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CompletedNCT04671238QUANTOSS-3DUpdated Sep 13, 2022

Absolute Quantification in Bone Scintigraphy

An observational study in Scintigraphy Quantification, sponsored by Central Hospital, Nancy, France. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-13.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
21
Ages
18 Years and older
Sex
All
01

Study 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).

Read the detailed description

In oncology, bone scan studies have reported significantly higher SUV values for secondary bone lesions compared with benign osteoarticular lesions , and some have even defined an SUVmax threshold value that points to prostatic bone metastases.

02

Conditions studied

  • Scintigraphy Quantification

Keywords

  • bone scintigraphy
  • absolute quantification
  • Standard Uptake Value
03

In context

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 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

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

Inclusion criteria

  • Patients with recent vertebral fractures:

    1. who have had at least two SPECT/CT scan scans of the spine as part of a pre-vertebroplasty check-up,
    2. for which fracture dates were known.

Exclusion criteria

Exclusion Criteria:

  1. Minor person
  2. 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)
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
21 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceSPECT CT

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

06

What researchers measure

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

    Time frame: After 1 year

Secondary outcomes

  1. To calibrate the tomographic images from the gamma camera

    Calibrate the tomographic images from the gamma camera to obtain a volume activity in Bq/mLand densities

    Time frame: 1 day

  2. To evaluate the attenuation correction on phantoms of different density

    SUV absolute quantitation index (SUVmax, SUVpeak, SUVmean).

    Time frame: 1 day

  3. To evaluate absolute quantification on phantoms

    Evaluate absolute quantification on phantoms with objects of different volumes

    Time frame: 1 day

07

Study locations

3 sites
  • CHU de Nancy - Hôpital Brabois
    Vandoeuvre-Lès-Nancy, 54500, France
  • Chru Nancy
    Vandœuvre-lès-Nancy, 54511, France
  • CHRU of Nancy
    Vandœuvre-lès-Nancy, 54511, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2022, 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
NCT04671238
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Pierre Yves MARIE (Study director, Central Hospital, Nancy, France) — Principal investigator
First posted
Dec 17, 2020
Start date
Jan 1, 2020
Primary completion
Nov 1, 2020
Completion
Feb 1, 2021
Last update
Sep 13, 2022

Study contacts

BALHOUL Achraf, MD
principal investigator · CHRU of Nancy

Oversight

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

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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