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Background <p>Primary Sjögren’s syndrome (pSS) is characterized by progressive fibro-inflammatory glandular injury. While conventional salivary gland scintigraphy (SGS) provides macroscopic functional assessment, it cannot visualize underlying active fibrotic remodeling. This prospective study aimed to evaluate the diagnostic performance of dual-time-point (10 and 40&#xa0;min post-injection) [<sup>68</sup>Ga]Ga-FAPI-04 PET/CT—a novel radiotracer targeting activated fibroblasts—compared to SGS in patients with suspected pSS.</p> Results <p>Among 21 participants (15 with confirmed pSS, 6 non-SS controls with other autoimmune diseases), early-phase (10-minute) PET/CT achieved optimal diagnostic efficacy. Visually, early-phase PET/CT demonstrated substantially higher specificity (66.7% vs. 16.7%), positive predictive value (87.5% vs. 73.7%), and overall accuracy (85.7% vs. 71.4%) compared to SGS, while maintaining comparable high sensitivity (93.3%). Semiquantitatively, the SUVmax of the submandibular and sublingual glands exhibited significant diagnostic utility (AUC &gt; 0.5, <i>P</i> &lt; 0.05), achieving 100% specificity and significantly outperforming volumetric parameters, which were compromised by a “background dilution effect.” Clinically, early-phase global FAPI burden (TLF) correlated negatively with the systemic erythrocyte sedimentation rate (ESR). Regionally, early submandibular FTV correlated positively with the SGS excretion fraction (<i>r</i> = 0.594, <i>P</i> = 0.019), whereas the parotid glands exhibited no such correlation, corroborating the asynchronous structural progression of pSS. Furthermore, whole-body PET/CT successfully detected incidental extra-salivary fibro-inflammatory comorbidities (e.g., Hashimoto’s thyroiditis, osteoarthritis).</p> Conclusions <p>[<sup>68</sup>Ga]Ga-FAPI-04 PET/CT demonstrates promising diagnostic utility and high specificity for pSS by selectively visualizing active fibroblast activation. It elegantly complements the macroscopic functional evaluation of SGS while providing profound in vivo insights into asynchronous disease progression. Crucially, its whole-body imaging capability delivers unparalleled clinical value for mapping systemic, multi-organ comorbidities. These findings underscore its potential as an advanced adjunctive diagnostic tool, warranting rigorous validation in large-scale, multicenter prospective cohorts.</p>

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Prospective comparison of [68Ga]Ga-FAPI-04 PET/CT and salivary gland scintigraphy for the diagnosis of primary Sjögren’s syndrome

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月5日

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  • Ke Cheng,
  • Tingting Xu,
  • Zhuoyuan Li,
  • Guangfu Liu,
  • Rui Sun,
  • Qingxue Shu,
  • Yue Chen

摘要

Background

Primary Sjögren’s syndrome (pSS) is characterized by progressive fibro-inflammatory glandular injury. While conventional salivary gland scintigraphy (SGS) provides macroscopic functional assessment, it cannot visualize underlying active fibrotic remodeling. This prospective study aimed to evaluate the diagnostic performance of dual-time-point (10 and 40 min post-injection) [68Ga]Ga-FAPI-04 PET/CT—a novel radiotracer targeting activated fibroblasts—compared to SGS in patients with suspected pSS.

Results

Among 21 participants (15 with confirmed pSS, 6 non-SS controls with other autoimmune diseases), early-phase (10-minute) PET/CT achieved optimal diagnostic efficacy. Visually, early-phase PET/CT demonstrated substantially higher specificity (66.7% vs. 16.7%), positive predictive value (87.5% vs. 73.7%), and overall accuracy (85.7% vs. 71.4%) compared to SGS, while maintaining comparable high sensitivity (93.3%). Semiquantitatively, the SUVmax of the submandibular and sublingual glands exhibited significant diagnostic utility (AUC > 0.5, P < 0.05), achieving 100% specificity and significantly outperforming volumetric parameters, which were compromised by a “background dilution effect.” Clinically, early-phase global FAPI burden (TLF) correlated negatively with the systemic erythrocyte sedimentation rate (ESR). Regionally, early submandibular FTV correlated positively with the SGS excretion fraction (r = 0.594, P = 0.019), whereas the parotid glands exhibited no such correlation, corroborating the asynchronous structural progression of pSS. Furthermore, whole-body PET/CT successfully detected incidental extra-salivary fibro-inflammatory comorbidities (e.g., Hashimoto’s thyroiditis, osteoarthritis).

Conclusions

[68Ga]Ga-FAPI-04 PET/CT demonstrates promising diagnostic utility and high specificity for pSS by selectively visualizing active fibroblast activation. It elegantly complements the macroscopic functional evaluation of SGS while providing profound in vivo insights into asynchronous disease progression. Crucially, its whole-body imaging capability delivers unparalleled clinical value for mapping systemic, multi-organ comorbidities. These findings underscore its potential as an advanced adjunctive diagnostic tool, warranting rigorous validation in large-scale, multicenter prospective cohorts.