Scintigraphy QuantificationQUANTOSS-3DNCT04671238
Absolute Quantification in Bone Scintigraphy
An observational study of Scintigraphy Quantification, run by Central Hospital, Nancy, France at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scintigraphy Quantification
- What is being tested?
- SPECT CT
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Jan 2020to 1 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for SPECT/CT scan of the spine as part of a vertebroplasty workup and selected retrospectively.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Nancy - Hôpital Brabois
Vandœuvre-lès-Nancy, 54500
Chru Nancy
Vandœuvre-lès-Nancy, 54511
CHRU of Nancy
Vandœuvre-lès-Nancy, 54511
About this study
Official title: 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).
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.
- Conditions
- Scintigraphy Quantification
- Being tested
- SPECT CT
- Keywords
- bone scintigraphy, absolute quantification, Standard Uptake Value
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT CTDevice
SPECT/CT scan of the spine as part of a vertebroplasty
| Study group | Role | What they receive |
|---|---|---|
| Patient for SPECT/CT scan | Patients referred for SPECT/CT scan of the spine as part of a vertebroplasty workup and selected retrospectively. Receives: Device: SPECT CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 1 year
Secondary outcomes (3)
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
Measured: 1 day
To evaluate the attenuation correction on phantoms of different density
SUV absolute quantitation index (SUVmax, SUVpeak, SUVmean).
Measured: 1 day
To evaluate absolute quantification on phantoms
Evaluate absolute quantification on phantoms with objects of different volumes
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jan 2020
- Primary completion1 Nov 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scintigraphy QuantificationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Yves MARIE, Central Hospital, Nancy, France
- Investigators
- BALHOUL Achraf, MD, Principal investigator, CHRU of Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671238
- Sponsor's protocol ID
- 2020PI241
- Acronym
- QUANTOSS-3D
- Status last verified
- Sep 2022
- First submitted
- 13 Nov 2020
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absolute Quantification in Bone Scintigraphy: Phantom Evaluation and Clinical Application in Patients Undergoing Follow-up for Vertebral Fractures.
- ClinicalTrials.gov ID
- NCT04671238
- Acronym / sponsor ID
- QUANTOSS-3D / 2020PI241
- Conditions
- Scintigraphy Quantification
- Keywords
- bone scintigraphy, absolute quantification, Standard Uptake Value
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient for SPECT/CT scan | – | Device: SPECT CTPatients referred for SPECT/CT scan of the spine as part of a vertebroplasty workup and selected retrospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for SPECT/CT scan of the spine as part of a vertebroplasty workup and selected retrospectively.
Key inclusion criteria (3 listed)
- Patients with recent vertebral fractures:
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPECT CTSPECT/CT scan of the spine as part of a vertebroplasty | Device | Patient for SPECT/CT scan |
Primary outcome
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
3 secondary outcomes
To calibrate the tomographic images from the gamma camera
Time frame: 1 day
To evaluate the attenuation correction on phantoms of different density
Time frame: 1 day
To evaluate absolute quantification on phantoms
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Scintigraphy Quantification
Recruiting
SPECT/CT Bone Scan Quantification Surgery
Pseudoarthrosis of Bone
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BALHOUL Achraf, MD principal investigator
CHRU of Nancy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scintigraphy Quantification, run by Central Hospital, Nancy, France at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate the absolute bone scan quantification in a retrospectively selected patient population (time frame: After 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.