Trials / Unknown
UnknownNCT05628506
Measurement of Iodolipids in the Thyroid Gland and Other Biological Samples
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Prof. Gerasimos Sykiotis · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The research project is an open, parallel-group, single centre, randomized controlled trial that aims to assess the feasibility of measuring iodolipids in thyroid samples of patients during routine thyroid surgery.
Detailed description
Twenty subjects will be included. Patients are randomized 1:1 to receive either a single oral administration of a pharmacological dose of potassium iodide 20±4 hours before surgery (10 patients), or nothing (10 patients): * The dose administered will be 97.5 mg, * Patients allocated to the control group will not receive any drug. Two thyroid samples will be taken from the surgical specimen by a pathologist. Each sample will have a weight of approximatively 1 g, corresponding to a volume of approximately 1 cm3. We will select material containing tissue that corresponds to normal thyroid parenchyma (according to the preoperative ultrasound and direct inspection by the pathologist intraoperatively). The sample will be taken in the dedicated room next to the operating room by a pathologist who will confirm that the targeted area has no visible macroscopic lesion. In case of doubt, an alternative area free of lesion will be selected by the pathologist. Patients are unblinded. The total maximum duration of the study for an individual patient is 42 days. The total duration of the clinical trial will be 3 years in order to include 20 patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Potassium iodide | Patients will receive a single oral administration of a pharmacological dose (97.5 mg) of potassium iodide 20±4 hours before surgery. |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2025-12-31
- Completion
- 2026-02-11
- First posted
- 2022-11-28
- Last updated
- 2022-11-28
Source: ClinicalTrials.gov record NCT05628506. Inclusion in this directory is not an endorsement.