The uptake of radioactive iodine before and after a low iodine diet in patients with differentiated thyroid carcinoma
- Conditions
- differentiated thyroid carcinoma (DTC)thyroid cancer1004373910014713
- Registration Number
- NL-OMON52405
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
- Patients, men and women above the age of 18 years, have to be diagnosed with
DTC and have to follow a LID prior to the 131I therapy according to the Dutch
DTC guideline
- Patients have to be fit to adhere to the study protocol
- Patients have to be able to read and understand the Dutch language
- Age < 18 years
- Patients using amiodarone
- Patients receiving iodinated contrast < 3 months before the LID
- Pregnancy
- Patients prepared for ablation therapy with rhTSH
- R
enal impairment, EGFR <30ml/min/1,73m2
For the substudy, additional exclusion criteria are*:
- History of Sjogren*s disease, or other disease affecting the salivary gland
* If patients meet the exclusion criteria of the substudy, but not those of the
regular study, they are still asked to participate in the regular study.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameter/endpoint<br /><br>The primary endpoint is the clinical relevant difference of a twofold uptake<br /><br>increase, in the thyroid remnant after thyroidectomy in DTC patients, of 10 MBq<br /><br>123I tracer dose before and after a LID of 7 days.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters/endpoints<br />- Compliance to the LID will be evaluated by measuring the UIE before and after<br />the LID.<br />- Clinical cut-off values of SIE for sufficient, insufficient and, deficient,<br />iodine status will be determined based on UIE.</p>