68Ga-FAPI-04(68Ga-FAPI-04) - 药物靶点：FAP_在研适应症：恶性上皮肿瘤，乳腺癌_专利_临床

概要

基本信息

药物类型

诊断用放射药物、核素偶联药物

别名

68Ga-DOTA-NI-FAPI04

靶点

FAP

作用机制

FAP拮抗剂(成纤维细胞激活蛋白α拮抗剂)、PET imaging(正电子发射断层成像术增强剂)

治疗领域

肿瘤皮肤和肌肉骨骼疾病

在研适应症

恶性上皮肿瘤乳腺癌

非在研适应症

肝纤维化

原研机构

福建医科大学附属第一医院（福建省皮肤病性病防治院、福建省皮肤病性病防治研究所）

在研机构

福建医科大学附属第一医院（福建省皮肤病性病防治院、福建省皮肤病性病防治研究所）

University Hospital Heidelberg

非在研机构-

最高研发阶段早期临床1期

首次获批日期-

最高研发阶段(中国)早期临床1期

特殊审评-

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关联

6

项与 68Ga-FAPI-04 相关的临床试验

NCT06455761 / Recruiting早期临床1期IIT

68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer

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.

开始日期2024-04-01

申办/合作机构

福建医科大学附属第一医院（福建省皮肤病性病防治院、福建省皮肤病性病防治研究所）

NCT06455735 / Recruiting早期临床1期IIT

68Ga-JH04 PET/CT in Patients With Various Types of Cancer

As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-JH04 is promising as an excellent imaging agent for various cancers. In this study, we observed the diagnostic performance of 68Ga-JH04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.

开始日期2024-03-01

申办/合作机构

福建医科大学附属第一医院（福建省皮肤病性病防治院、福建省皮肤病性病防治研究所）

NCT05999227 / RecruitingN/AIIT

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

开始日期2023-06-20

申办/合作机构

华中科技大学同济医学院附属协和医院

100 项与 68Ga-FAPI-04 相关的临床结果

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100 项与 68Ga-FAPI-04 相关的转化医学

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100 项与 68Ga-FAPI-04 相关的专利（医药）

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77

项与 68Ga-FAPI-04 相关的文献（医药）

2025-01-01·CLINICAL NUCLEAR MEDICINE

68Ga-FAPI-04 PET/CT Imaging in a Patient With Psoriatic Arthritis

Article

作者: Yang, Lixiang ; Tian, Rong ; Jiang, Lisha ; Li, Qianrui ; Zhang, Zitong

Abstract:

We described the findings of 68Ga-FAPI-04 PET/CT of psoriatic arthritis in a 56-year-old man. Intense FAPI uptake was observed alongside the spine and in the joints of bilateral feet and the right hip. 68Ga-FAPI PET/CT is potentially valuable for the evaluation of join involvement and disease activity in patients with psoriasis.

2024-10-01·CLINICAL NUCLEAR MEDICINE

Comparison of 68Ga-FAPI-04 and 18F-FDG PET/CT in Fumarate Hydratase-Deficient Renal Cell Carcinoma

Article

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

Purpose:

Fumarate 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 Methods:

Patients 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.

Results:

Eleven 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).

Conclusions:

18F-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.

2024-10-01·CLINICAL NUCLEAR MEDICINE

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

Article

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

Aim:

This 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.

Methods:

The 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.

Results:

The 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.

Conclusions:

68Ga-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.

100 项与 68Ga-FAPI-04 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
恶性上皮肿瘤	临床1期	中国	福建医科大学附属第一医院（福建省皮肤病性病防治院、福建省皮肤病性病防治研究所）	2024-04-01
肝纤维化	临床1期	中国	福建医科大学附属第一医院（福建省皮肤病性病防治院、福建省皮肤病性病防治研究所）	2020-09-01
乳腺癌	临床前	德国	University Hospital Heidelberg	2018-04-06

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EANM2022	N/A	心血管疾病 Fibroblast Activation Protein(FAP)	-	68 Ga-FAPI-04 (Case 1: 66 years old male with colangiocarcinoma)	壓鑰築網鹽獵遞築餘蓋(艱積構壓膚淵遞齋膚衊) = 鹹觸鏇選簾夢顧糧鹹憲鬱衊鑰鏇齋醖築鬱膚衊 (網壓繭範繭襯鹽衊鑰壓 )	-	2022-09-22
				68 Ga-FAPI-04 (Case 2: 69 years old male with smoking and peripheral artery disease history)	壓鑰築網鹽獵遞築餘蓋(艱積構壓膚淵遞齋膚衊) = 選憲廠簾鹽壓遞淵艱淵鬱衊鑰鏇齋醖築鬱膚衊 (網壓繭範繭襯鹽衊鑰壓 )
SNMMI2022	N/A	胃肠道肿瘤	-	68Ga-FAPI-04 PET/CT	願鬱遞醖淵艱夢襯繭膚(齋願襯網齋製構膚鬱淵) = 網齋鑰獵鹹糧壓壓鏇夢選鏇衊醖願窪範遞衊鏇 (製醖餘餘鬱製壓顧淵繭 )	-	2022-08-08
				68Ga-FAPI-0418F-FDGPI-04 (18F-FDG PET/CT)	願鬱遞醖淵艱夢襯繭膚(齋願襯網齋製構膚鬱淵) = 選願繭網膚鹽範憲獵網選鏇衊醖願窪範遞衊鏇 (製醖餘餘鬱製壓顧淵繭 )
EULAR2021	N/A	系统性硬化相关的间质性肺病 Fibroblast Activation Protein (FAP)	21	68GA-FAPI-04 (SSc-ILD patients)	積蓋獵製願鏇簾網廠繭(壓糧鑰獵蓋鏇膚鹹築糧) = 築鏇獵構鬱憲製鏇糧網壓顧齋齋窪襯築構鏇齋 (鬱齋蓋顧壓糧壓膚夢獵 ) 更多	-	2021-06-02