An interventional study of Additional acquisitions with the investigational gamma-camera " MoTI ". in Hyperthyroidism, sponsored by Institut Claudius Regaud. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-06.
Sponsored by Institut Claudius Regaud · Not applicable, Interventional, and Device feasibility
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.
112 studies on the registry are indexed under Hyperthyroidism; 27 are open to participants now.
This study's enrollment of 22 is below the median of 60 across 61 interventional studies indexed under Hyperthyroidism.
Browse Hyperthyroidism studies →Institut Claudius Regaud is the lead sponsor of 117 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: 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.
The clinical feasibility of using an ambulatory gamma camera.
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.
Time frame: Maximum 1 month for each patient.
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").
Time frame: 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).
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)
It will be assessed using a Likert scale of 1 (Totally incompatible) and 5 (Totally compatible).
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)
The quality will be assessed using a Likert scale between 1 (Not at all satisfactory) and 5 (Very satisfactory).
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.
Ran from Apr 2024 to primary completion in May 2025, 13 months.
Of 15 interventional studies with no phase under Hyperthyroidism, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 46. This study's 13 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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