaluation of musculoskeletal tumors. Magn Reson Imaging Clin N Am. 2011 Feb;19(1):159-80. doi: 10.1016/j.mric.2010.10.007.
- Gonzalez RG, Schaefer PW, Buonanno FS, Schwamm LH, Budzik RF, Rordorf G, Wang B, Sorensen AG, Koroshetz WJ. Diffusion-weighted MR imaging: diagnostic accuracy in patients imaged within 6 hours of stroke symptom onset. Radiology. 1999 Jan;210(1):155-62. doi: 10.1148/radiology.210.1.r99ja02155.
- Nagata S, Nishimura H, Uchida M, Sakoda J, Tonan T, Hiraoka K, Nagata K, Akiba J, Abe T, Hayabuchi N. Diffusion-weighted imaging of soft tissue tumors: usefulness of the apparent diffusion coefficient for differential diagnosis. Radiat Med. 2008 Jun;26(5):287-95. doi: 10.1007/s11604-008-0229-8. Epub 2008 Jul 27.
- Maeda M, Matsumine A, Kato H, Kusuzaki K, Maier SE, Uchida A, Takeda K. Soft-tissue tumors evaluated by line-scan diffusion-weighted imaging: influence of myxoid matrix on the apparent diffusion coefficient. J Magn Reson Imaging. 2007 Jun;25(6):1199-204. doi: 10.1002/jmri.20931.
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 (ANTICIPATED)
October 1, 2021
Primary Completion (ANTICIPATED)
October 1, 2022
Study Completion (ANTICIPATED)
March 1, 2023
Study Registration Dates
First Submitted
September 26, 2021
First Submitted That Met QC Criteria
October 13, 2021
First Posted (ACTUAL)
October 15, 2021
Study Record Updates
Last Update Posted (ACTUAL)
October 15, 2021
Last Update Submitted That Met QC Criteria
October 13, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- mri in soft tissue
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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