To Evaluate Performance of the DLSNCT05156567
Validation of a Multitask Deep Learning System at Spine Metastasis CT
An observational study of To Evaluate Performance of the DLS, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
15 resident oncologists were conducted to evaluate the clinical efficacy of DLS in multicenter. They were 1:1 randomly asked to independently read the test images without the assistance of DLS software or with the assistance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- To Evaluate Performance of the DLS
- What is being tested?
- Deep Learning System
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 1 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Spine Metastasis
Who may be able to join
- pathology-proven diagnosis of solid tumor;
- spinal CT scan indicating spinal metastasis with at least one lesion;
- no previous surgery for spinal metastasis
Who cannot join
- spinal CT scans with no sagittal reconstruction;
- the radiologist considered that the quality of CT image was unqualified.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Validation of a Multitask Deep Learning System for Spine Metastases Detection Andfeatures Evaluations at Spine Metastasis CT
15 resident oncologists were conducted to evaluate the clinical efficacy of DLS in multicenter. They were 1:1 randomly asked to independently read the test images without the assistance of DLS software or with the assistance. Area under the receiver operating characteristic curve (AUC), sensitivity, and specificity of the DLS were calculated with professional graders as the reference standard.
- Conditions
- To Evaluate Performance of the DLS
- Being tested
- Deep Learning System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Learning SystemDiagnostic test
The multitask DLS with five algorithms detecting spine metastases and evaluate features (bone lesion quality, posterolateral involvement, and vertebral body collapse)
| Study group | Role | What they receive |
|---|---|---|
| routine physicians | Not described | |
| DLS | Not described Receives: Diagnostic Test: Deep Learning System |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Area under the receiver operating characteristic curve (AUC) of spinal instability detection
Measured: 1 months
Secondary outcomes (2)
sensitivity
sensitivity of spinal instability detection
Measured: 1 months
specificity
specificity of spinal instability detection
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start1 Mar 2022
- Primary completion31 Dec 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate Performance of the DLSStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
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
- NCT05156567
- Sponsor's protocol ID
- DLS01
- Status last verified
- Sep 2024
- First submitted
- 12 Dec 2021
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Validation of a Multitask Deep Learning System for Spine Metastases Detection Andfeatures Evaluations at Spine Metastasis CT
- ClinicalTrials.gov ID
- NCT05156567
- Acronym / sponsor ID
- DLS01
- Conditions
- To Evaluate Performance of the DLS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 14 Dec 2021 (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.
15 resident oncologists were conducted to evaluate the clinical efficacy of DLS in multicenter. They were 1:1 randomly asked to independently read the test images without the assistance of DLS software or with the assistance. Area under the receiver operating characteristic curve (AUC), sensitivity, and specificity of the DLS were calculated with professional graders as the reference standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine physicians | – | – |
| DLS | – | Diagnostic Test: Deep Learning System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Spine Metastasis
Key inclusion criteria (3 listed)
- pathology-proven diagnosis of solid tumor;
- spinal CT scan indicating spinal metastasis with at least one lesion;
- no previous surgery for spinal metastasis
Key exclusion criteria (2 listed)
- spinal CT scans with no sagittal reconstruction;
- the radiologist considered that the quality of CT image was unqualified.
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 |
|---|---|---|
| Deep Learning SystemThe multitask DLS with five algorithms detecting spine metastases and evaluate features (bone lesion quality, posterolateral involvement, and vertebral body collapse) | Diagnostic test | DLS |
Primary outcome
AUC
Time frame: 1 months
Area under the receiver operating characteristic curve (AUC) of spinal instability detection
2 secondary outcomes
sensitivity
Time frame: 1 months
specificity
Time frame: 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 To Evaluate Performance of the DLS, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (time frame: 1 months). 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 19 Sep 2024.