Detection of Bone Marrow Metastases With Magnetic Resonan... | NCT03876392

Studies
Detection of Bone Marrow Metastases With Magnetic Resonance Imaging

NCT03876392

Sponsor

Shanghai 6th People's Hospital

Status

Unknown status

Last Update Posted

Aug 12, 2021Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Bone Marrow Metastases
Magnetic Resonance Imaging

Interventions

magnetic resonance imaging

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2019Actual

Primary Completion Date

Dec 1, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Mar 4, 2019

First Submission Date that Met QC Criteria

Mar 13, 2019

First Posted Date

Mar 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2021

Last Update Posted Date

Aug 12, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
magnetic resonance imaging	Experimental	Detection of bone marrow metastases with magnetic resonance imaging	Diagnostic Test: magnetic resonance imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
magnetic resonance imaging	Diagnostic Test	Compare bone marrow biopsy with magnetic resonance imaging to detect bone marrow metastases	magnetic resonance imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Sixth People'S Hospital	Recruiting	Shanghai	Other (Non U.s.)	200233	China

Intervention Browse Module

MeSH Terms

ID	Term
D008279	Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

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Browse Branches

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