NCT05110430

Brief Summary

Bone scintigraphy scans are two dimensional medical images that are used heavily in nuclear medicine. The scans detect changes in bone metabolism with high sensitivity, yet it lacks the specificity to underlying causes. Therefore, further imaging would be required to confirm the underlying cause. The aim of this study is to investigate whether deep learning can improve clinical decision based on bone scintigraphy scans.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,365

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 19, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

April 19, 2021

Last Update Submit

March 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The classification performance of DL algorithm compared to the ground truth

    Reporting the performance measures (Area under the curve, accuracy, specificity..etc)

    June 2021

Secondary Outcomes (1)

  • Comparing the classification performance of the DL algorithm to that of physicians

    June 2021

Study Arms (3)

BS-UKA

Patients who underwent bone scintigraphy scanning between 2010 and 2018 at RTWH Aachen university hospital, and had a bone scan report that indicates the presence or absence of metastatic bone disease.

Other: Deep learning based detection of metastatic bone disease on bone scintigraphy scans.

BS-Namur

Patients who underwent bone scintigraphy scanning between 2010 and 2018 at Namur university hospital, and had a bone scan report that indicates the presence or absence of metastatic bone disease.

Other: Deep learning based detection of metastatic bone disease on bone scintigraphy scans.

BS-Aalborg

Patients who underwent bone scintigraphy scanning between 2010 and 2018 at Aalborg university hospital, and had a bone scan report that indicates the presence or absence of metastatic bone disease.

Other: Deep learning based detection of metastatic bone disease on bone scintigraphy scans.

Interventions

The aim is to investigate whether deep learning algorithms can detect bone metastasis with high accuracy and specificity.

BS-AalborgBS-NamurBS-UKA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient who had an indication for undergoing bone scintigraphy in any of the participating centers.

You may qualify if:

  • Patients who underwent a bone scintigraphy scan that is available with the radiologic report between 2010-2018

You may not qualify if:

  • The lack of a bone scan, or corresponding radiologic report

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Location

Related Publications (1)

  • Ibrahim A, Vaidyanathan A, Primakov S, Belmans F, Bottari F, Refaee T, Lovinfosse P, Jadoul A, Derwael C, Hertel F, Woodruff HC, Zacho HD, Walsh S, Vos W, Occhipinti M, Hanin FX, Lambin P, Mottaghy FM, Hustinx R. Deep learning based identification of bone scintigraphies containing metastatic bone disease foci. Cancer Imaging. 2023 Jan 25;23(1):12. doi: 10.1186/s40644-023-00524-3.

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2021

First Posted

November 8, 2021

Study Start

March 10, 2021

Primary Completion

December 30, 2021

Study Completion

December 31, 2021

Last Updated

March 20, 2023

Record last verified: 2023-03

Locations