Human dose-escalation study of PET imaging CD8+ T-cell infiltration in solid malignancies with [68Ga]Ga -NODAGA-SNA006.

Purpose: A noninvasive method for evaluating the infiltration of CD8+ T cells in tumors is urgently needed to monitor the response to immunotherapy. This study investigated the performance of a [68Ga]Ga-NODAGA-SNA006 in positron emission tomography (PET) imaging of CD8+ T cells in patients with soli...

Full description

Bibliographic Details
Published in:European Journal of Nuclear Medicine & Molecular Imaging Vol. 52; no. 4; pp. 1332 - 1345
Main Authors: Wang, Yan, Zheng, Meng, Zhao, Jun, Wang, Chao, Zhao, Shandong, Bian, Yicong, Dai, Na, Zheng, Yushuang, Sang, Shibiao, Guo, Linchuan, Huang, Chenrong, Zhang, Hua, Jiang, Jiwei, Xu, Chun, Zhao, Qi, Han, Jiajun, Xu, Tao, Qin, Songbing, Miao, Liyan
Format: Journal Article
Published: Springer Nature Mar2025
Online Access:View this record in EBSCOhost
fields @attributes:
  recordID: 1
pdfLink:
plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=183131169&site=ehost-live
header:
  @attributes:
    shortDbName: ccm
    uiTerm: 183131169
    longDbName: CINAHL Complete
    uiTag: AN
  controlInfo:
    bkinfo:
    dissinfo:
    jinfo:
      jid:
        16197070
        NPC
      jtl: European Journal of Nuclear Medicine & Molecular Imaging
      issn: 16197070
      maglogo: N
    pubinfo:
      dt: Mar2025
      vid: 52
      iid: 4
      pid: 237
      pub: Springer Nature
      place: New York, New York
    artinfo:
      ui:
        183131169
        181511473
        10.1007/s00259-024-06999-x
        183131169
      ppf: 1332
      ppct: 13
      formats:
        fmt:
          – @attributes:
              type: T
          – @attributes:
              type: P
      tig:
        atl: Human dose-escalation study of PET imaging CD8+ T-cell infiltration in solid malignancies with [68Ga]Ga -NODAGA-SNA006.
      aug:
        au:
          Wang, Yan
          Zheng, Meng
          Zhao, Jun
          Wang, Chao
          Zhao, Shandong
          Bian, Yicong
          Dai, Na
          Zheng, Yushuang
          Sang, Shibiao
          Guo, Linchuan
          Huang, Chenrong
          Zhang, Hua
          Jiang, Jiwei
          Xu, Chun
          Zhao, Qi
          Han, Jiajun
          Xu, Tao
          Qin, Songbing
          Miao, Liyan
        affil: https://ror.org/051jg5p78 Department of Clinical Pharmacology, First Affiliated Hospital of Soochow University, Suzhou, China
      sug:
      ab: Purpose: A noninvasive method for evaluating the infiltration of CD8+ T cells in tumors is urgently needed to monitor the response to immunotherapy. This study investigated the performance of a [68Ga]Ga-NODAGA-SNA006 in positron emission tomography (PET) imaging of CD8+ T cells in patients with solid malignancies. Methods: This human dose-escalation PET imaging study involved eleven patients (lung cancer, 8; gastric carcinoma, 1; esophageal carcinoma, 2). Approximately 150 MBq of [68Ga]Ga-NODAGA-SNA006 with varying nanobody masses (100 µg, 300 µg, 500 µg, 800 µg) was administered, and PET/computed tomography (CT) scans were performed at 15–30, 60–90 and 120 min postinjection (p.i.). Data regarding biodistribution, pharmacokinetics and radiation dosimetry were evaluated. CD8+ T-cell infiltration in biopsy samples was also measured via immunohistochemistry (IHC) for correlation analysis with the tumor uptake of [68Ga]Ga-NODAGA-SNA006 PET. Results: [68Ga]Ga-NODAGA-SNA006 was well tolerated by all eleven subjects. The highest radioactive uptake was observed in the spleen, followed by the kidneys and bladder. Liver uptake decreased with increasing nanobody mass. Rapid clearance (t1/2<30 min) of [68Ga]Ga-NODAGA-SNA006 from whole blood and serum was observed. Furthermore, 68Ga uptake in tumors (SUVmean) exhibited a linear relationship with CD8+ T-cell infiltration in biopsy samples (R2 = 0.757, p = 0.011), suggesting that the tumor uptake of [68Ga]Ga-NODAGA-SNA006 may represent the degree of CD8+ T-cell infiltration in the tumor. Conclusion: The use of [68Ga]Ga-NODAGA-SNA006 is safe, feasible, and well tolerated. [68Ga]Ga-NONAGA-SNA006 PET imaging can accurately detect CD8 expression inside tumors with favorable pharmacokinetics, thus providing a feasible method for noninvasive quantitative assessment of CD8+ T-cell tumor infiltration and monitoring the response to immunotherapy. Trial Registration: NCT05126927 (19 November 2021, retrospectively registered).
      pubtype: Academic Journal
      doctype: Journal Article
      ougenre: Article
    language: English
    refInfo:
    holdings:
      @attributes:
        islocal: N