CClinicalTrials.gg
Status unknownNCT03746561ASSISTUpdated Nov 19, 2018

Automatic Diagnosis of Spinal Stenosis on CT

An observational study in Spinal Stenosis, sponsored by Shanghai 10th People's Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-19.

Sponsored by Shanghai 10th People's Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
500
Ages
18 Years and older
Sex
All
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Study summary

MRI is a common tool for radiographic diagnosis of spinal stenosis, but it is expensive and requires long scanning time. CT is also a useful tool to diagnose spinal stenosis, yet interpretation can be time-consuming with high inter-reader variability even among the most specialized radiologists. In this study, the investigators aim to develop a deep-learning algorithm to automatically detect and classify lumbar spinal stenosis.

Read the detailed description

MRI is a common tool for radiographic diagnosis of spinal stenosis, but it is expensive and requires long scanning time. CT is also a useful tool to diagnose spinal stenosis, yet interpretation can be time-consuming with high inter-reader variability even among the most specialized radiologists. In this study, the investigators aim to develop a deep-learning algorithm to automatically detect and classify lumbar spinal stenosis. It would be a time-saving workflow if the software can assist the radiologists to detect and locate the suspected lesion.

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Conditions studied

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In context

Spinal Stenosis

459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.

This study's planned enrollment of 500 is above the median of 116 across 152 observational studies indexed under Spinal Stenosis.

Browse Spinal Stenosis studies →

Lead sponsor

Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Spinal stenosis is a narrowing of the spaces within the spine, which can put pressure on the nerves that travel through the spine. Spinal stenosis occurs most often in the back, the neck, and sometimes the thoracic spine.

Some people with spinal stenosis may not have symptoms. Others may experience pain, tingling, numbness and muscle weakness. Symptoms can worsen over time.

Inclusion criteria

  • Age >18 years
  • with radiologists' CT reports on cervical, thoracic and lumbar stenosis

Exclusion criteria

Exclusion Criteria:

  • not applicable (only specific levels with extensive infections, fractures, tumor, high-grade spondylolisthesis would be excluded for analysis).
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • spinal stenosis

    Spinal stenosis is a narrowing of the spaces within your spine, which can put pressure on the nerves that travel through the spine. Spinal stenosis occurs most often in the lower back and the neck.

    Diagnostic Test: deep learning

Interventions

  • Diagnostic testdeep learning

    detect and classify spinal stenosis by deep learning

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What researchers measure

Primary outcomes

  1. diagnostic accuracy of deep learning

    Diagnostic accuracy of deep learning to determine spinal stenosis compared with radiologists' labels based on CT

    Time frame: 1 day

Secondary outcomes

  1. Diagnostic Performance of deep learning

    Sensitivity, specificity, positive predictive value and negative predictive value of deep learning compared with radiologists' labels based on CT

    Time frame: 1 day

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03746561
Lead sponsor
Shanghai 10th People's Hospital
Collaborators
Brigham and Women's Hospital, Shanghai East Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
Responsible party
Shisheng He, MD (Deputy Director of Orthopedic Department, Shanghai 10th People's Hospital) — Principal investigator
First posted
Nov 19, 2018
Start date
Nov 2018 (estimated)
Primary completion
Apr 2019 (estimated)
Completion
May 2019 (estimated)
Last update
Nov 19, 2018

Study contacts

Shisheng He, MD
Contact
TJHSS7418@TONGJI.EDU.CN
021-66307580
GUOXIN FAN, MD
Contact
GFAN@TONGJI.EDU.CN
021-66307580

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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