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Clinical Prospective Study of Gallium 68 ( 68GA)–Labeled Fibroblast-Activation Protein Inhibitor PET/CT in the Diagnosis of Biliary Tract Carcinoma
30 Pages Posted: 22 Nov 2022
More...Abstract
Background: Early and accurate diagnosis is crucial to managing biliary tract carcinoma (BTC). But18F-fluorodeoxyglucose (18F-FDG) PET/CT has deficiencies. Novel radiolabeled fibroblast activation protein (FAP) inhibitors, which present a promising alternative to 18F-FDG, allowed for the selective targeting of tumors.
Methods: A prospective study (NCT 05264688) was performed between January 2022 through July 2022. Fifty participants were scanned using 68Ga-FAPI and 18F-FDG PET/CT and acquired pathological tissue.We employed the Wilcoxon signed-rank test to compare the uptake of 68Ga-FAPI and 18F-FDG, and the McNemar test was used to compare the diagnostic efficacy between the two tracers. Spearman or Pearson correlation was used to assess the association between 68Ga-FAPI PET/CT and clinical indexes.
Findings: In total, 47 participants (mean age 59.09±10.98 [range 33–80 years]) were evaluated. The 68Ga-FAPI detection rate was greater than 18F-FDG in primary tumors (97.62% vs. 85.71%), nodal metastases (90.05% vs. 87.06%), distant metastases (100% vs. 83.67%). The uptake of 68Ga-FAPI was higher than 18F-FDG in primary lesions (intrahepatic cholangiocarcinoma: 18.95±7.47 vs. 11.86±0.70, p=0.001; extrahepatic cholangiocarcinoma:14.57±6.16 vs. 8.80±4.74, p=0.004), abdomen and pelvic cavity nodal metastases (6.91±6.56 vs. 3.94±2.83, p<0.001), distant metastases (pleural, peritoneum, omentum, and mesentery: 6.37±4.21 vs. 4.50±1.96, p=0.01; Bone: 12.15±6.43 vs. 7.51±4.54, p=0.008). There was a significant correlation between 68Ga-FAPI uptake and FAP expression (Spearman r=0.432, p=0.009), carcinoembryonic antigen (CEA) (Pearson r=0.364, p=0.012), and platelet (PLT) (Pearson r=0.35, p=0.016). Meanwhile, a significant relationship between 68Ga-FAPI metabolic tumor volume (MTV) and carbohydrate antigen199 (CA199) (Pearson r=0.436, p=0.002) was confirmed.
Interpretation: 68Ga-FAPI preceded 18F-FDG in diagnosing BTC to a certain extent. The correlation between 68Ga-FAPI PET/CT indexes and FAP expression, CEA, PLT, and CA199 were confirmed.
Trial Registration: This clinical trial was registered on clinicaltrails.gov (NCT 05264688)
Funding: Key Research and Development Program of Hubei Province (2021BCA114), Research Fund of the Health Commission of Hubei Province (WJ2021M255), Cancer research and translational platform project of Zhongnan Hospital of Wuhan University (ZLYNXM202004).
Declaration of Interest: All authors have no conflicts of interest or financial ties to disclose
Ethical Approval: This study was approved by the Clinical Research Ethics Committee of Zhongnan Hospital of Wuhan University. Before participating in this study, the participants must provide written informed consent.
Keywords: Fibroblast Activation Protein, FAPI, PET/CT, Biliary tract carcinoma
Suggested Citation: Suggested Citation