Validation of a Multitask Deep Learning System at Spine M... | NCT05156567

Studies
Validation of a Multitask Deep Learning System at Spine Metastasis CT

NCT05156567

Sponsor

Shanghai 6th People's Hospital

Status

Completed

Last Update Posted

Sep 19, 2024Actual

Enrollment

280Actual

Phase

Not provided

Conditions

To Evaluate Performance of the DLS

Interventions

Deep Learning System

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Jun 1, 2024Actual

First Submitted Date

Dec 12, 2021

First Submission Date that Met QC Criteria

Dec 12, 2021

First Posted Date

Dec 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. Area under the receiver operating characteristic curve (AUC), sensitivity, and specificity of the DLS were calculated with professional graders as the reference standard.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

280Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
routine physicians
DLS			Diagnostic Test: Deep Learning System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Deep Learning System	Diagnostic Test	The multitask DLS with five algorithms detecting spine metastases and evaluate features (bone lesion quality, posterolateral involvement, and vertebral body collapse)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC	Area under the receiver operating characteristic curve (AUC) of spinal instability detection	1 months

Secondary Outcomes

Measure	Description	Time Frame
sensitivity	sensitivity of spinal instability detection	1 months
specificity	specificity of spinal instability detection	1 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pathology-proven diagnosis of solid tumor;
spinal CT scan indicating spinal metastasis with at least one lesion;
no previous surgery for spinal metastasis

Exclusion Criteria:

spinal CT scans with no sagittal reconstruction;
the radiologist considered that the quality of CT image was unqualified.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with Spine Metastasis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Sixth People's Hospital		Shanghai			China