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A phase 2, open-label, multi-center study to evaluate the efficacy and safety of 99mTc-TRODAT-1 SPECT to detect Parkinson’s disease

  • Yu Sun
  • Congjin Liu
  • Zhengping Chen
  • Biao Li
  • Zhongwei Lv
  • Jian Wang
  • Jingjing LouEmail author
  • Jie Tang
  • Yuankai Wang
  • Guangming Zhang
  • Xingdang LiuEmail author
Original Article
  • 77 Downloads

Abstract

Objectives

To assess the efficacy and safety of 99mTc-TRODAT-1 SPECT in diagnosing Parkinson’s disease (PD).

Methods

99mTc-TRODAT-1 SPECT imaging was performed in 34 healthy controls and 96 PD patients 2.5 h later after injection. The striatal image was evaluated visually and semi-quantitively. Sensitivity and specificity of 99mTc-TRODAT-1 SPECT were analyzed according to Hoehn and Yahr scale (HYS). Based on HYS, the PD patients were divided into mild (HYS 1–2) and moderate (HYS 3–5) groups. The uptake ratios of striatum (ST) and cerebellum (CB) in contralateral, ipsilateral and bilateral striatum in different groups were calculated and analyzed. The safety was assessed.

Results

The sensitivity and specificity of 99mTc-TRODAT-1 SPECT to discriminate PD patients from healthy subjects were 98.96% and 94.12% and it has perfect agreement with HYS (κ = 0.94, p < 0.001). The sensitivity to diagnose mild and moderate PD was 43.42% and 95% separately. The uptake ratio in PD patients was significantly lower than that in healthy controls (1.37 ± 0.13 vs 1.68 ± 0.18, p < 0.001). And the uptake ratio in contralateral side was markedly reduced in unilateral PD patients as compared with the ipsilateral side (1.50 ± 0.20 vs 1.46 ± 0.21, p < 0.001). The striatal uptakes in affected striatum and bilateral striatum were reduced with increasing disease severity between healthy control versus mild stage versus moderate stage in the affected striatum and bilateral striatum in PD patients. No serious adverse events or death was observed after injecting 99mTc-TRODAT-1.

Conclusion

We demonstrated that 99mTc-TRODAT-1 was a safety radiotracer which can be used in clinic to diagnose PD using SPECT.

Keywords

Phase 2 clinical trial 99mTc-TRODAT-1 Dopamine transporter Diagnostic efficacy Parkinson’s disease 

Notes

Funding

None.

Compliance with ethical standards

Conflicts of interest

No potential conflicts of interest were disclosed.

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Copyright information

© The Japanese Society of Nuclear Medicine 2019

Authors and Affiliations

  • Yu Sun
    • 1
  • Congjin Liu
    • 1
  • Zhengping Chen
    • 2
  • Biao Li
    • 3
  • Zhongwei Lv
    • 4
  • Jian Wang
    • 5
  • Jingjing Lou
    • 6
    Email author
  • Jie Tang
    • 2
  • Yuankai Wang
    • 1
  • Guangming Zhang
    • 1
  • Xingdang Liu
    • 1
    Email author
  1. 1.Department of Nuclear Medicine, Huashan HospitalFudan UniversityShanghaiChina
  2. 2.Key Laboratory of Nuclear Medicine, Ministry of HealthJiangsu Key Laboratory of Molecular Nuclear MedicineWuxiChina
  3. 3.Department of Nuclear Medicine, Ruijin HospitalShanghai Jiaotong UniversityShanghaiChina
  4. 4.Department of Nuclear Medicine, Shanghai Tenth People’s HospitalTongji University School of MedicineShanghaiChina
  5. 5.Department of Neurology and National Clinical Research Center for Aging and Medicine, Huashan HospitalFudan UniversityShanghaiChina
  6. 6.Universal Medical Imaging Diagnostic CenterShanghaiChina

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