IUCT-O
Toulouse, France
NCT Number: NCT06371339
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Toulouse, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
For the study, scintigraphic acquisitions will be carried out respectively using both the standard gamma camera Syngula and the gamma camera MoTI.
Time frame: Maximum 1 month for each patient.
Clinical feasibility will be assessed according to the following dimensions:
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 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 will be assessed using a Likert scale from 1 (Not Interpretable) to 5 (Fully Interpretable).
Time frame: Maximum 1 month for each patient.
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 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.
Institut Claudius Regaud
Other
Feasibility Study of a Gamma Camera for Optimizing Dosimetry of Patients With Thyroid Disease Treated With Radioactive Iodine
Acronym: THIDOS
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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.
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