Stimulator of interferon gene (STING) protein plays a vital role in the immune surveillance of tumor microenvironment. Monitoring STING expression in tumors benefits the relevant STING therapy. This study will investigate the safety, biodistribution and potential usefulness of a novel 68Ga-labeled agonist ([68Ga]Ga-Sa-DABI-4) for noninvasive positron emission tomography (PET) imaging of STING expression in the tumor microenvironment.

Start Date21 May 2024

Sponsor / Collaborator

First Affiliated Hospital of Chongqing Medical University

100 Clinical Results associated with [68Ga]Ga-Sa-DABI-4

100 Translational Medicine associated with [68Ga]Ga-Sa-DABI-4

100 Patents (Medical) associated with [68Ga]Ga-Sa-DABI-4

Literatures (Medical) associated with [68Ga]Ga-Sa-DABI-4

01 Jun 2024·Translational Cancer Research

Head-to-head comparison of [68Ga]Ga-FAPI-04 PET and [18F]FDG PET in the detection of cancer recurrence: a systematic review and meta-analysis

Article

Author: Huang, Chao ; Wang, Chen ; Wu, Qinchao ; Li, Dan

BackgroundThe comparative diagnostic performance of [⁶⁸Ga]Ga-fibroblast activation protein inhibitors-04 {[⁶⁸Ga]Ga-FAPI-04} positron emission tomography (PET) and fluorodeoxyglucose F 18 {[¹⁸F]FDG} PET in identifying cancer recurrence remains uncertain. The purpose of our study was to compare the diagnostic performance of [⁶⁸Ga]Ga-FAPI-04 PET and [¹⁸F]FDG PET imaging in cancer recurrence.MethodsUp until March 1, 2024, we searched PubMed, Embase, and Web of Science for pertinent papers. Studies examining the diagnostic utility of [⁶⁸Ga]Ga-FAPI-04 PET and [18F]FDG PET for cancer recurrence were included. Using a bivariate fixed-effect model and random-effect model, the pooled sensitivity and specificity for [⁶⁸Ga]Ga-FAPI-04 PET and [¹⁸F]FDG PET were reported as estimates with 95% confidence intervals (CIs). The I2 statistic was used to evaluate the heterogeneity among the pooled studies. The included studies' quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) approach.ResultsIn all, 508 papers were found during the first search; ultimately, 12 studies totaling 224 patients were included. The pooled sensitivity of [⁶⁸Ga]Ga-FAPI-04 PET and [¹⁸F]FDG PET for cancer recurrence were 0.97 (95% CI: 0.90-1.00) and 0.69 (95% CI: 0.60-0.77). The pooled sensitivity of [⁶⁸Ga]Ga-FAPI-04 PET and [¹⁸F]FDG PET for gastrointestinal cancer recurrence were 1.00 (95% CI: 0.97-1.00) and 0.57 (95% CI: 0.42-0.74). The pooled specificity of [⁶⁸Ga]Ga-FAPI-04 PET and [¹⁸F]FDG PET for gastrointestinal cancer recurrence were 0.66 (95% CI: 0.15-1.00) and 0.46 (95% CI, 0.00-1.00).ConclusionsBased on the previous studies, [⁶⁸Ga]Ga-FAPI-04 PET shows higher sensitivity compared to [¹⁸F]FDG PET in detecting tumor recurrence, especially in detecting gastrointestinal cancer recurrence. [⁶⁸Ga]Ga-FAPI-04 PET shows similar specificity compared to [¹⁸F]FDG PET in detecting gastrointestinal cancer recurrence. The detection results, however, came from investigations using modest sample numbers. In this matter, more extensive prospective study is required.

01 Jan 2024·Asia Oceania journal of nuclear medicine & biology

On the Optimization of the Protocol for Automated Radiosyntheses of [⁶⁸Ga]Ga-Pentixafor, [⁶⁸Ga]Ga-FAPI-4 and [⁶⁸Ga]Ga-DOTATATE in a Modular-Lab Standard.

Article

Author: Sahu, Sudeep ; Lad, Sangita ; Ray, Mukti Kanta ; Banerjee, Sharmila ; Chakraborty, Avik ; Menon, Sreeja Raj ; Mitra, Arpit

ObjectivesThe present work describes the automated radiochemical synthesis of different PET tracers like [⁶⁸Ga]Ga-Pentixafor, [⁶⁸Ga]Ga-FAPI-4 and [⁶⁸Ga]Ga-DOTATATE using optimized single protocol in the non-cassette based Eckert & Ziegler (EZ) Modular Lab (fixed tubing system) without any modification in the inbuilt human machine interface (HMI) software. Recently, PET agents viz. [⁶⁸Ga]Ga-Pentixafor and [⁶⁸Ga]Ga-FAPI-4 are gaining prominence for the diagnosis of overexpressed Chemokine Receptor-4 (CXCR4) and Fibroblast Activation Protein (FAP) receptor, respectively, in the microenvironment of numerous cancer types. The promising results observed with the clinical usage of [⁶⁸Ga]Ga-DOTATATE produced using the automated protocol, provided impetus for the clinical translation of [⁶⁸Ga]Ga-Pentixafor and [⁶⁸Ga]Ga-FAPI-4 using the in-house developed automated radiolabeling protocol.MethodsHerein we report a single radiolabeling protocol for the automated preparation of [⁶⁸Ga]Ga-Pentixafor and [⁶⁸Ga]Ga-FAPI-4 in the non-cassette based EZ Modular-Lab Standard radiochemistry module, without any changes in schematic, graphical user interface (GUI) software and time list, from that used for routine production of [⁶⁸Ga]Ga-DOTATATE in our centre, since 2015. Physico-chemical quality control and in-vitro stability analyses were carried out using radio-TLC and radio-HPLC.ResultsThe automated protocol yielded reliable and consistent non-decay corrected (ndc) radiochemical yield (RCY) of (84.4%±0.9%) and (85.5%±1.4%) respectively, for [⁶⁸Ga]Ga-Pentixafor and [⁶⁸Ga]Ga-FAPI-4, with RCP>98%, which are comparable to the RCY of (84.4%±1.2%) and RCP (99.1%±0.3%) for [⁶⁸Ga]Ga-DOTATATE. The biological quality control studies confirmed the formulations to be of ready-to-use pharmaceutical grade.ConclusionThe consistent and reliable RCY and RCP of multiple ⁶⁸Ga-labeled PET tracers by single automated radiochemistry protocol exhibits the versatility of the EZ Modular Lab.

European Journal of Nuclear Medicine and Molecular Imaging

Exploration the feasibility and additional value of [18F]FDG/[68Ga]Ga-FAPI-04 dual-low-activity-tracer one-stop total-body PET imaging at 34 min post-injection of [68Ga]Ga-FAPI-04

Article

Author: Hu, Pengcheng ; Shi, Hongcheng ; Yang, Runjun ; He, Yibo ; Yu, Haojun ; Zheng, Zhe ; Wu, Ha ; Mao, Wujian ; Gao, Huaping

OBJECTIVESTo validate the feasibility of one-stop 2-[¹⁸F]fluoro-2-deoxy-D-glucose ([¹⁸F]FDG) and [⁶⁸Ga]Ga-fibroblast activation protein inhibitor-04 ([⁶⁸Ga]Ga-FAPI-04) dual-low-activity-tracer positron emission tomography/computed tomography (PET/CT) at 34 min post-injection of [⁶⁸Ga]Ga-FAPI-04 and explore its additional value.METHODSThirty pairs of patients with suspected malignancies who underwent dual-tracer imaging were enrolled in this retrospective study. The images were reconstructed at 34-39 and 50-60 min after additional injection of [⁶⁸Ga]Ga-FAPI-04 (in one-stop FDG-FAPI PET/CT, named PET_FDG, PET_D34-39, and PET_D50-60; in the 2-day protocol, named PET_FDG', PET_F34-39, and PET_F50-60, respectively). Tumour-to-normal ratios (TNR) of lesions in PET_FDG, PET_D34-39, and PET_D50-60 and TNR of lesions in PET_F34-39 and PET_F50-60 were evaluated separately. To evaluate the potential added value of one-stop FDG-FAPI PET/CT over the 2-day protocol, TNRs of PET_FDG, PET_D34-39, and PET_D50-60 were compared with PET_F34-39. The lesion detectability of the two imaging protocols was evaluated by chi-square test.RESULTSComparing FAPI-weighted PET (PET_D34-39 and PET_D50-60) and single-tracer imaging (PET_FDG) in one-stop FDG-FAPI PET/CT, TNRs of FAPI-weighted PET were higher than those of PET_FDG. PET_D34-39 and PET_D50-60 showed similar performance in lesion detectability and TNRs (all P > 0.05). In the 2-day protocol, there are no statistically significant differences in TNRs of all lesions at PET_F34-39 and PET_F50-60. Comparing one-stop FDG-FAPI PET/CT with the 2-day protocol, TNRs of PET_F34-39 were significantly higher than those of PET_FDG but lower than those of PET_D34-39 and PET_D50-60. Lesion detectability in the one-stop FDG-FAPI PET/CT was higher than that in the 2-day protocol. The average radiation dose in one-stop FDG-FAPI PET/CT was significantly lower than that in the 2-day protocol (P<0.001).CONCLUSIONOne-stop FDG-FAPI PET/CT at 34 min could provide sufficient information to meet clinical diagnosis and showed better lesion detectability than that in the 2-day protocol.

100 Deals associated with [68Ga]Ga-Sa-DABI-4

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 1	CN	First Affiliated Hospital of Chongqing Medical University	21 May 2024

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