Absolute Quantification in Bone Scintigraphy (QUANTOSS-3D)

September 8, 2022 updated by: Pierre Yves MARIE, Central Hospital, Nancy, France

Absolute Quantification in Bone Scintigraphy: Phantom Evaluation and Clinical Application in Patients Undergoing Follow-up for Vertebral Fractures.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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:

  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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
SPECT/CT scan of the spine as part of a vertebroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To validate the absolute bone scan quantification in a retrospectively selected patient population
Time Frame: After 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To calibrate the tomographic images from the gamma camera
Time Frame: 1 day
Calibrate the tomographic images from the gamma camera to obtain a volume activity in Bq/mLand densities
1 day
To evaluate the attenuation correction on phantoms of different density
Time Frame: 1 day
SUV absolute quantitation index (SUVmax, SUVpeak, SUVmean).
1 day
To evaluate absolute quantification on phantoms
Time Frame: 1 day
Evaluate absolute quantification on phantoms with objects of different volumes
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: BALHOUL Achraf, MD, CHRU of Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

November 13, 2020

First Submitted That Met QC Criteria

December 11, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 8, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020PI241

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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