NCT04671238

Brief Summary

While absolute quantification in 18F-FDG PET (Positon Emission Tomography) is widely used in clinical routine, absolute quantification in SPECT (Single Photon Emission Computed Tomography) is under development and its clinical interest remains to be demonstrated. Recent studies carried out on bone scan recordings show the potential interest of quantification indexes such as SUV (Standard Uptake Value).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

3 active sites

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

January 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

November 13, 2020

Last Update Submit

September 8, 2022

Conditions

Keywords

bone scintigraphyabsolute quantificationStandard Uptake Value

Outcome Measures

Primary Outcomes (1)

  • To validate the absolute bone scan quantification in a retrospectively selected patient population

    Analysis of SUV variation on at least 2 bone scans: Variation of the SUV over time on scans of patients with spinal fractures

    After 1 year

Secondary Outcomes (3)

  • To calibrate the tomographic images from the gamma camera

    1 day

  • To evaluate the attenuation correction on phantoms of different density

    1 day

  • To evaluate absolute quantification on phantoms

    1 day

Study Arms (1)

Patient for SPECT/CT scan

Patients referred for SPECT/CT scan of the spine as part of a vertebroplasty workup and selected retrospectively.

Device: SPECT CT

Interventions

SPECT CTDEVICE

SPECT/CT scan of the spine as part of a vertebroplasty

Patient for SPECT/CT scan

Eligibility Criteria

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

Patients referred for SPECT/CT scan of the spine as part of a vertebroplasty workup and selected retrospectively.

You may qualify if:

  • Patients with recent vertebral fractures:
  • who have had at least two SPECT/CT scan scans of the spine as part of a pre-vertebroplasty check-up,
  • for which fracture dates were known.

You may not qualify if:

  • Minor person
  • Person opposing the use of their data (Posters in waiting rooms explaining that the patient must object if they do not wish their data to be used)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU de Nancy - Hôpital Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

Chru Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

CHRU of Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Interventions

Single Photon Emission Computed Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed, Single-PhotonTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • BALHOUL Achraf, MD

    CHRU of Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study director

Study Record Dates

First Submitted

November 13, 2020

First Posted

December 17, 2020

Study Start

January 1, 2020

Primary Completion

November 1, 2020

Study Completion

February 1, 2021

Last Updated

September 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations