Spinal TumorNCT05631002
Chemical Shift Encoding-based Water-fat Magnetic Resonance Imaging in Spinal Tumors
An observational study of Spinal Tumor and Bone Tumor, run by Peking University Third Hospital at 1 site in China.
Trial summary
Fat composition of the spinal tumors is positively correlated with classification and differential diagnosis of benign and malignant tumors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Tumor, Bone Tumor
- What is being tested?
- Chemical shift encoding-based water-fat MRI
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Dec 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults with spinal tumors
Who may be able to join
- Pathological biopsy of a patient with diagnosed spinal tumor lesion, and preoperative examination Chemical shift encoding-based water-fat MRI was performed.
Who cannot join
- Recurrent neoplasms; Lesion diameter < 1 cm; Poor image quality.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University third hospital
Beijing, Beijing Municipality, 100089
Ning Lang, +861082265571, langning800129@126.com
About this study
Fat composition of the spinal tumors is positively correlated with classification and differential diagnosis of benign and malignant tumors.
Read the detailed description
Chemical shift encoding-based water-fat magnetic resonance imaging (MRI) is a non-invasive method that provides quantitative information about the biochemical water-fat composition of bone marrow and skeletal muscle in vivo.
- Conditions
- Spinal Tumor, Bone Tumor
- Being tested
- Chemical shift encoding-based water-fat MRI
- Medical subject headings
- Spinal Cord Neoplasms, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemical shift encoding-based water-fat MRIDiagnostic test
Chemical shift encoding-based water-fat magnetic resonance imaging (MRI): a non-invasive method
| Study group | Role | What they receive |
|---|---|---|
| Patients with benign spinal tumor | Not described Receives: Diagnostic Test: Chemical shift encoding-based water-fat MRI | |
| Patients with intermediate spinal tumor | Not described Receives: Diagnostic Test: Chemical shift encoding-based water-fat MRI | |
| Patients with malignant spinal tumor | Not described Receives: Diagnostic Test: Chemical shift encoding-based water-fat MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of tumor
Pathological diagnosis
Measured: One month before treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start1 Aug 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal TumorStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ning Lang, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631002
- Sponsor's protocol ID
- M2022403
- Status last verified
- Aug 2022
- First submitted
- 20 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemical Shift Encoding-based Water-fat Magnetic Resonance Imaging in Spinal Tumors
- ClinicalTrials.gov ID
- NCT05631002
- Acronym / sponsor ID
- M2022403
- Conditions
- Spinal Tumor, Bone Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Nov 2022 (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.
Fat composition of the spinal tumors is positively correlated with classification and differential diagnosis of benign and malignant tumors.
Detailed description
Chemical shift encoding-based water-fat magnetic resonance imaging (MRI) is a non-invasive method that provides quantitative information about the biochemical water-fat composition of bone marrow and skeletal muscle in vivo.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with benign spinal tumor | – | Diagnostic Test: Chemical shift encoding-based water-fat MRI |
| Patients with intermediate spinal tumor | – | Diagnostic Test: Chemical shift encoding-based water-fat MRI |
| Patients with malignant spinal tumor | – | Diagnostic Test: Chemical shift encoding-based water-fat MRI |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults with spinal tumors
Key inclusion criteria (1 listed)
- Pathological biopsy of a patient with diagnosed spinal tumor lesion, and preoperative examination Chemical shift encoding-based water-fat MRI was performed.
Key exclusion criteria (1 listed)
- Recurrent neoplasms; Lesion diameter < 1 cm; Poor image quality.
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 |
|---|---|---|
| Chemical shift encoding-based water-fat MRIChemical shift encoding-based water-fat magnetic resonance imaging (MRI): a non-invasive method | Diagnostic test | Patients with benign spinal tumor, Patients with intermediate spinal tumor, Patients with malignant spinal tumor |
Primary outcome
Type of tumor
Time frame: One month before treatment
Pathological diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
Ning Lang study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Tumor and Bone Tumor, run by Peking University Third 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 1 inclusion and 1 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 30 Nov 2022. 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?
Contact Qizheng Wang (13161593501, wangqizheng96@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of tumor (time frame: One month before treatment). 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 30 Nov 2022.