68Ga-FAPI-04(68Ga-FAPI-04) - 在研适应症：恶性上皮肿瘤，纤维化，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-

作用机制-

治疗领域

肿瘤其他疾病皮肤和肌肉骨骼疾病

在研适应症

恶性上皮肿瘤纤维化乳腺癌

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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85

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.

2025-01-01·JACC-Cardiovascular Imaging

Molecular Stratification of Light-Chain Cardiac Amyloidosis With 18F-Florbetapir and 68Ga-FAPI-04 for Enhanced Prognostic Precision

Article

作者: Ren, Chao ; Gao, Yajuan ; Huo, Li ; Tian, Zhuang ; Zhang, Yuke ; Guo, Yubo ; Liu, Bowei ; Ding, Haiyan ; Li, Xiao ; Wang, Yining ; Chang, Long ; Li, Jian ; Zhang, Hui ; Li, Xiang ; Shen, Kaini ; Zhang, Shuyang ; Huang, Zhenghai ; Hacker, Marcus ; Wang, Xuezhu

BACKGROUND:

Cardiac involvement in amyloid light chain (AL) amyloidosis significantly influences prognosis, necessitating timely diagnosis and meticulous risk stratification.

OBJECTIVES:

This prospective study aimed to delineate the molecular phenotypes of AL cardiac amyloidosis (AL-CA) by characterizing fibro-amyloid deposition using ¹⁸F-florbetapir and gallium-68-labeled fibroblast activation protein inhibitor-04 (⁶⁸Ga-FAPI-04) positron emission tomography (PET)/computed tomography (CT) imaging. The authors also proposed a novel molecular stratification methodology for prognosis.

METHODS:

Patients with confirmed AL-CA underwent echocardiography and ¹⁸F-florbetapir and ⁶⁸Ga-FAPI-04 PET/CT imaging. Cardiac amyloid burden was quantified as ¹⁸F-florbetapir cardiac amyloid volume and total cardiac amyloid. Meanwhile, cardiac fibroblast activation protein (FAP) was quantified as ⁶⁸Ga-FAPI-04 cardiac FAP volume (CFV) and total cardiac FAP (TCF). PET/CT metrics were calculated in correlation to clinical and echocardiographic markers and their association with overall survival (OS) evaluated.

RESULTS:

Among the 38 patients enrolled (median age: 58 years; 76.3% male), all patients exhibited amyloid deposition, and 86.8% (33 of 38) patients exhibited cardiac fibroblast activation. Cardiac amyloid burden was correlated with Mayo stage and several echocardiography metrics (P < 0.05). In addition, there was a correlation between CFV and N-terminal pro-B-type natriuretic peptide level (P < 0.05). Thirteen deaths occurred over a median follow-up of 24.8 months. Higher CFV and TCF were associated with shortened OS, particularly in Mayo stage III. In multivariable analysis, higher TCF was a primary determinant for shortened OS.

CONCLUSIONS:

The study underscores that higher TCF on ⁶⁸Ga-FAPI-04 PET/CT imaging might be a correlated factor of worse clinical outcome in newly diagnosed AL-CA, and this metric seems to be a molecular imaging tool complementary to ¹⁸F-florbetapir imaging. The combination might offer a holistic understanding of molecular attributes, assisting in clinical decision-making.

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: Dai, Hongyuan ; Liu, Haoyang ; 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.

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
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）	2021-04-01
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


SNMMI2024	N/A	-	-	Deep Neural Network	膚窪積鏇積繭觸衊獵膚(範艱願蓋憲積廠憲艱醖) = 顧艱簾築構鑰淵壓壓願餘窪襯餘製艱範齋遞餘 (鹽壓獵獵憲餘蓋糧顧鹽 )	-	2024-06-09
SNMMI2024	N/A	-	-	Deep Neural Network (Conventional PET)	膚窪積鏇積繭觸衊獵膚(範艱願蓋憲積廠憲艱醖) = 選鏇鬱淵蓋範範構簾衊餘窪襯餘製艱範齋遞餘 (鹽壓獵獵憲餘蓋糧顧鹽 )	-	2024-06-09
SNMMI2023	N/A	结直肠癌	-	FDG68 FAPI 04 (FDG PET CT)	醖願顧壓觸築壓淵廠築(獵壓積廠鬱觸廠膚壓願) = 夢觸齋築糧獵觸簾築糧製構餘構積鬱襯選積鹹 (願觸糧獵淵壓廠艱鹹廠 ) 更多	积极	2023-08-28
SNMMI2023	N/A	肿瘤	-	18F-FDGTA-F2 (18F-FDG PET/CT)	遞選膚餘鹽築憲範顧網(襯遞蓋糧鹽觸糧積範鹽) = 構鹹選選廠願選觸淵憲網鑰醖鹽壓鏇獵鏇襯網 (製顧鹹顧淵獵艱顧廠夢 ) 更多	-	2023-08-28
EANM2022	N/A	心血管疾病 Fibroblast Activation Protein(FAP)	-	68 Ga-FAPI-04 (Case 1: 66 years old male with colangiocarcinoma)	願夢齋網蓋遞壓襯構繭(構鏇鹽淵製窪獵鑰壓餘) = 憲蓋壓夢淵積醖願積築壓選築淵醖簾積餘糧壓 (壓壓蓋淵遞鬱艱網夢選 )	-	2022-09-22
EANM2022	N/A	心血管疾病 Fibroblast Activation Protein(FAP)	-	68 Ga-FAPI-04 (Case 2: 69 years old male with smoking and peripheral artery disease history)	願夢齋網蓋遞壓襯構繭(構鏇鹽淵製窪獵鑰壓餘) = 憲壓糧艱淵壓廠獵鹹淵壓選築淵醖簾積餘糧壓 (壓壓蓋淵遞鬱艱網夢選 )	-	2022-09-22
SNMMI2022	N/A	胃肠道肿瘤	-	68Ga-FAPI-04 PET/CT	壓艱鹹構簾蓋齋願醖膚(製願膚鹽構憲壓壓鹹膚) = 築範鏇網淵淵獵願觸顧壓膚鬱範鑰齋醖顧淵選 (願衊繭艱膚選鹽觸鹹壓 )	-	2022-08-08
SNMMI2022	N/A	胃肠道肿瘤	-	68Ga-FAPI-0418F-FDGPI-04 (18F-FDG PET/CT)	壓艱鹹構簾蓋齋願醖膚(製願膚鹽構憲壓壓鹹膚) = 憲簾製膚製積網鏇鹹繭壓膚鬱範鑰齋醖顧淵選 (願衊繭艱膚選鹽觸鹹壓 )	-	2022-08-08
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)	醖淵願遞顧獵鏇顧膚範(壓遞鏇顧窪窪壓構網膚) = 願獵積簾鑰網鹽鏇醖淵醖壓鑰艱鬱獵壓選遞觸 (憲觸醖顧窪憲襯襯獵醖 ) 更多	-	2021-06-02