HyperthyroidismTHIDOSNCT06371339
Optimization With a Gamma Camera of the Individualized Patient Dosimetry in Radioiodine Therapy of Thyroid Diseases
A study testing Additional acquisitions with the investigational gamma-camera " MoTI ". in people with Hyperthyroidism, run by Institut Claudius Regaud at 1 site in France.
Trial summary
This is a pilot, single-center, prospective, open-label clinical investigation of a medical device (ambulatory gamma camera " MoTI " (Mobile Therapy Imager)) for patients with hyperthyroidism (Graves' disease, toxic nodule and toxic multiheteronodular goiter) for whom 131I treatment is indicated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperthyroidism
- What is being tested?
- Additional acquisitions with the investigational gamma-camera " MoTI ".
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2024to 27 May 2025
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years.
- Patient with hyperthyroidism (Graves' disease, toxic nodular goiter (TNG) or toxic multi hetero nodular goiter (GMHNT)) relevant to an indication for 131I treatment.
- Patient with no risk of iodine saturation.
- Patient able to maintain a sitting position in an armchair for 10 minutes with chin raised and held by a "chin rest" with head in extension.
- WHO index ≤ 1.
- For non-menopausal patients, use of an effective contraceptive method at the start of the clinical investigation and throughout the clinical investigation, and a negative pregnancy test before administration of the tracer activity and the 131I therapeutic activity.
- Patient signed informed consent prior to inclusion in the clinical investigation and prior to any specific procedure for the clinical investigation.
- Patient affiliated to a social security scheme in France.
Who cannot join
- Absence of clinical or biological hyperthyroidism.
- Patient with a contraindication to 131I treatment.
- Existence of one or more nodule(s) associated with hyperthyroidism at risk of malignancy according to EU-TIRADS and Bethesda criteria if cytopuncture performed.
- Active orbithopathy associated with Graves' disease.
- Contrast-enhanced examination performed within the two months prior to inclusion.
- Use of iodised products for skin disinfection (Betadine) in the 4 weeks prior to inclusion.
Show all 12Show fewer
- Treatment with Amiodarone and derivatives in the 18 months prior to inclusion. (Ioduria test to rule out iodine saturation).
- Pregnant or breast-feeding woman.
- Patient planning pregnancy within 6 months of 131I treatment.
- Any psychological, family, geographical or sociological condition that makes it impossible to comply with the medical monitoring and/or procedures set out in the clinical investigation protocol.
- Any co-existing medical condition which, in the opinion of the investigator, could constitute a risk by participating in this study.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of a Gamma Camera for Optimizing Dosimetry of Patients With Thyroid Disease Treated With Radioactive Iodine
This is a pilot, single-center, prospective, open-label clinical investigation of a medical device (ambulatory gamma camera " MoTI " (Mobile Therapy Imager)) for patients with hyperthyroidism (Graves' disease, toxic nodule and toxic multiheteronodular goiter) for whom 131I treatment is indicated.
Its aim is to assess the feasibility of using this ambulatory gamma camera (MoTI) in the clinic in this patient population.
20 patients will be included in the study.
- Conditions
- Hyperthyroidism
- Being tested
- Additional acquisitions with the investigational gamma-camera " MoTI ".
- Keywords
- Hyperthyroidism, 131I treatment, Thyroid scintigraphy, Gamma camera
- Medical subject headings
- Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional acquisitions with the investigational gamma-camera " MoTI ".Device
The gamma-camera MoTI will be used for the study to carry out 3 or 4 additional acquisitions (depending on the therapeutic indication) compared with those provided for in standard practice with a conventional gamma camera (Syngula).
Patients will receive their treatment as usual in two stages:
- 1/ Pre-therapy phase:
- Administration of a tracer dose of 131I (Day 0).
- Assessment of 131I uptake/fixation rate at Day 0, Day 1, Day 5.
- Determination of the therapeutic dose of 131I to be administered to the patient after collegial discussion.
- 2/ Therapy phase:
- Administration of the therapeutic dose (Day 0).
- Thyroid scintigraphy within 4 hours of treatment before the patient returns home (Day 0).
For the study, scintigraphic acquisitions will be carried out respectively using both the standard gamma camera Syngula and the gamma camera MoTI.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hyperthyroidism treated and monitored according to the standard practices. | Other | Not described Receives: Device: Additional acquisitions with the investigational gamma-camera " MoTI ". |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical feasibility of using an ambulatory gamma camera.
Clinical feasibility will be assessed according to the following dimensions:
- Tolerability and acceptability of the gamma camera by the patient, assessed on a Likert scale between 1 (Not tolerated) and 5 (No discomfort) - (use of a "Patient Evaluation Questionnaire").
- The quality of the images for the expected clinical use, assessed on a Likert scale from 1 (Not interpretable) to 5 (Totally Interpretable).
Success is defined as a patient for whom the tolerability and image production dimensions are >=3 for both examinations (Day 0 and Day 1 of the pre-therapy phase). A failure is defined as a patient presenting with at least one criterion <3 for one of the two examinations.
Measured: Maximum 1 month for each patient.
Secondary outcomes (5)
The level of acceptance of the gamma camera by operators for carrying out examinations
The level will be assessed according to different dimensions: ergonomics, ease of handling, ease of installation, carrying out the examination and processing the examination. For each dimension, a Likert scale between 1 and 5 will be used (using a "Caregiver Evaluation Questionnaire").
Measured: Maximum 1 month for each patient.
The quality of the images for the expected clinical use
The quality will be assessed using a Likert scale from 1 (Not Interpretable) to 5 (Fully Interpretable).
Measured: Maximum 1 month for each patient.
The ability of the gamma camera to generate images compatible with the Picture Archiving and Communication System (PACS)
It will be assessed using a Likert scale of 1 (Totally incompatible) and 5 (Totally compatible).
Measured: Maximum 1 month for each patient.
The quality of the images obtained with the ambulatory gamma camera compared with those obtained during the standard examination (i.e. gamma camera used in the department, Syngula)
The quality will be assessed using a Likert scale between 1 (Not at all satisfactory) and 5 (Very satisfactory).
Measured: Maximum 1 month for each patient.
The 131I fixation rates will be measured in percent at different times.
Measured: Maximum 1 month for each patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start25 Apr 2024
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthyroidismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire IJCLab
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371339
- Sponsor's protocol ID
- 23 VADS 03
- Acronym
- THIDOS
- Status last verified
- Aug 2025
- First submitted
- 5 Apr 2024
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Gamma Camera for Optimizing Dosimetry of Patients With Thyroid Disease Treated With Radioactive Iodine
- ClinicalTrials.gov ID
- NCT06371339
- Acronym / sponsor ID
- THIDOS / 23 VADS 03
- Conditions
- Hyperthyroidism
- Keywords
- Hyperthyroidism, 131I treatment, Thyroid scintigraphy, Gamma camera
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- Laboratoire IJCLab
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 17 Apr 2024 (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.
This is a pilot, single-center, prospective, open-label clinical investigation of a medical device (ambulatory gamma camera " MoTI " (Mobile Therapy Imager)) for patients with hyperthyroidism (Graves' disease, toxic nodule and toxic multiheteronodular goiter) for whom 131I treatment is indicated.
Its aim is to assess the feasibility of using this ambulatory gamma camera (MoTI) in the clinic in this patient population.
20 patients will be included in the study.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hyperthyroidism treated and monitored according to the standard practices. | Other | Device: Additional acquisitions with the investigational gamma-camera " MoTI ". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years.
- Patient with hyperthyroidism (Graves' disease, toxic nodular goiter (TNG) or toxic multi hetero nodular goiter (GMHNT)) relevant to an indication for 131I treatment.
- Patient with no risk of iodine saturation.
- Patient able to maintain a sitting position in an armchair for 10 minutes with chin raised and held by a "chin rest" with head in extension.
- WHO index ≤ 1.
Key exclusion criteria (12 listed)
- Absence of clinical or biological hyperthyroidism.
- Patient with a contraindication to 131I treatment.
- Existence of one or more nodule(s) associated with hyperthyroidism at risk of malignancy according to EU-TIRADS and Bethesda criteria if cytopuncture performed.
- Active orbithopathy associated with Graves' disease.
- Contrast-enhanced examination performed within the two months prior to inclusion.
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 |
|---|---|---|
| Additional acquisitions with the investigational gamma-camera " MoTI ".The gamma-camera MoTI will be used for the study to carry out 3 or 4 additional acquisitions (depending on the therapeutic indication) compared with those provided for in standard practice with a conventional gamma camera (Syngula). Patients will receive their treatment as usual in two stages: * 1/ Pre-therapy phase: 1. Administration of a tracer dose of 131I (Day 0). 2. Assessment of 131I uptake/fixation rate at Day 0, Day 1, Day 5. 3. Determination of the therapeutic dose of 131I to be administered to the patient after collegial discussion. * 2/ Therapy phase: 1. Administration of the therapeutic dose (Day 0). 2. Thyroid scintigraphy within 4 hours of treatment before the patient returns home (Day 0). For the study, scintigraphic acquisitions will be carried out respectively using both the standard gamma camera Syngula and the gamma camera MoTI. | Device | Patients with hyperthyroidism treated and monitored according to the standard practices. |
Primary outcome
The clinical feasibility of using an ambulatory gamma camera.
Time frame: Maximum 1 month for each patient.
Clinical feasibility will be assessed according to the following dimensions: 1. Tolerability and acceptability of the gamma camera by the patient, assessed on a Likert scale between 1 (Not tolerated) and 5 (No discomfort) - (use of a "Patient Evaluation Questionnaire"). 2. The quality of the images for the expected clinical use, assessed on a Likert scale from 1 (Not interpretable) to 5 (Totally Interpretable). Success is defined as a patient for whom the tolerability and image production dimensions are >=3 for both examinations (Day 0 and Day 1 of the pre-therapy phase). A failure is defined as a patient presenting with at least one criterion <3 for one of the two examinations.
5 secondary outcomes
The level of acceptance of the gamma camera by operators for carrying out examinations
Time frame: Maximum 1 month for each patient.
The quality of the images for the expected clinical use
Time frame: Maximum 1 month for each patient.
The ability of the gamma camera to generate images compatible with the Picture Archiving and Communication System (PACS)
Time frame: Maximum 1 month for each patient.
The quality of the images obtained with the ambulatory gamma camera compared with those obtained during the standard examination (i.e. gamma camera used in the department, Syngula)
Time frame: Maximum 1 month for each patient.
The 131I fixation rates will be measured in percent at different times.
Time frame: Maximum 1 month for each patient.
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 6 Aug 2025.
Related trials for Hyperthyroidism
RecruitingPhase 2
Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease
Graves' Disease
RecruitingPhase 1
NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease
Graves Disease
RecruitingPhase 2
A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old
Graves' Disease
Not yet recruitingPhase 2/3
An Open-Label Study to Determine if BHV-1300 is Safe in Adults With Graves' Disease
Graves' Disease
RecruitingPhase 1
Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease
Thyroid Eye Disease (TED), Graves' Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional acquisitions with the investigational gamma-camera " MoTI ". in people with Hyperthyroidism, run by Institut Claudius Regaud at 1 site 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 8 inclusion and 12 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 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The clinical feasibility of using an ambulatory gamma camera. (time frame: Maximum 1 month for each patient.). 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 6 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.