Detection of Bone Marrow Metastases With Magnetic Resonance Imaging

Not Applicable

• Conditions: Magnetic Resonance Imaging; Bone Marrow Metastases
• Interventions: Diagnostic Test: magnetic resonance imaging

• Registration Number: NCT03876392
• Lead Sponsor: Shanghai 6th People's Hospital

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.

Study Timeline

• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Study Start: 2019-05-10
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-09
• Last Update Posted: 2021-08-12
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients with malignant tumors (solid tumors or hematological malignancies) were definitely diagnosed by pathology or cytology.
2. patients with bone metastases confirmed by more than two imaging examinations.
3. Age 18-75.
4. ECOG score: 0-2.
5. The expected survival time is more than 3 months.
6. Sign the informed consent.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
magnetic resonance imaging	magnetic resonance imaging	Detection of bone marrow metastases with magnetic resonance imaging

Primary Outcome Measures

Name	Time	Method
specificity	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	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

Trial Locations

Locations (1)

Shanghai Sixth People'S Hospital; 🇨🇳 Shanghai, Other (Non U.s.), China