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I-131 remnant ablation in differentiated thyroid cancer-optimal treatment with maximal outcome

Withdrawn
Conditions
differentiated thyroid carcinoma
thyroid cancer
10043739
Registration Number
NL-OMON36661
Lead Sponsor
niversitair Medisch Centrum Groningen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
144
Inclusion Criteria

low and high risk patients (AJCC 6) with recently diagnosed histological proven differentiated thyroid cancer, who have to be treated with ablation therapy
aged 18 years or older
not pregnant
not major concurrent diseases (such as stable cardiovascular disease, concurrent malignancy treated < 5 years) leading to a reduced survival < 1 year
normal renal function

Exclusion Criteria

Stage T4
Stage M1 when known before ablation

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary endpoint of successful ablation is defined as: rhTSH Tg<1ng/ml,<br /><br>negative rhTSH dx WBS, negative neck US and negative Tg antibodies.<br /><br><br /><br>In case of TgAb or Tg < 1 ng/ml at tthe time of ablation, a second high dose of<br /><br>I131 will be given according to the Dutch guidelines. In these patients a<br /><br>succesfull ablation will be defined as a post treatment scintigraphy with no<br /><br>visible uptake in the original thyroid bed</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>not applicable</p><br>
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