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van CCT (UK)

van CCT (UK)

Ablation therapy in differentiated thyroid cancer with recombinant TSH.

- candidate number8189
- NTR NumberNTR2395
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-jun-2010
- Secondary IDsMETC 2009/199 UMC Groningen
- Public TitleAblation therapy in differentiated thyroid cancer with recombinant TSH.
- Scientific TitleI-131 remnant ablation in differentiated thyroid cancer - Optimal treatment with maximal outcome.
- ACRONYMLinks I 131 ablation
- hypothesis
- Healt Condition(s) or Problem(s) studiedDifferentiated thyroid carcinoma, Ablation therapy, Recombinant TSH, Thyroid hormone withdrawal
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-jun-2010
- planned closingdate1-jan-2014
- Target number of participants144
- InterventionsStudy 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 g/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 outcomeSuccessful ablation defined as: rhTSH Tg<1ng/ml, negative rhTSH dx WBS, negative US and negative Tg antibodies.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator University Medical Centre Groningen (UMCG), Department of Endocrinology
- Funding
(Source(s) of Monetary or Material Support)
Genzyme Corporation
- PublicationsN/A
- Brief summaryThis 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)
- RECORD29-jun-2010 - 26-jul-2010

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