Validation of a Multitask Deep Learning System at Spine Metastasis CT

• Sponsor: Shanghai 6th People's Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05156567
• Collaborator: (none)
• Enrollment: 420
• Anticipated Duration (Months): 18

Study Details

Study Description

Brief Summary

The multitask deep learning system (DLS) with five algorithms detecting five quantitative factors of Spinal Instability Neoplastic Score (SINS) was developed. Radiologists and oncologists from multicenter will be recruited to read the CT scans in picture archiving and communication system (PACS) independently, comparing with the DLS. One month after reading the CT scans in PACS, the participants will also asked to perform a web-based test in the DLS website using the same CT scans. Area under the receiver operating characteristic curve (AUC), sensitivity, and specificity of the DLS were calculated with professional graders as the reference standard.

Condition or Disease	Intervention/Treatment	Phase
To Evaluate the Spinal Instability Detection Performance of the DLS	Diagnostic Test: Deep Learning System

Study Design

• Study Type: Observational
• Anticipated Enrollment: 420 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Multicenter Validation of a Multitask Deep Learning System for Spinal Instability at Spine Metastasis CT
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
routine physicians	Diagnostic Test: Deep Learning System; The multitask DLS with five algorithms detecting five quantitative factors of SINS
DLS	Diagnostic Test: Deep Learning System; The multitask DLS with five algorithms detecting five quantitative factors of SINS

Outcome Measures

Primary Outcome Measures

1. AUC [1 months]

   Area under the receiver operating characteristic curve (AUC) of spinal instability detection

Secondary Outcome Measures

1. sensitivity [1 months]

   sensitivity of spinal instability detection

2. specificity [1 months]

   specificity of spinal instability detection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. pathology-proven diagnosis of solid tumor;

2. spinal CT scan indicating spinal metastasis with at least one lesion;

3. no previous surgery for spinal metastasis

Exclusion Criteria:

1. spinal CT scans with no sagittal reconstruction;

2. the radiologist considered that the quality of CT image was unqualified.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai 6th People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhao Hui, Dr, Shanghai 6th People's Hospital
• ClinicalTrials.gov Identifier: NCT05156567
• Other Study ID Numbers: DLS01
• First Posted: Dec 14, 2021
• Last Update Posted: Jun 1, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasm Metastasis

Study Results

No Results Posted as of Jun 1, 2022