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Trial record 17 of 1802 for:    "bone marrow" | Recruiting, Not yet recruiting Studies

Detection of Bone Marrow Metastases With Magnetic Resonance Imaging

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ClinicalTrials.gov Identifier: NCT03876392
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Zhao Hui, Shanghai 6th People's Hospital

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

Condition or disease Intervention/treatment Phase
Bone Marrow Metastases Magnetic Resonance Imaging Diagnostic Test: magnetic resonance imaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Detection of Bone Marrow Metastases With Magnetic Resonance Imaging
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: magnetic resonance imaging
Detection of bone marrow metastases with magnetic resonance imaging
Diagnostic Test: magnetic resonance imaging
Compare bone marrow biopsy with magnetic resonance imaging to detect bone marrow metastases




Primary Outcome Measures :
  1. sensitivity [ Time Frame: through study completion, an average of 1 year ]
    With bone marrow biopsy as the gold standard, the sensitivity of functional MRI in the diagnosis of bone marrow metastasis

  2. specificity [ Time Frame: through study completion, an average of 1 year ]
    With bone marrow biopsy as the gold standard, the specificity of functional MRI in the diagnosis of bone marrow metastasis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Zhao Hui, professor, Shanghai 6th People's Hospital
ClinicalTrials.gov Identifier: NCT03876392     History of Changes
Other Study ID Numbers: MRI001
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

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

Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes