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Detection of Bone Marrow Metastases With Magnetic Resonance Imaging

Primary Purpose

Bone Marrow Metastases, Magnetic Resonance Imaging

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
magnetic resonance imaging
Sponsored by
Shanghai 6th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bone Marrow Metastases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Sixth People'S HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

magnetic resonance imaging

Arm Description

Detection of bone marrow metastases with magnetic resonance imaging

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 4, 2019
Last Updated
August 9, 2021
Sponsor
Shanghai 6th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03876392
Brief Title
Detection of Bone Marrow Metastases With Magnetic Resonance Imaging
Official Title
Detection of Bone Marrow Metastases With Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 6th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Marrow Metastases, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
magnetic resonance imaging
Arm Type
Experimental
Arm Description
Detection of bone marrow metastases with magnetic resonance imaging
Intervention Type
Diagnostic Test
Intervention Name(s)
magnetic resonance imaging
Intervention Description
Compare bone marrow biopsy with magnetic resonance imaging to detect bone marrow metastases
Primary Outcome Measure Information:
Title
sensitivity
Description
With bone marrow biopsy as the gold standard, the sensitivity of functional MRI in the diagnosis of bone marrow metastasis
Time Frame
through study completion, an average of 1 year
Title
specificity
Description
With bone marrow biopsy as the gold standard, the specificity of functional MRI in the diagnosis of bone marrow metastasis
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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. Age 18-75. ECOG score: 0-2. 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.
Facility Information:
Facility Name
Shanghai Sixth People'S Hospital
City
Shanghai
State/Province
Other (Non U.s.)
ZIP/Postal Code
200233
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hui zhao, phD
Phone
1
Email
ivy25502@hotmail.com

12. IPD Sharing Statement

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Detection of Bone Marrow Metastases With Magnetic Resonance Imaging

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