ID
Bron
Verkorte titel
Aandoening
gedifferentieerd schildkliercarcinoom
differentiated thyroid cancer
ablation therapy
ablatie therapie
recombinant TSH
thyroid hormone withdrawal
schildklierhormoon onttrekking
I-131 therapie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Successful ablation defined as: rhTSH Tg<1ng/ml, negative rhTSH dx WBS, negative US and negative Tg antibodies.
Achtergrond van het onderzoek
This study is determing the rate of ablation failure in differentiated thyroid cancer patients using rhTSH instead of thyroid hormone withdrawal for stimulation of remnant tissue, using a fixed dosage of 3.7 GBq inT1b-T3 N0N1M0 patients.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Study procedures:
After total thyroidectomy and histological confirmation of differentiated thyroid cancer substitution therapy is started (levothyroxine) to reach a TSH level < 0.3 mU/l.
3-6 WEEKS post surgery:
Neck ultrasound (standard application) to confirm the absence of significant thyroid remnant and to screen for lymph nodes. Basal TSH and Tg measurement.
6 WEEKS post surgery:
0.9 mg rhTSH will be administered i.m. at 0 and 24 hours.
At 48 hours 3.7 GBq (100 mCi) I-131 will be administered.
Post treatment scan 7 - 10 days after I-131 application. TSH and Tg measurement at 48 hours. To ensure the I-deficient diet (according to the Dutch guidelines), the iodine excretion in a 24 hours urine will be measured (in µg/l,).
6 MONTHS post ablation therapy:
Neck ultrasound and FNA of suspected nodules (if positive consider re-surgery).
9 MONTHS post ablation therapy:
0.9 mg rhTSH will be administered i.m. at 0 and 24 hours (Monday and Tuesday). At 48 hrs 150 MBq (4 mCi) I-131 application (Wednesday). TSH and Tg measurement and WBS 72 hours (Friday) after administration of 150 MBq (4 mCi) I-131 (i.e. 120 hours after the first rhTSH). (In case of visible uptake on a planar view, then a SPECT view will be made if available).
Publiek
T.P. Links
Groningen 9713 GZ
The Netherlands
+31 (0)50 3613744
Wetenschappelijk
T.P. Links
Groningen 9713 GZ
The Netherlands
+31 (0)50 3613744
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Low and high risk patients (according American Joint Committee on Cancer, AJCC 6) with recently diagnosed histological proven DTC, who have to be treated with ablation therapy. TNM stages T1>1cm, T2, T3, N0, N1, M0 are to be included;
2. Aged 18 years or older;
3. Not pregnant;
4. No major concurrent diseases (such as instable cardiovascular disease, concurrent malignancy treated <5 years);
5. Normal renal function (serum creatinine level <130 umol/l or clearance > 40ml/min);
6. No iodine containing medication or recent history of iodine containing imaging contrast agents;
7. Male and female.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Stage T4;
2. Stage M1 when known before ablation;
3. Stage M1 known after ablation (remove from sequential analysis);
4. Tg antibodies positive at diagnosis;
5. Undetectable Tg during rhTSH stimulation at the time of ablation therapy (remove from sequential analysis).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL2269 |
NTR-old | NTR2395 |
Ander register | UMC Groningen : METC 2009/199 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |