Detection of Bone Marrow Metastases With Magnetic Resonance Imaging

NCT ID: NCT03876392

Last Updated: 2021-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-10

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Bone Marrow Metastases Magnetic Resonance Imaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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magnetic resonance imaging

Detection of bone marrow metastases with magnetic resonance imaging

Group Type EXPERIMENTAL

magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

Compare bone marrow biopsy with magnetic resonance imaging to detect bone marrow metastases

Interventions

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magnetic resonance imaging

Compare bone marrow biopsy with magnetic resonance imaging to detect bone marrow metastases

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 6th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhao Hui

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Sixth People'S Hospital

Shanghai, Other (Non U.s.), China

Site Status RECRUITING

Countries

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China

Facility Contacts

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hui zhao, phD

Role: primary

Other Identifiers

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MRI001

Identifier Type: -

Identifier Source: org_study_id

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