Efficacy of MRI Diffusion in Differentiation Between Benign and Malignant Bony LesionsNCT03463291
Role of MRI Diffusion in Differentiation Between Benign and Malignant Bony Lesions
An observational study of Efficacy of MRI Diffusion in Differentiation Between Benign and Malignant Bony Lesions, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Efficacy of MRI Diffusion in Differentiation Between Benign and Malignant Bony Lesions
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2018to Jul 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited outpatient clinic of Assiut General hospital and Assiut university hospital.
Who may be able to join
- All patients with bony lesions will be included in the study.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 | Role | What they receive |
|---|---|---|
| Study group | All patients with bony lesions Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ADC value of MRI diffusion in benign and malignant bony lesions ( considering ADC value <1.2 ..malignant while ADC>1.2 ..benign)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study startMay 2018 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy of MRI Diffusion in Differentiation Between Benign and Malignant Bony LesionsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A.M. Attia, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463291
- Sponsor's protocol ID
- MRIBMBL
- Status last verified
- Mar 2018
- First submitted
- 6 Mar 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of MRI Diffusion in Differentiation Between Benign and Malignant Bony Lesions
- ClinicalTrials.gov ID
- NCT03463291
- Acronym / sponsor ID
- MRIBMBL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: MRIAll patients with bony lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited outpatient clinic of Assiut General hospital and Assiut university hospital.
Key inclusion criteria (1 listed)
- All patients with bony lesions will be included in the study.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Study group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Efficacy of MRI Diffusion in Differentiation Between Benign and Malignant Bony Lesions, 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 1 inclusion and 4 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 13 Mar 2018. 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 Amr M Attia (+201270092886, hexen_22us@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2018.