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Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Radioiodine Uptake and Thyroglobulin-Guided Radioiodine Remnant Ablation in Patients with Differentiated Thyroid Cancer: A Prospective, Randomized, Open-Label, Controlled Trial.
BACKGROUND: Radioiodine (131 I) remnant ablation (RRA) has become a key step in the postoperative treatment of differentiated thyroid cancer (DTC). However, inadequate or excessive 131 I is common using fixed activities. This study was designed to explore the feasibility of radioiodine uptake and thyroglobulin (RAIU-Tg)-guided RRA.
METHODS: A total of 277 patients were randomized to the RAIU-Tg-based activity group or a fixed activity of 3.7 GBq group at a ratio of 4:1. The RAIU-Tg-based activity was established based on four levels of RAIU (≤2%, 2-5%, 5-15%, and >15%) and Tg levels (≤2, 2-5, 5-10, and >10 ng/mL). Based on this, 131 I activities of 1.1, 1.85, 3.7, and 5.55 GBq were administered. If the levels for RAIU and Tg were not in the same category, the higher activity determined by either RAIU or Tg was administered. Successful RRA was defined as negative diagnostic whole-body scan and Tg <1 ng/mL (anti-Tg antibody negative) or negative diagnostic whole-body scan (anti-Tg antibody positive) under thyrotropin stimulation six months or more post RRA.
RESULTS: There was no statistically significant difference in baseline characteristics between the RAIU-Tg-based activity group (n = 207) and the fixed activity group (n = 58). The activity of 131 I used in the RAIU-Tg-based activity group (3.26 ± 1.54 GBq) was significantly lower than that used in the fixed activity group (p < 0.0001), whereas the rate of successful RRA in the RAIU-Tg-based activity group was significantly higher than the rate in the fixed activity group (94.2% vs. 70.7%; p < 0.0001). The rates of successful RRA in the four subgroups of the RAIU-Tg-based activity group were comparable (p = 0.543). Although there was no statistically significant difference in the incidence of total/short-term adverse effects between the RAIU-Tg-based activity group and the fixed activity group, a significantly lower incidence of intermediate adverse effects, which predominantly consisted of xerostomia, was reported in the RAIU-Tg-based activity group.
CONCLUSIONS: Compared to a fixed activity of 3.7 GBq, RAIU-Tg-guided dosimetry can improve the success rate and decrease the incidence of intermediate side effects of RRA in postoperative patients with DTC.
METHODS: A total of 277 patients were randomized to the RAIU-Tg-based activity group or a fixed activity of 3.7 GBq group at a ratio of 4:1. The RAIU-Tg-based activity was established based on four levels of RAIU (≤2%, 2-5%, 5-15%, and >15%) and Tg levels (≤2, 2-5, 5-10, and >10 ng/mL). Based on this, 131 I activities of 1.1, 1.85, 3.7, and 5.55 GBq were administered. If the levels for RAIU and Tg were not in the same category, the higher activity determined by either RAIU or Tg was administered. Successful RRA was defined as negative diagnostic whole-body scan and Tg <1 ng/mL (anti-Tg antibody negative) or negative diagnostic whole-body scan (anti-Tg antibody positive) under thyrotropin stimulation six months or more post RRA.
RESULTS: There was no statistically significant difference in baseline characteristics between the RAIU-Tg-based activity group (n = 207) and the fixed activity group (n = 58). The activity of 131 I used in the RAIU-Tg-based activity group (3.26 ± 1.54 GBq) was significantly lower than that used in the fixed activity group (p < 0.0001), whereas the rate of successful RRA in the RAIU-Tg-based activity group was significantly higher than the rate in the fixed activity group (94.2% vs. 70.7%; p < 0.0001). The rates of successful RRA in the four subgroups of the RAIU-Tg-based activity group were comparable (p = 0.543). Although there was no statistically significant difference in the incidence of total/short-term adverse effects between the RAIU-Tg-based activity group and the fixed activity group, a significantly lower incidence of intermediate adverse effects, which predominantly consisted of xerostomia, was reported in the RAIU-Tg-based activity group.
CONCLUSIONS: Compared to a fixed activity of 3.7 GBq, RAIU-Tg-guided dosimetry can improve the success rate and decrease the incidence of intermediate side effects of RRA in postoperative patients with DTC.
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