Protocol

Thyroid Factor

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According to the results of these trials, the optimal protocol for using rhTSH in thyroid cancer patients is as follows:

• The dose is fixed at a once daily intramuscular injection of 0.9mg of rhTSH for 2 consecutive days.

• A 131I dose of at least 148MBq (4mCi) is administered on the day following the second injection of rhTSH.

• A whole-body scan is performed 48 h after radioiodine administration, with standardized procedures.

• Serum Tg determination is performed 3 days after the second injection of rhTSH. Indeed, sera containing interferences from antithyroglobulin antibody should be excluded from the analysis, and a sensitive IRMA method should be used to measure serum Tg.

• Serum TSH may also be measured, but only to ensure that rhTSH has been injected. If TSH is measured, it should be measured 1 or 3 days after the second rhTSH injection.

• During this procedure, thyroxine treatment is maintained. Urinary iodine excre tion was slightly increased as compared with hypothyroidism, in relation to the iodine content of L-thyroxine, but was always far below 200 |mg, and this increase probably did not affect the iodine uptake after a strong stimulation with rhTSH.

Altogether, these clinical trials have clearly shown that rhTSH is an effective and safe alternative to thyroid hormone withdrawal in the postsurgical diagnostic follow-up of patients with papillary and follicular thyroid cancer. The cost of injections is well balanced with the advantages of its use. These studies confirmed the rationale for the use of rhTSH in clinical practice and showed its potential benefit and possible limitations, paving the way for a large series of subsequent clinical studies.

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