Detection of Bone Marrow Metastases With Magnetic Resonance Imaging

Magnetic Resonance Imaging Clinical Trial

Official title:

Detection of Bone Marrow Metastases With Magnetic Resonance Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03876392
• Other study ID #: MRI001
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: Shanghai 6th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Metastases
• Magnetic Resonance Imaging
• Neoplasm Metastasis

Intervention

Diagnostic Test:
• magnetic resonance imaging
Compare bone marrow biopsy with magnetic resonance imaging to detect bone marrow metastases

Locations

Country	Name	City	State
China	Shanghai Sixth People'S Hospital	Shanghai	Other (Non U.s.)

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 6th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity	With bone marrow biopsy as the gold standard, the sensitivity of functional MRI in the diagnosis of bone marrow metastasis	through study completion, an average of 1 year
Primary	specificity	With bone marrow biopsy as the gold standard, the specificity of functional MRI in the diagnosis of bone marrow metastasis	through study completion, an average of 1 year