To determine that rhTSH pretretament during euthyroidism ( already available in an number of centra in the Netherlands) in a adequately powered study is as good as the classical way of inducing hypothyrodism by withholding suppletion which induces…
ID
Source
Brief title
Condition
- Thyroid gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of successful ablation is defined as: rhTSH Tg<1ng/ml,
negative rhTSH dx WBS, negative neck US and negative Tg antibodies.
In case of TgAb or Tg < 1 ng/ml at tthe time of ablation, a second high dose of
I131 will be given according to the Dutch guidelines. In these patients a
succesfull ablation will be defined as a post treatment scintigraphy with no
visible uptake in the original thyroid bed
Secondary outcome
not applicable
Background summary
Patients with differentiated thyroid cancer (papillary and follicular) are
treated with near-total thyroidectomy. in most of the patients this treatment
has to be followed by ablation with I-131 to eliminate remnant thyroid tissue
to decrease the risk of tumor recurrence and improve sensitivity and
specificity of thyroglobulin measurement in follow-up.
Study objective
To determine that rhTSH pretretament during euthyroidism ( already available in
an number of centra in the Netherlands)
in a adequately powered study is as good as the classical way of inducing
hypothyrodism by withholding suppletion which induces endogeneous rise of the
TSH level.
Study design
Prospective observational study design, to evaluate an international accepted
but not in all treating centers applicated therapy.
Intervention
Two rhTSH injections will be given 6 weeks after total thyroidectomy (before
131-I treatment) and 9 months after the first high dose 131-I treatment.
Study burden and risks
After thyroidectomy immediately start with suppletion
After 4 weeks on 2 days in succession 1 injection with rhTSH
After 9 months on 2 days in succession 1 injection with rhTSH
Hanzeplein 1
9713 GZ Groningen
NL
Hanzeplein 1
9713 GZ Groningen
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28778.042.09 |