Trial reportEuropean journal of nuclear medicine and molecular imaging2025
RhTSH in aiding dynamic assessment in patients with differentiated thyroid Cancer.
Trial report in European journal of nuclear medicine and molecular imaging, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04971473 (An Open, Single-arm, Self-controlled, Multi-center Phase 3 Study to Compare the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open, Single-arm, Self-controlled, Multi-center Phase 3 Study to Compare the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal
Who cites it
1 citing paper in PubMed.
- Cervical lymph node response to 131I therapy in differentiated thyroid cancer using radiomics and clinical features.Frontiers in oncology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors.
Funding
Abstract
purposeTo evaluate the efficacy of a novel recombinant human thyroid-stimulating hormone (ZGrhTSH) as an alternative to thyroid hormone withdrawal (THW) in dynamic assessment of DTC patients.
methodsThis phase 3, open-label, multicenter trial, conducted across 27 sites in China, employed a self-controlled design to enroll patients. Eligible patients had previously undergone total or near-total thyroidectomy, with or without RAI therapy. During both the ZGrhTSH-stimulated phase and the THW phase, Dx-WBS and serum Tg measurements were performed on all participants. The study focused on the concordance of Dx-WBS results, stimulated Tg levels, and their combination in patients across the two phases. Additionally, the safety and immunogenicity profiles of ZGrhTSH were assessed as well.
resultsIn the assessment of radioiodine uptake and stimulated Tg levels, ZGrhTSH demonstrated efficacy comparable to that of THW. The concordance rate for scans between the two phases was 88.2% (95% CI: 83.7-92.7%). When setting stimulated Tg levels with a cutoff of 1 ng/mL, the concordance rate was 90.4% (95% CI: 86.1-94.6%), and the concordance of scans combined with stimulated Tg was 93.6% (95% CI: 90.1-97.1%). Adverse events associated with ZGrhTSH were reported in 22 patients (10.9%), all of which were mild and transient, graded as 1 or 2.
conclusionZGrhTSH showed non-inferior performance in detecting radioiodine uptake and serum Tg, and could be an effective and safe alternative for the dynamic evaluation of DTC patients.
trial registrationClinicalTrials.gov, NCT04971473. Registered July 7, 2021.
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