NCT03463291

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.

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 May 2018

Typical duration for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

March 6, 2018

Last Update Submit

March 10, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Study group

All patients with bony lesions

Device: MRI

Interventions

MRIDEVICE

* 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.

Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 6, 2018

First Posted

March 13, 2018

Study Start

May 1, 2018

Primary Completion

May 1, 2020

Study Completion

July 1, 2020

Last Updated

March 13, 2018

Record last verified: 2018-03