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Ablation therapy in differentiated thyroid cancer with recombinant TSH.

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23578
Enrollment
144
Registered
2010-06-29
Start date
2010-06-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gedifferentieerd schildkliercarcinoom differentiated thyroid cancer ablation therapy ablatie therapie recombinant TSH thyroid hormone withdrawal schildklierhormoon onttrekking I-131 therapie

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

Sponsors

Prof.dr. T.P. Links, endocrinologist
Lead Sponsor

Eligibility

Inclusion criteria

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 40ml/min); 6. No iodine containing medication or recent history of iodine containing imaging contrast agents; 7. Male and female.

Exclusion criteria

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).

Design outcomes

Primary

MeasureTime frame
Successful ablation defined as: rhTSH Tg<1ng/ml, negative rhTSH dx WBS, negative US and negative Tg antibodies.

Contacts

Public ContactT.P. Links

Hanzeplein 1

+31 (0)50 3613744

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)