As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. In this study, we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.

Start Date01 Apr 2024

Sponsor / Collaborator

First Affiliated Hospital Of Fujian Medical University

NCT05999227 / RecruitingNot ApplicableIIT

68Ga-FAPI-04 PET Imaging in Early Response Evaluation of Rectal Cancer Patients Treated With Immunotherapy: A Single-center Clinical Study

This study is a prospective monocentric study aimed to explore the value of 68Ga-FAPI-04 PET imaging in early response evaluation of rectal cancer patients treated with immunotherapy. Patients with histopathologically confirmed diagnosis of rectal cancer will be recruited and undergo 68Ga-FAPI-04 and 18F-FDG PET imaging before treatment and after short-course radiotherapy and two cycles of neoadjuvant chemotherapy plus immunotherapy. The two imaging intervals will be completed two days apart. The efficacy of 68Ga-FAPI-04 in early response evaluation will be compared with the general imaging agent 18F-FDG. The general information, clinical data, mpMRI data, 68Ga-FAPI-04 and 18F-FDG PET imaging results and other imaging data of the patients will be collected. The histopathology of the biopsy or surgical specimen after 2 cycles of therapy and follow-up data will be taken as evaluation references. This study plans to set the sample size as 20 cases

Start Date20 Jun 2023

Sponsor / Collaborator

Wuhan Xiehe Hospital Tower

NCT04831034 / RecruitingEarly Phase 1IIT

68Ga-DOTA/NOTA-FAPI PET/CT in Patients With Various Fibrotic Disease

To evaluate the potential value of 68Ga-FAPI-04 positron emission tomography/ computed tomography (PET/CT) for the diagnosis and prognosis in fibrotic disease

Start Date01 Apr 2021

Sponsor / Collaborator

First Affiliated Hospital Of Fujian Medical University

100 Clinical Results associated with 68Ga-FAPI-04

100 Translational Medicine associated with 68Ga-FAPI-04

100 Patents (Medical) associated with 68Ga-FAPI-04

Literatures (Medical) associated with 68Ga-FAPI-04

01 Oct 2024·Clinical Nuclear Medicine

A Prospective and Single-Center Study

Article

Author: Dai, Hongyuan ; Qi, Mengfang ; Huang, Rui ; Su, Minggang ; Liu, Haoyang ; Zeng, Hao ; Huang, Shuhui

PurposeFumarate hydratase-deficient renal cell cancer (FHRCC) is a rare and aggressive form of renal cell carcinoma. The diagnostic value of 68Ga-FAPI PET/CT for FHRCC remains unexplored. Therefore, we compared the potential value of 68Ga-FAPI-04 and 18F-FDG PET/CT in FHRCC.Patients and MethodsPatients with FHRCC underwent 68Ga-FAPI-04 and 18F-FDG PET/CT from May 2022 to December 2023. The SUVmax and tumor-to-liver ratio (TLR) of both tracers were compared using the Wilcoxon signed rank test.ResultsEleven patients with 83 lesions were enrolled. The rate of 18F-FDG PET/CT in detecting lesions was higher than that of 68Ga-FAPI-04 PET/CT: primary tumors: 75.0% (6/8) versus 50.0% (4/8); lymph nodes: 94.9% (37/39) versus 89.7% (35/39); and bone lesions: 100.0% (21/21) versus 90.5% (19/21). The median SUVmax of primary and metastatic lesions on 18F-FDG PET/CT was comparable to 68Ga-FAPI-04 PET/CT in semiquantitative analysis (primary lesions: 13.86 vs 16.35, P = 1.000; lymph nodes: 10.04 vs 9.33, P = 0.517; bone lesions: 13.49 vs 9.84, P = 0.107; visceral lesions: 8.54 vs 4.20, P = 0.056). However, the median TLRs of primary and metastatic lesions on 68Ga-FAPI-04 PET/CT were higher than that of 18F-FDG PET/CT (primary lesions: 30.44 vs 5.41, P = 0.010; lymph nodes: 17.71 vs 3.95, P = 0.000; bone lesions: 15.94 vs 5.21, P = 0.000; visceral lesions: 9.26 vs 3.44, P = 0.003).Conclusions18F-FDG PET/CT detected more primary and metastatic FHRCC lesions than 68Ga-FAPI-04 PET/CT. However, the higher TLR in FHRCC on 68Ga-FAPI-04 PET/CT may indicate therapeutic potential in targeting fibroblast activation protein in FHRCC.

01 Oct 2024·Clinical Nuclear Medicine

The Contribution of 68Ga-FAPI-04 PET/CT to Staging and Prognosis in Gastric Cancer

Article

Author: Erol Fenercioğlu, Özge ; Beyhan, Ediz ; Arslan, Esra ; Alçin, Göksel ; Çermik, Tevfik Fikret ; Şahin, Rahime ; Aksoy, Tamer ; Ergül, Nurhan

AimThis study aimed to compare the diagnostic capabilities of 18F-FDG PET/CT and 68Ga-FAPI-04 PET/CT imaging in staging gastric carcinoma, exploring the impact of 68Ga-FAPI-04 PET/CT on treatment planning and its prognostic significance.MethodsThe research included 31 patients undergoing staging for gastric cancer, who received both 18F-FDG PET/CT and 68Ga-FAPI-04 PET/CT scans. We compared the SUVmax and SUVmean of the primary tumor and lymph nodes, the count of organ metastases, tumor-to-background ratios, and overall staging accuracy. Additionally, the study evaluated radiological progression-free survival and overall survival rates.ResultsThe 68Ga-FAPI-04 PET/CT demonstrated superior efficacy in identifying the primary tumor compared with 18F-FDG PET/CT, particularly in cases of poorly cohesive, signet-ring cell, and mucinous subtypes, with detection rates of 96.7% versus 77.4% (P = 0.006 and P = 0.008, respectively). Analysis of lymph nodes showed a significantly higher detection of positive nodes with 68Ga-FAPI-04 (P = 0.026), although no significant differences were observed in SUVmax and tumor-to-background ratio on a patient basis (P > 0.05). SUVmax and tumor-to-background ratios for peritoneal involvement were notably higher with 68Ga-FAPI-04 PET/CT compared with 18F-FDG PET/CT (P = 0.04 for both). No significant differences were found in the detection of organ metastases and disease stage between the 2 imaging modalities (P > 0.05). Primary tumor uptake did not significantly impact radiological progression-free survival or overall survival in either modality.Conclusions68Ga-FAPI-04 PET/CT imaging surpasses 18F-FDG PET/CT in detecting the primary tumor, especially in poorly cohesive and signet-ring cell gastric cancer types, and offers improved accuracy in disease staging. This indicates its potential to enhance treatment management and prognostic assessment in gastric cancer patients.

01 Jul 2024·Quantitative Imaging in Medicine and Surgery

Heterogeneity of fibroblast activation protein expression in the microenvironment of an intracranial tumor cohort: head-to-head comparison of gallium-68 FAP inhibitor-04 (68Ga-FAPi-04) and fluoride-18 fluoroethyl-L-tyrosine (18F-FET) in positron emission tomography-computed tomography imaging

Article

Author: Xu, Hongzhi ; Guan, Yihui ; Fu, Pengfei ; Chen, Mingyu ; Li, Ming ; Hua, Tao ; Zhou, Weiyan ; Zhao, Wen ; Zuo, Chuantao

BackgroundCancer-associated fibroblasts (CAFs) within the tumor microenvironment (TME) can interact with tumor parenchymal cells to promote tumor growth and migration. Fibroblast activation protein (FAP) expressed by CAFs can be targeted with positron emission tomography (PET) tracers, but studies on FAP expression patterns in intracranial tumors remain scarce. We aimed to evaluate FAP expression patterns in intracranial tumors with gallium-68 FAP inhibitor-04 (⁶⁸Ga-FAPi-04) and immunohistochemical staining and to observe the interactions between CAFs and tumor cells with a head-to-head comparison of ⁶⁸Ga-FAPi-04 and fluoride-18 fluoroethyl-L-tyrosine (¹⁸F-FET) for PET quantification analysis.MethodsWe prospectively enrolled 22 adult patients with intracranial mass lesions. ⁶⁸Ga-FAPi-04 and ¹⁸F-FET PET-computed tomography (PET/CT) brain imaging were applied before surgery. Maximal tumor-to-brain ratio (TBRmax), metabolic tumor volume (MTV), and total lesion tracer uptake (TLU) was obtained, and different thresholds were used for ⁶⁸Ga-FAPi-04-positive lesion delineation owing to the lack of relevant guidelines. The MTV and TLU ratios of both tracers were calculated. Linear regression was applied to observe the differential efficacy of semiquantitative PET parameters.ResultsA total of 22 patients with a mean age of 50±13 years (range, 27-69 years) were enrolled. Heterogeneous patterns of ⁶⁸Ga-FAPi-04 uptake [median of maximal standardized uptake value (SUVmax) =3.8; range, 0.1-19.1] were found. More malignant tumors, including brain metastasis, glioblastoma, and medulloblastoma, generally exhibited more significant ⁶⁸Ga-FAPi-04 uptake than did the less malignant tumors, while the SUVmax and TBRmax exhibited nonsignificant differences across three intracranial lesion groups of primary brain tumor, brain metastasis, and noncancerous disease (SUVmax: P=0.092; TBRmax: P=0.189). Immunohistochemistry staining showed different stromal FAP expression status in various intracranial lesions. In 15 patients with positive ⁶⁸Ga-FAPi-04 intracranial tumor uptake, the MTV_FAPi:MTV_FET ratio had differential efficacy in various types of intracranial tumors [95% confidence interval (CI): 0.572-7.712; P=0.027], and further quantification analyses confirmed the differential ability of the MTV_FAPi:MTV_FET ratio (95% CI: -0.045 to 11.013, P=0.052; 95% CI: 0.044-17.903, P=0.049; 95% CI: -1.131 to 30.596, P=0.065) with different isocontour volumetric thresholds.ConclusionsThis head-to-head study demonstrated heterogeneous FAP expression in intracranial tumors. The FAP expression volume percentage in tumor parenchyma may therefore offer benefit with respect to differentiating between intracranial tumor types.

100 Deals associated with 68Ga-FAPI-04

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Indication	Highest Phase	Country/Location	Organization	Date
Fibrosis, Liver	Phase 2	CN	First Affiliated Hospital Of Fujian Medical University	01 Sep 2020
Neoplasms	Phase 1	CN	First Affiliated Hospital Of Fujian Medical University	01 Apr 2024
Breast Cancer	Preclinical	DE	University Hospital Heidelberg	06 Apr 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2021	Not Applicable	Interstitial lung disease due to systemic disease Fibroblast Activation Protein (FAP)	21	68GA-FAPI-04	glfmxovejk(jswvoczfqy) = rcxdspenvb mebfjnlysa (ysjcjvfyit ) View more	-	02 Jun 2021

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