NCT03214341

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

June 24, 2017

Last Update Submit

July 10, 2017

Conditions

Mediastinal Tumor

Keywords

mediastinal massesMRI diffusion

Outcome Measures

Primary Outcomes (1)

  • sensitivity and specificity of magnetic resonance imaging diffusion in mediastinal masses

    up to one month

Interventions

MRI diffusionRADIATION

using MRI diffusion to differentiate between benign and malignant mediastinal masses

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with mediastinal masses

You may qualify if:

  • Any age groups
  • diagnosis of mediastinal mass (by Multislice Computed Tomography).

You may not qualify if:

  • chemotherapy radiotherapy.
  • thoracic surgery.
  • cystic mass .
  • mass with large amount of necrosis or calcification.
  • contraindication of MRI (e.g. pacemakers , claustrophobia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Links

MeSH Terms

Conditions

Mediastinal Neoplasms

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Thoracic NeoplasmsNeoplasms by SiteNeoplasmsMediastinal DiseasesThoracic DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

NeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiffusion Magnetic Resonance ImagingMagnetic Resonance ImagingTomographyDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Mostafa Thabet Hussein, professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noha Mohammed Ali Attia, lecturer

CONTACT

00201001238435nohamohammedali@yahoo.com

Mostafa Thabet Hussein, professor

CONTACT

00201122999878Thabet.mostafa@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2017

First Posted

July 11, 2017

Study Start

December 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 30, 2019

Last Updated

July 11, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will share

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

Locations

EG(1)