Mediastinal TumorNCT03214341
Assessment of Mediastinal Masses With Diffusion Weighted MR Imaging
An observational study of Mediastinal Tumor, run by Assiut University at 1 site in Egypt.
Trial summary
Differentiation between benign and malignant mediastinal tumors as well as characterization and grading of malignancy which is essential for treatment planning as well as for prognosis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mediastinal Tumor
- What is being tested?
- MRI diffusion
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2017to 30 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with mediastinal masses
Who may be able to join
- Any age groups
- diagnosis of mediastinal mass (by Multislice Computed Tomography).
Who cannot join
- chemotherapy radiotherapy.
- thoracic surgery.
- cystic mass .
- mass with large amount of necrosis or calcification.
- contraindication of MRI (e.g. pacemakers , claustrophobia).
Trial locations and contacts
1 site in 1 country.
About this study
Differentiation between benign and malignant mediastinal tumors as well as characterization and grading of malignancy which is essential for treatment planning as well as for prognosis
Read the detailed description
Differentiation between benign and malignant mediastinal tumors as well as characterization and grading of malignancy is essential for treatment planning as well as for prognosis .
MRI presents valuable diagnostic information in assessing the mediastinum. In addition, special applications have been developed over recent years diffusion-weighted magnetic resonance imaging is one such technique The advent of echo-planar imaging technique has rendered diffusion weighted imaging of the abdomen and thoracic cavity possible .
Quantitative assessment of the mediastinal mass is possible by calculation of apparent diffusion co-efficient value ,which is related to the proportion of extracellular and intracellular component.
The apparent diffusion co-efficient is inversely correlated with tissue cellularity. It is lower in viable tumor tissue with densely packed diffusion-hindering obstacles than in tissue with less densely packed obstacles such as tumor necrosis and benign tissue .
- Conditions
- Mediastinal Tumor
- Being tested
- MRI diffusion
- Keywords
- mediastinal masses, MRI diffusion
- Medical subject headings
- Mediastinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI diffusionRadiation
using MRI diffusion to differentiate between benign and malignant mediastinal masses
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity of magnetic resonance imaging diffusion in mediastinal masses
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal TumorStudies 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Mohammed Safwat Ali, Assiut University
- Investigators
- Mostafa Thabet Hussein, professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214341
- Sponsor's protocol ID
- MRIML
- Status last verified
- Jul 2017
- First submitted
- 24 Jun 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Differentiation between benign and malignant mediastinal tumors as well as characterization and grading of malignancy which is essential for treatment planning as well as for prognosis
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Mediastinal Masses With Diffusion Weighted MR Imaging
- ClinicalTrials.gov ID
- NCT03214341
- Acronym / sponsor ID
- MRIML
- Conditions
- Mediastinal Tumor
- Keywords
- mediastinal masses, MRI diffusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 11 Jul 2017 (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.
Differentiation between benign and malignant mediastinal tumors as well as characterization and grading of malignancy which is essential for treatment planning as well as for prognosis
Detailed description
Differentiation between benign and malignant mediastinal tumors as well as characterization and grading of malignancy is essential for treatment planning as well as for prognosis .
MRI presents valuable diagnostic information in assessing the mediastinum. In addition, special applications have been developed over recent years diffusion-weighted magnetic resonance imaging is one such technique The advent of echo-planar imaging technique has rendered diffusion weighted imaging of the abdomen and thoracic cavity possible .
Quantitative assessment of the mediastinal mass is possible by calculation of apparent diffusion co-efficient value ,which is related to the proportion of extracellular and intracellular component.
The apparent diffusion co-efficient is inversely correlated with tissue cellularity. It is lower in viable tumor tissue with densely packed diffusion-hindering obstacles than in tissue with less densely packed obstacles such as tumor necrosis and benign tissue .
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with mediastinal masses
Key inclusion criteria (2 listed)
- Any age groups
- diagnosis of mediastinal mass (by Multislice Computed Tomography).
Key exclusion criteria (5 listed)
- chemotherapy radiotherapy.
- thoracic surgery.
- cystic mass .
- mass with large amount of necrosis or calcification.
- contraindication of MRI (e.g. pacemakers , claustrophobia).
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 diffusionusing MRI diffusion to differentiate between benign and malignant mediastinal masses | Radiation | – |
Primary outcome
sensitivity and specificity of magnetic resonance imaging diffusion in mediastinal masses
Time frame: up to one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- the investigator had gained some information from this siteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Differentiation between benign and malignant mediastinal tumors as well as characterization and grading of malignancy which is essential for treatment planning as well as for prognosis
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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.
Mostafa Thabet Hussein, professor principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mediastinal Tumor, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 5 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 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Noha Mohammed Ali Attia, lecturer (00201001238435, nohamohammedali@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity and specificity of magnetic resonance imaging diffusion in mediastinal masses (time frame: up to one month). 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 11 Jul 2017.