NCT05079997

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

September 26, 2021

Last Update Submit

October 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • benign and malignant masses

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

    from october 2021 to october2022

Secondary Outcomes (1)

  • Type of malignant superficial soft tissue masses

    From October 2021 to October 2022

Other Outcomes (1)

  • Local invasion of malignant superficial soft tissue masses

    From October 2021 to October 2022

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with superficial soft tissue masses

You may qualify if:

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

You may not qualify if:

  • MRI claustrophobia
  • recurrent cases
  • patients under treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (19)

  • 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.

    PMID: 28274509BACKGROUND
  • 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.

    PMID: 24532375BACKGROUND
  • 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.

    PMID: 24744969BACKGROUND
  • 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.

    PMID: 22491777BACKGROUND
  • 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.

    PMID: 17762384BACKGROUND
  • 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.

    PMID: 8988217BACKGROUND
  • 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.

    PMID: 23093707BACKGROUND
  • 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.

    PMID: 10954433BACKGROUND
  • 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.

    PMID: 15290067BACKGROUND
  • 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.

    PMID: 11840548BACKGROUND
  • 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.

    PMID: 11127677BACKGROUND
  • 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.

    PMID: 7596275BACKGROUND
  • 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.

    PMID: 25148158BACKGROUND
  • 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.

    PMID: 19186405BACKGROUND
  • 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.

    PMID: 12813138BACKGROUND
  • 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.

    PMID: 21129640BACKGROUND
  • 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.

    PMID: 9885601BACKGROUND
  • 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.

    PMID: 18661213BACKGROUND
  • 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.

    PMID: 17520732BACKGROUND

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Fatma Alzahraa mohamed hassan

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

September 26, 2021

First Posted

October 15, 2021

Study Start

October 1, 2021

Primary Completion

October 1, 2022

Study Completion

March 1, 2023

Last Updated

October 15, 2021

Record last verified: 2021-10