Thyroid DiseasesGAMMA-CAMNCT03414021
Interest of the SPECT-CT Scan SUVspect in the New Generation of Gamma-cameras With Semiconductor
An observational study of Thyroid Diseases and Heart Diseases, run by Lille Catholic University at 2 sites in France.
Trial summary
Since 2017, a revolution began in the departments of nuclear medicine, with the routine use of gamma-cameras with semiconductor. These gamma-cameras (which obtained the CE-marking in 2016), offer a technological breakthrough by providing an additional information. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Diseases, Heart Diseases, Bone Diseases
- What is being tested?
- SPECT-CT Scan
- Type of treatment
- Injection or infusion
- How many people
- 250 participants
- Where
- 2 sitesFrance
- Study dates
- 31 Jan 2018to 30 Dec 2025
- 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: Every patient referred to our departments of nuclear medicine for a nuclear médicine exploration
Who may be able to join
- informed adult patients referred to our department of nuclear medicine for a nuclear medicine exploration
Who cannot join
- Refusal to participate
- Patient under guardianship
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Not yet recruiting
Hopital Privé Le Bois
Lille, Hauts-de-France, 59000
Tanguy Blaire, MD, PhD, 03.20.09.92.92 ext. +33
Tanguy Blaire, MD, PhD
- Recruiting
Humanitep
Lomme, Hauts-de-France, 59462
Tanguy Blaire, MD, PhD, 03.20.00.24.14 ext. +33
Tanguy Blaire, MD, PhD
About this study
Official title: Quantification in Nuclear Medicine: Interest of the in SPECT-CT Scan SUVspect in Thea New Generation of Gamma-cameras With Semiconductor. Data Collection for the Constitution of an Observatory of Scintigraphies
Since 2017, a revolution began in the departments of nuclear medicine, with the routine use of gamma-cameras with semiconductor. These gamma-cameras (which obtained the CE-marking in 2016), offer a technological breakthrough by providing an additional information. They allow "to quantify" for the 1st time in clinical routine conditions, the quantity of radioactivity, by means of a "SUVspect", in a volume of interest, while respecting the recommendations of best practice of the learned societies of French nuclear medicine (SFMN), European (EANM) and American (SNM), without injection of tracer nor acquisition or additional irradiation. The SUVspect is therefore an indicator of the quantity of tracer in a given volume of acquisition.
Until now, the interpretation criteria of scintigraphies are based on the homogeneity of distribution of a tracer in the explored organ (for single organs such as the heart or the thyroid, for example) or in the asymmetry of distribution of the tracer (for the double organs, such as the kidney or the joints).
Read more
This new gamma-camera allows to study the distribution of the radio-tracers in "list" mode, allowing to retrospectively reconstruct the images in various ways (for example, by modifying the size of the matrix of acquisition, the energy windows, the time of acquisition). Therefore, we can simulate and propose modifications in current procedures.
Every patient referred to our department of nuclear medicine to undergo a scintigraphy with a tracer of nuclear medicine (with a marketing authorization) can, while benefiting from an examination by this gamma-camera, to be the object of this study, and to profit from this additional information.
So, without changing the diagnosis or the usual care, we wish to take advantage of this additional information to improve the criteria of interpretation of our examinations.
This possibility being new, there is no available bibliography (our department is the 5th department of nuclear medicine in Europe to equip itself with this large field-of-view gamma-camera CZT, the DNM 670, made by General Electric), while 2961 articles speak about the SUVmax (in PET) in Pubmed.
- Conditions
- Thyroid Diseases, Heart Diseases, Bone Diseases, Brain Diseases, Kidney Diseases
- Being tested
- SPECT-CT Scan
- Keywords
- Nuclear Medicine, SPECT-CT Scan, gamma-camera with semiconductor
- Medical subject headings
- Thyroid Diseases, Heart Diseases, Bone Diseases, Brain Diseases, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT-CT ScanDiagnostic test
Injection of a Tracer and SPECT-CT Scan
| Study group | Role | What they receive |
|---|---|---|
| Thyroid Diseases | SPECT-CT Scan Receives: Diagnostic Test: SPECT-CT Scan | |
| Heart Diseases | SPECT-CT Scan Receives: Diagnostic Test: SPECT-CT Scan | |
| Bone Diseases | SPECT-CT Scan Receives: Diagnostic Test: SPECT-CT Scan | |
| Brain Diseases | SPECT-CT Scan Receives: Diagnostic Test: SPECT-CT Scan | |
| Kidney Diseases | SPECT-CT Scan Receives: Diagnostic Test: SPECT-CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVspect
Pathological threshold (SUVspect) for every type of scintigraphy
Measured: 5 years
Secondary outcomes (2)
Matrix size
Optimize the reconstruction parameters of the images
Measured: 5 years
duration of image acquisition
Optimize the reconstruction parameters of the images
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start31 Jan 2018
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseasesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanguy Blaire, MD, Principal investigator, GIE HUMANITEP, GHICLAlban Baillez, MD, Principal investigator, GIE HUMANITEP, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414021
- Sponsor's protocol ID
- OBS-0030
- Acronym
- GAMMA-CAM
- Status last verified
- Mar 2024
- First submitted
- 23 Jan 2018
- Last updated
- 26 Mar 2024
- 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 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification in Nuclear Medicine: Interest of the in SPECT-CT Scan SUVspect in Thea New Generation of Gamma-cameras With Semiconductor. Data Collection for the Constitution of an Observatory of Scintigraphies
- ClinicalTrials.gov ID
- NCT03414021
- Acronym / sponsor ID
- GAMMA-CAM / OBS-0030
- Conditions
- Thyroid Diseases, Heart Diseases, Bone Diseases, Brain Diseases, Kidney Diseases
- Keywords
- Nuclear Medicine, SPECT-CT Scan, gamma-camera with semiconductor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 29 Jan 2018 (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.
Since 2017, a revolution began in the departments of nuclear medicine, with the routine use of gamma-cameras with semiconductor. These gamma-cameras (which obtained the CE-marking in 2016), offer a technological breakthrough by providing an additional information. They allow "to quantify" for the 1st time in clinical routine conditions, the quantity of radioactivity, by means of a "SUVspect", in a volume of interest, while respecting the recommendations of best practice of the learned societies of French nuclear medicine (SFMN), European (EANM) and American (SNM), without injection of tracer nor acquisition or additional irradiation. The SUVspect is therefore an indicator of the quantity of tracer in a given volume of acquisition.
Until now, the interpretation criteria of scintigraphies are based on the homogeneity of distribution of a tracer in the explored organ (for single organs such as the heart or the thyroid, for example) or in the asymmetry of distribution of the tracer (for the double organs, such as the kidney or the joints).
This new gamma-camera allows to study the distribution of the radio-tracers in "list" mode, allowing to retrospectively reconstruct the images in various ways (for example, by modifying the size of the matrix of acquisition, the energy windows, the time of acquisition). Therefore, we can simulate and propose modifications in current procedures.
Every patient referred to our department of nuclear medicine to undergo a scintigraphy with a tracer of nuclear medicine (with a marketing authorization) can, while benefiting from an examination by this gamma-camera, to be the object of this study, and to profit from this additional information.
So, without changing the diagnosis or the usual care, we wish to take advantage of this additional information to improve the criteria of interpretation of our examinations.
This possibility being new, there is no available bibliography (our department is the 5th department of nuclear medicine in Europe to equip itself with this large field-of-view gamma-camera CZT, the DNM 670, made by General Electric), while 2961 articles speak about the SUVmax (in PET) in Pubmed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Thyroid Diseases | – | Diagnostic Test: SPECT-CT ScanSPECT-CT Scan |
| Heart Diseases | – | Diagnostic Test: SPECT-CT ScanSPECT-CT Scan |
| Bone Diseases | – | Diagnostic Test: SPECT-CT ScanSPECT-CT Scan |
| Brain Diseases | – | Diagnostic Test: SPECT-CT ScanSPECT-CT Scan |
| Kidney Diseases | – | Diagnostic Test: SPECT-CT ScanSPECT-CT Scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient referred to our departments of nuclear medicine for a nuclear médicine exploration
Key inclusion criteria (1 listed)
- informed adult patients referred to our department of nuclear medicine for a nuclear medicine exploration
Key exclusion criteria (2 listed)
- Refusal to participate
- Patient under guardianship
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-CT ScanInjection of a Tracer and SPECT-CT Scan | Diagnostic test | Bone Diseases, Brain Diseases, Heart Diseases, Kidney Diseases, Thyroid Diseases |
Primary outcome
SUVspect
Time frame: 5 years
Pathological threshold (SUVspect) for every type of scintigraphy
2 secondary outcomes
Matrix size
Time frame: 5 years
duration of image acquisition
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Tanguy Blaire, MD principal investigator
GIE HUMANITEP, GHICL
Alban Baillez, MD principal investigator
GIE HUMANITEP, GHICL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Diseases and Heart Diseases, run by Lille Catholic University at 2 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 1 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: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Paule Lebitasy, MD (03 20 22 57 41 ext. +33, Lebitasy.Marie-Paule@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVspect (time frame: 5 years). 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 26 Mar 2024.