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AzTrials

Soft Tissue MassesNCT05079997

MAGNETIC RESONANCE IMAGING in Superficial Soft Tissue Masses

An observational study of Soft Tissue Masses, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Soft Tissue Masses
What is being tested?
MAGNETIC RESONANCE IMAGING
Type of treatment
Medical device
How many people
50 participants
Where
No sites listed yet
Study dates
Oct 2021to Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: patients with superficial soft tissue masses

Who may be able to join

  • patients with superficial soft tissue masses clinically
  • patients underwent us detection of superficial soft tissue masses
  • uncharactized superficial soft tissue mass by other modalities

Who cannot join

  • MRI claustrophobia
  • recurrent cases
  • patients under treatment

Trial locations and contacts

No sites are listed yet.

Fatma Alzahraa mohamed hassan contact

01004009026

fatma.mohamed9071995@gmail.com

About this study

Official title: 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.

Read the 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.

Being tested
MAGNETIC RESONANCE IMAGING

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MAGNETIC RESONANCE IMAGINGDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. benign and malignant masses

    The discrimination between benign and malignant superficial soft tissue mass by Non invasive available technique

    Measured: from october 2021 to october2022

Secondary outcomes (1)

  1. Type of malignant superficial soft tissue masses

    Differentiation type of malignant superficial soft tissue masses

    Measured: From October 2021 to October 2022

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2021
  2. Study startOct 2021 (estimated)
  3. Primary completionOct 2022 (estimated)
  4. Study completionMar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05079997
Sponsor's protocol ID
mri in soft tissue
Status last verified
Oct 2021
First submitted
26 Sep 2021
Last updated
15 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28274509

  • 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.

    PubMed 24532375

  • 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.

    PubMed 24744969

  • 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.

    PubMed 22491777

  • 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.

    PubMed 17762384

  • 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.

    PubMed 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.

    PubMed 23093707

  • 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.

    PubMed 10954433

  • 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.

    PubMed 15290067

  • 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.

    PubMed 11840548

  • 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.

    PubMed 11127677

  • 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.

    PubMed 7596275

  • 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.

    PubMed 25148158

  • 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.

    PubMed 19186405

  • 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.

    PubMed 12813138

Questions about this trial

What is this clinical trial studying?

An observational study of Soft Tissue Masses, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fatma Alzahraa mohamed hassan (01004009026, fatma.mohamed9071995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

benign and malignant masses (time frame: from october 2021 to october2022). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05079997, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.

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