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Role of MRI Diffusion in Differentiation Between Benign and Malignant Bony Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03463291
Recruitment Status : Unknown
Verified March 2018 by A.M. Attia, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
A.M. Attia, Assiut University

Study Description
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Brief Summary:

Bone tumors are categorized according to their tissue of origin into cartilagenous, osteogenic, fibrogenic, fibrohistiocytic, haematopoietic, vascular, and lipogenic tumors.

Magnetic resonance imaging (MRI) is now indispensable for the preoperative workup and therapeutic follow-up of patients with musculoskeletal tumors.

The application of DW-MRI in bone marrow is today an established examination technique that provides a unique contrast and that can help in the detection of bone-marrow pathologies and the differentiation of benign and malignant bone-marrow lesions.

Diffusion MRI provides quantitative and qualitative assessments of tissue cellularity and cell-membrane integrity. It is widely used for tumour detection, characterisation, and monitoring during treatment. Diffusion MRI supplies functional information that complements the structural evaluation.

In combination with standard structural MRI parameters, the ADC value improves tumour characterization. Diffusion MRI can also be used to monitor tumours during chemotherapy. Tumour necrosis results in loss of cell membrane integrity and in expansion of the extracellular compartment, leading to greater water-molecule diffusion with an increase in the ADC value.


Condition or disease Intervention/treatment
Efficacy of MRI Diffusion in Differentiation Between Benign and Malignant Bony Lesions Device: MRI

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Role of MRI Diffusion in Differentiation Between Benign and Malignant Bony Lesions
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
Study group
All patients with bony lesions
 Device: MRI
  • T1 weighted image.
  • Fast spin-echoT2 weighted image.
  • Short inversion recovery (STIR).
  • T1-fat suppressed images.
  • Diffusion weighted sequences with different b values 0-1000 s/mm2 with qualitative assessments by the different b values as well as quantitative assessment by measurement of the ADC values.


Outcome Measures
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Primary Outcome Measures :
  1. The ADC value of MRI diffusion in benign and malignant bony lesions ( considering ADC value <1.2 ..malignant while ADC>1.2 ..benign) [ Time Frame: 1 day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients will be recruited outpatient clinic of Assiut General hospital and Assiut university hospital.
Criteria

Inclusion Criteria:

  • All patients with bony lesions will be included in the study.

Exclusion Criteria:

  • Patient with cardiac pacemaker.
  • Patients with metallic prosthesis in the region of examination.
  • Patients with claustrophobia.
  • Patient with recent history of surgical or imagining guided biopsy from the bony lesion.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463291


Contacts
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Contact: Amr M Attia +201270092886 hexen_22us@yahoo.com

Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: A.M. Attia, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03463291    
Other Study ID Numbers: MRIBMBL
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No