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| Name | Class |
|---|---|
| Laboratoire IJCLab | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with hyperthyroidism treated and monitored according to the standard practices. | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
For the study, scintigraphic acquisitions will be carried out respectively using both the standard gamma camera Syngula and the gamma camera MoTI. |
| Measure | Description | Time Frame |
|---|---|---|
| The clinical feasibility of using an ambulatory gamma camera. | 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. | Maximum 1 month for each patient. |
| Measure | Description | Time Frame |
|---|---|---|
| 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"). | Maximum 1 month for each patient. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IUCT-O | Toulouse | France |
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| ID | Term |
|---|---|
| D006980 | Hyperthyroidism |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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| 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). | 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). | 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). | Maximum 1 month for each patient. |
| The 131I fixation rates will be measured in percent at different times. | Maximum 1 month for each patient. |