NCT05628792

Brief Summary

To evaluate the image quality and ability to depict in vivo bone vascularization with an ultra-high-resolution computed tomography (UHR-CT) scanner using a deep learning reconstruction (DLR) and hybrid iterative reconstruction (HIR) algorithms, compared to simulated conventional CT, using osteoid osteoma (OO) as a model.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

October 28, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

December 20, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

1 month

First QC Date

October 28, 2022

Last Update Submit

November 23, 2022

Conditions

Bone Vascular Tumor

Keywords

CTOsteoid OsteomaUltra High Resolution CT

Outcome Measures

Primary Outcomes (2)

  • Number of cortical vessels

    Number

    Retrospective review of all ultra high resolution CT of the precedent 2 years

  • Number of nidus vessels

    Number

    Retrospective review of all ultra high resolution CT of the precedent 2 years

Secondary Outcomes (1)

  • Confidence Score

    Retrospective review of all ultra high resolution CT of the precedent 2 years

Interventions

CTDIAGNOSTIC_TEST

Ultra High Resolution CT scan

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

retrospective inclusion of all histologically proven Osteoid Osteoma referred to our department for CT imaging

You may qualify if:

  • Proven osteoid osteoma
  • Ultra High Resolution CT

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoma, Osteoid

Condition Hierarchy (Ancestors)

OsteomaNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Romain GILLET, MD

CONTACT

0680987216romain_gillet3@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSK Radiologist

Study Record Dates

First Submitted

October 28, 2022

First Posted

November 29, 2022

Study Start

December 20, 2022

Primary Completion

January 31, 2023

Study Completion

March 31, 2023

Last Updated

November 29, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share