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Clinical Trials/NCT03876392
NCT03876392
Unknown
Not Applicable

Detection of Bone Marrow Metastases With Magnetic Resonance Imaging

Shanghai 6th People's Hospital1 site in 1 country50 target enrollmentMay 10, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bone Marrow Metastases
Sponsor
Shanghai 6th People's Hospital
Enrollment
50
Locations
1
Primary Endpoint
specificity
Last Updated
4 years ago

Overview

Brief Summary

The goal of this clinical trial is to study the value and feasibility of magnetic resonance imaging in detection of bone marrow metastases

Detailed Description

The patient was diagnosed as bone metastasis by pathology. CT showed no bone marrow biopsy site metastasis (anterior iliac spine or posterior iliac spine). After functional magnetic resonance examination, bone marrow biopsy was performed. Functional magnetic resonance imaging includes conventional SE sequence, T2W SPAIR, e-THRIVE,DWI,IVIM. With bone marrow biopsy as the gold standard, the sensitivity, specificity and coincidence rate of functional MRI in the diagnosis of bone marrow metastasis were evaluated.

Registry
clinicaltrials.gov
Start Date
May 10, 2019
End Date
December 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zhao Hui

professor

Shanghai 6th People's Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with malignant tumors (solid tumors or hematological malignancies) were definitely diagnosed by pathology or cytology.
  • patients with bone metastases confirmed by more than two imaging examinations.
  • ECOG score: 0-
  • The expected survival time is more than 3 months.
  • Sign the informed consent.

Exclusion Criteria

  • Imaging findings suggest that bone metastases are present at the bone marrow puncture site.
  • The patient refused bone marrow puncture.
  • Puncture site with infection.
  • Severe coagulation dysfunction.
  • There are implanted instruments in the body, so magnetic resonance imaging can not be performed.

Outcomes

Primary Outcomes

specificity

Time Frame: through study completion, an average of 1 year

With bone marrow biopsy as the gold standard, the specificity of functional MRI in the diagnosis of bone marrow metastasis

sensitivity

Time Frame: through study completion, an average of 1 year

With bone marrow biopsy as the gold standard, the sensitivity of functional MRI in the diagnosis of bone marrow metastasis

Study Sites (1)

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