Efficacy in Diagnostic Testing

Efficacy Results in Diagnostic Testing

Allow patients to remain euthyroid in diagnostic follow up using stimulated Tg Testing with or without a Whole-Body Scan

Comparing Thyrogen with THW in Tg Testing

Study Design

  • In a prospective, randomized, phase 3 clinical trial with a cross-over, nonblinded design, 229 patients with well-differentiated thyroid cancer who had undergone total or near-total thyroidectomy were studied to compare whole body scans. Each patient was scanned first using THYROGEN, then scanned using thyroid hormone withdrawal. Tg levels were compared after Thyrogen to those at baseline and to those after thyroid hormone withdrawal (THW)3
  • Patients who were included in the Tg analysis were those who had undergone total or near-total thyroidectomy with or without 131-I ablation, had < 1% uptake in the thyroid bed on a scan after thyroid hormone withdrawal, and did not have detectable anti-Tg antibodies.
  • The maximum Thyrogen Tg value was obtained 72 hours after the final Thyrogen injection, and this value was used in the analysis.1

Stimulated Tg versus non stimulated Tg testing

Approximately 1 in 5 metastatic disease positives were missed with non stimulated Tg testing1

Among patients with metastatic disease confirmed by a post treatment scan or by lymph node biopsy (35 patients), Thyrogen Tg was positive (≥2.5 ng/mL) in all 35 patients, while Tg on thyroid hormone suppressive therapy was positive (>2.5 ng/mL) in 79% of these patients.1

As with THW, the intrapatient reproducibility of Thyrogen testing with regard to both Tg stimulation and radio iodine imaging has not been studied.

Uptake comparable in whole body scan (WBS)

Study Design

  • Two prospective, randomized, phase clinical trials with a cross-over, nonblinded design, were conducted in patients with well differentiated thyroid cancer to compare 131-I WBS’s obtained after Thyrogen injection to 131-I WBS’s after THW. In both studies, the primary endpoint was the rate of comparable scan.1
  • Across the two clinical studies the majority of positive scans using Thyrogen and THW were comparable.1
  • The use of Thyrogen in preparation for WBS was comparable to THW in both efficacy and safety for stimulating the uptake of radioactive iodine (RAI).3
  • Patients with residual thyroid tissue at risk for Thyrogen-induced hyperthyroidism include the elderly and those with a known history of heart disease.

WBS Image2

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