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Completed

NCT Number: NCT04671238

Absolute Quantification in Bone Scintigraphy

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU of Nancy, Vandœuvre-lès-Nancy, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

SPECT CT

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

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

    Time frame: 1 day

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

  3. To evaluate absolute quantification on phantoms

    Time frame: 1 day

    Evaluate absolute quantification on phantoms with objects of different volumes

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: QUANTOSS-3D

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Dec 17, 2020
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.