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

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.

Study Overview

• Status: Unknown
• Conditions: Efficacy of MRI Diffusion in Differentiation Between Benign and Malignant Bony Lesions
• Intervention / Treatment: Device: MRI

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients will be recruited outpatient clinic of Assiut General hospital and Assiut university hospital.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2018
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: March 6, 2018
• First Submitted That Met QC Criteria: March 10, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2018
• Last Update Submitted That Met QC Criteria: March 10, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: MRIBMBL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No