Bone Marrow MetastasesNCT03876392
Detection of Bone Marrow Metastases With Magnetic Resonance Imaging
A study testing magnetic resonance imaging in people with Bone Marrow Metastases and Magnetic Resonance Imaging, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to study the value and feasibility of magnetic resonance imaging in detection of bone marrow metastases Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bone Marrow Metastases, Magnetic Resonance Imaging
- What is being tested?
- magnetic resonance imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People'S Hospital
Shanghai, Other (Non U.s.), 200233
hui zhao, phD, 1, ivy25502@hotmail.com
About this study
The goal of this clinical trial is to study the value and feasibility of magnetic resonance imaging in detection of bone marrow metastases
Read the 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.
- Conditions
- Bone Marrow Metastases, Magnetic Resonance Imaging
- Being tested
- magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingDiagnostic test
Compare bone marrow biopsy with magnetic resonance imaging to detect bone marrow metastases
| Study group | Role | What they receive |
|---|---|---|
| magnetic resonance imaging | Experimental | Detection of bone marrow metastases with magnetic resonance imaging Receives: Diagnostic Test: magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity
With bone marrow biopsy as the gold standard, the sensitivity of functional MRI in the diagnosis of bone marrow metastasis
Measured: 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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start10 May 2019
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Hui, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876392
- Sponsor's protocol ID
- MRI001
- Status last verified
- Aug 2021
- First submitted
- 4 Mar 2019
- Last updated
- 12 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Bone Marrow Metastases With Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT03876392
- Acronym / sponsor ID
- MRI001
- Conditions
- Bone Marrow Metastases, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| magnetic resonance imaging | Experimental | Diagnostic Test: magnetic resonance imagingDetection of bone marrow metastases with magnetic resonance imaging |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic resonance imagingCompare bone marrow biopsy with magnetic resonance imaging to detect bone marrow metastases | Diagnostic test | magnetic resonance imaging |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance imaging in people with Bone Marrow Metastases and Magnetic Resonance Imaging, run by Shanghai 6th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.