NCT03876392

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 10, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

3.6 years

First QC Date

March 4, 2019

Last Update Submit

August 9, 2021

Conditions

Bone Marrow MetastasesMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

magnetic resonance imaging

EXPERIMENTAL

Detection of bone marrow metastases with magnetic resonance imaging

Diagnostic Test: magnetic resonance imaging

Interventions

magnetic resonance imagingDIAGNOSTIC_TEST

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

magnetic resonance imaging

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Sixth People'S Hospital

Shanghai, Other (Non U.s.), 200233, China

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 15, 2019

Study Start

May 10, 2019

Primary Completion

December 1, 2022

Study Completion

December 31, 2022

Last Updated

August 12, 2021

Record last verified: 2021-08

Locations

CN(1)