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Background <p>To evaluate whether <sup>99m</sup>Tc-MIP-1404 CZT SPECT/CT is non-inferior to <sup>68</sup>Ga-PSMA-11 PET/CT for metastases detection in patients with newly diagnosed high risk prostate cancer (PCa). Patients with newly diagnosed high-risk PCa (age range 50–79 years, mean 66) underwent three imaging modalities: 99mTc-HDP CZT SPECT/CT, 68Ga-PSMA-11 PET/CE-CT (contrast-enhanced CT), and 99mTc-MIP-1404 CZT SPECT/CT. Metastatic involvement of lymph nodes (LN) and bones were recorded. Repeated-measures ANOVAs and post-hoc analyses were used to compare modality performance. Sensitivity and specificity for LN and skeletal lesions were calculated based on PET scans as the reference standard. 99mTc-MIP-1404 CZT SPECT/CT-based therapy decisions were compared to 68Ga-PSMA-11 PET/CT-based decisions.</p> Results <p>Sensitivity of <sup>99m</sup>Tc-MIP-1404 CZT SPECT/CT for metastasis detection at the patient level was 81% for LN metastasis and 85% for bone metastases, compared with 57% for bone metastases by <sup>99m</sup>Tc-HDP CZT SPECT/CT. There were no false positive findings by <sup>99m</sup>Tc-MIP-1404 CZT SPECT/CT; specificity was 100% compared to <sup>68</sup>Ga-PSMA-11 PET/CE-CT. At lesion level analysis, <sup>99m</sup>Tc-MIP-1404 CZT SPECT/CT had significantly higher detection rate of LN metastases compared with CE-CT (<i>p</i> = 0.026), but a lower detection rate compared to <sup>68</sup>Ga-PSMA-11 PET/CE-CT (<i>p</i> = 0.003). Classification of metastasis burden into high volume metastasis (HVM) and low volume metastasis (LVM) was concordant in 85% of cases based on <sup>99m</sup>Tc-MIP-1404 CZT SPECT/CT compared to <sup>68</sup>Ga-PSMA-11 PET/CE-CT, while conventional imaging agreed in 64% of cases. Therapy decisions based on <sup>99m</sup>Tc-MIP-1404 CZT SPECT/CT were concordant with those based on <sup>68</sup>Ga-PSMA-11 PET/CE-CT in 91% (30/33) of patients.</p> Conclusions <p><sup>99m</sup>Tc-MIP-1404 CZT SPECT/CT demonstrates strong diagnostic capability for metastatic staging and therapy planning in newly diagnosed high-risk PCa, outperforming conventional imaging. While <sup>68</sup>Ga-PSMA-11 PET/CE-CT identified more additional lesions, concordance in treatment decisions remained high. Considering its broader accessibility, <sup>99m</sup>Tc-MIP-1404 CZT SPECT/CT may represent a practical alternative for primary staging, especially in settings with limited PET/CT availability. The study was approved by the Swedish Ethical Review Authority (approval number 2021 − 01642) and the Swedish Medical Products Agency (EudraCT-number 2021-001059-15). Trial registration date 16th February 2022.</p>

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Head-to-head comparison of 99mTc-MIP-1404 CZT SPECT/CT and 68Ga/PSMA-11 PET/CT for primary staging of high-risk prostate cancer: a phase II study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月22日

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  • Aws Saudi,
  • Malin Ståhlgren,
  • Prab Takhar,
  • Pernilla Norberg,
  • Martin Holmbom,
  • Julia Dahl,
  • Mostafa Afshar,
  • Isidro Albert-García,
  • Jon Forsberg,
  • Marcus Ressner,
  • Mathias Elgland,
  • Veronica Sanchez-Rodriguez,
  • Firas Aljabery,
  • Miguel Ochoa-Figueroa

摘要

Background

To evaluate whether 99mTc-MIP-1404 CZT SPECT/CT is non-inferior to 68Ga-PSMA-11 PET/CT for metastases detection in patients with newly diagnosed high risk prostate cancer (PCa). Patients with newly diagnosed high-risk PCa (age range 50–79 years, mean 66) underwent three imaging modalities: 99mTc-HDP CZT SPECT/CT, 68Ga-PSMA-11 PET/CE-CT (contrast-enhanced CT), and 99mTc-MIP-1404 CZT SPECT/CT. Metastatic involvement of lymph nodes (LN) and bones were recorded. Repeated-measures ANOVAs and post-hoc analyses were used to compare modality performance. Sensitivity and specificity for LN and skeletal lesions were calculated based on PET scans as the reference standard. 99mTc-MIP-1404 CZT SPECT/CT-based therapy decisions were compared to 68Ga-PSMA-11 PET/CT-based decisions.

Results

Sensitivity of 99mTc-MIP-1404 CZT SPECT/CT for metastasis detection at the patient level was 81% for LN metastasis and 85% for bone metastases, compared with 57% for bone metastases by 99mTc-HDP CZT SPECT/CT. There were no false positive findings by 99mTc-MIP-1404 CZT SPECT/CT; specificity was 100% compared to 68Ga-PSMA-11 PET/CE-CT. At lesion level analysis, 99mTc-MIP-1404 CZT SPECT/CT had significantly higher detection rate of LN metastases compared with CE-CT (p = 0.026), but a lower detection rate compared to 68Ga-PSMA-11 PET/CE-CT (p = 0.003). Classification of metastasis burden into high volume metastasis (HVM) and low volume metastasis (LVM) was concordant in 85% of cases based on 99mTc-MIP-1404 CZT SPECT/CT compared to 68Ga-PSMA-11 PET/CE-CT, while conventional imaging agreed in 64% of cases. Therapy decisions based on 99mTc-MIP-1404 CZT SPECT/CT were concordant with those based on 68Ga-PSMA-11 PET/CE-CT in 91% (30/33) of patients.

Conclusions

99mTc-MIP-1404 CZT SPECT/CT demonstrates strong diagnostic capability for metastatic staging and therapy planning in newly diagnosed high-risk PCa, outperforming conventional imaging. While 68Ga-PSMA-11 PET/CE-CT identified more additional lesions, concordance in treatment decisions remained high. Considering its broader accessibility, 99mTc-MIP-1404 CZT SPECT/CT may represent a practical alternative for primary staging, especially in settings with limited PET/CT availability. The study was approved by the Swedish Ethical Review Authority (approval number 2021 − 01642) and the Swedish Medical Products Agency (EudraCT-number 2021-001059-15). Trial registration date 16th February 2022.