|- candidate number||8189|
|- NTR Number||NTR2395|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-jun-2010|
|- Secondary IDs||METC 2009/199 UMC Groningen|
|- Public Title||Ablation therapy in differentiated thyroid cancer with recombinant TSH.|
|- Scientific Title||I-131 remnant ablation in differentiated thyroid cancer - Optimal treatment with maximal outcome.|
|- ACRONYM||Links I 131 ablation|
|- Healt Condition(s) or Problem(s) studied||Differentiated thyroid carcinoma, Ablation therapy, Recombinant TSH, Thyroid hormone withdrawal|
|- Inclusion criteria||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.
|- Exclusion criteria||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).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||15-jun-2010|
|- planned closingdate||1-jan-2014|
|- Target number of participants||144|
|- Interventions||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).
|- Primary outcome||Successful ablation defined as: rhTSH Tg<1ng/ml, negative rhTSH dx WBS, negative US and negative Tg antibodies.|
|- Secondary outcome||N/A|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr. T.P. Links|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. T.P. Links|
|- Sponsor/Initiator ||University Medical Centre Groningen (UMCG), Department of Endocrinology|
(Source(s) of Monetary or Material Support)
|- Brief summary||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.|
|- Main changes (audit trail)|
|- RECORD||29-jun-2010 - 26-jul-2010|