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Purpose <p>[<sup>99m</sup>Tc]Tc-HYNIC-PSMA-XL-2 is a PSMA-targeted SPECT tracer with low urinary bladder activity. We assessed its real-world performance in paired head-to-head comparisons versus [<sup>99m</sup>Tc]Tc-MDP and PSMA PET/CT.</p> Methods <p>Single-center retrospective study (Jan 1, 2020–Nov 25, 2025) using within-patient paired scans within 30 days. Subcohort A included [<sup>99m</sup>Tc]Tc-HYNIC-PSMA-XL-2 SPECT/CT vs. [<sup>99m</sup>Tc]Tc-MDP (<i>n</i> = 38). Subcohort B included [<sup>99m</sup>Tc]Tc-HYNIC-PSMA-XL-2 SPECT/CT vs. PSMA PET/CT (either [<sup>68</sup>Ga]Ga-PSMA-11 or [<sup>18</sup>F]PSMA-1007; <i>n</i> = 13). Lesions were classified by a composite reference standard (Gold+/Gold−). Sensitivity/specificity/accuracy were compared with McNemar’s test; non-inferiority versus PET/CT used Δ = 10% (sensitivity and accuracy).</p> Results <p>In Subcohort A, 76 bone lesions were evaluated (Gold + 60, Gold − 16). Sensitivity was high for both modalities (MDP 100.0% vs. [<sup>99m</sup>Tc]Tc-HYNIC-PSMA-XL-2 98.3%; <i>P</i> = 1.000). [<sup>99m</sup>Tc]Tc-HYNIC-PSMA-XL-2 showed higher specificity (100.0% vs. 18.8%; <i>P</i> &lt; 0.001) and accuracy (98.7% vs. 82.9%; <i>P</i> &lt; 0.001), with fewer false positives (FP 0 vs. 13). In Subcohort B, overall lesion sensitivity was comparable (93.1% vs. 96.6%; <i>P</i> = 1.000), and non-inferiority criteria were met (Δ = 10%); specificity estimates were limited by few Gold− lesions.</p> Conclusion <p>[<sup>99m</sup>Tc]Tc-HYNIC-PSMA-XL-2 SPECT/CT reduces false-positive bone findings versus [<sup>99m</sup>Tc]Tc-MDP and meets prespecified non-inferiority criteria versus PSMA PET/CT, supporting its potential as an accessible PSMA imaging option.</p>

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Clinical performance of [99mTc]Tc-HYNIC-PSMA-XL-2 SPECT/CT in prostate cancer: paired head-to-head comparisons with [99mTc]Tc-MDP and PSMA PET/CT

  • 期刊论文

  • 发表日期：

    2026年2月13日

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  • Linjie Bian,
  • Chang Liu,
  • Xiaoping Xu,
  • Shaoli Song

摘要

Purpose

[99mTc]Tc-HYNIC-PSMA-XL-2 is a PSMA-targeted SPECT tracer with low urinary bladder activity. We assessed its real-world performance in paired head-to-head comparisons versus [99mTc]Tc-MDP and PSMA PET/CT.

Methods

Single-center retrospective study (Jan 1, 2020–Nov 25, 2025) using within-patient paired scans within 30 days. Subcohort A included [99mTc]Tc-HYNIC-PSMA-XL-2 SPECT/CT vs. [99mTc]Tc-MDP (n = 38). Subcohort B included [99mTc]Tc-HYNIC-PSMA-XL-2 SPECT/CT vs. PSMA PET/CT (either [68Ga]Ga-PSMA-11 or [18F]PSMA-1007; n = 13). Lesions were classified by a composite reference standard (Gold+/Gold−). Sensitivity/specificity/accuracy were compared with McNemar’s test; non-inferiority versus PET/CT used Δ = 10% (sensitivity and accuracy).

Results

In Subcohort A, 76 bone lesions were evaluated (Gold + 60, Gold − 16). Sensitivity was high for both modalities (MDP 100.0% vs. [99mTc]Tc-HYNIC-PSMA-XL-2 98.3%; P = 1.000). [99mTc]Tc-HYNIC-PSMA-XL-2 showed higher specificity (100.0% vs. 18.8%; P < 0.001) and accuracy (98.7% vs. 82.9%; P < 0.001), with fewer false positives (FP 0 vs. 13). In Subcohort B, overall lesion sensitivity was comparable (93.1% vs. 96.6%; P = 1.000), and non-inferiority criteria were met (Δ = 10%); specificity estimates were limited by few Gold− lesions.

Conclusion

[99mTc]Tc-HYNIC-PSMA-XL-2 SPECT/CT reduces false-positive bone findings versus [99mTc]Tc-MDP and meets prespecified non-inferiority criteria versus PSMA PET/CT, supporting its potential as an accessible PSMA imaging option.