MAGNETIC RESONANCE IMAGING in Superficial Soft Tissue Masses

NCT ID: NCT05079997

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-31

Study Completion Date

2023-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Soft Tissue Masses

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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MAGNETIC RESONANCE IMAGING

s a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body. MRI scanners use strong magnetic fields, magnetic field gradients, and radio waves to generate images of the organs in the body. MRI does not involve X-rays or the use of ionizing radiation, which distinguishes it from CT and PET scans. MRI is a medical application of nuclear magnetic resonance (NMR) which can also be used for imaging in other NMR applications, such as NMR spectroscopy.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Alzahraa Mohamed Hassan Anwar

resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Fatma Alzahraa mohamed hassan

Role: CONTACT

01004009026

References

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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.

Reference Type BACKGROUND
PMID: 28274509 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24532375 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24744969 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22491777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17762384 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8988217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23093707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10954433 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15290067 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11840548 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11127677 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7596275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25148158 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19186405 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12813138 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21129640 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9885601 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18661213 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17520732 (View on PubMed)

Other Identifiers

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mri in soft tissue

Identifier Type: -

Identifier Source: org_study_id