Delving into the Latest Updates on 68Ga-FAPI-04 with Synapse

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

NCT06455735

/ RecruitingEarly Phase 1IIT

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.

Start Date01 Mar 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

100 Clinical Results associated with 68Ga-FAPI-04

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100 Translational Medicine associated with 68Ga-FAPI-04

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

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81

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

01 Jan 2025·CLINICAL NUCLEAR MEDICINE

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

Article

Author: 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.

01 Jan 2025·JACC-Cardiovascular Imaging

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

Article

Author: Ren, Chao ; Gao, Yajuan ; Tian, Zhuang ; Huo, Li ; Zhang, Yuke ; Guo, Yubo ; Liu, Bowei ; Ding, Haiyan ; Li, Xiao ; Wang, Yining ; Chang, Long ; Li, Jian ; Zhang, Hui ; Shen, Kaini ; Li, Xiang ; 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.

01 Oct 2024·CLINICAL NUCLEAR MEDICINE

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

Article

Author: 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.

100 Deals associated with 68Ga-FAPI-04

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Carcinoma	Phase 1	CN	First Affiliated Hospital Of Fujian Medical University	01 Apr 2024
Fibrosis	Phase 1	CN	First Affiliated Hospital Of Fujian Medical University	01 Apr 2021
Fibrosis, Liver	Phase 1	CN	First Affiliated Hospital Of Fujian Medical University	01 Sep 2020
Breast Cancer	Preclinical	DE	University Hospital Heidelberg	06 Apr 2018

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SNMMI2024	Not Applicable	-	-	Deep Neural Network	cspesevmea(vqxtohqiii) = rkidhvjsdu acvgyksfwr (awndrlcxhu )	-	09 Jun 2024
SNMMI2024	Not Applicable	-	-	Deep Neural Network (Conventional PET)	cspesevmea(vqxtohqiii) = fwvkdtigvm acvgyksfwr (awndrlcxhu )	-	09 Jun 2024
SNMMI2023	Not Applicable	Colorectal Cancer	-	FDG68 FAPI 04 (FDG PET CT)	aiilfadgpt(ozyoterybl) = bnaaliqrtw vkyioaqdjc (trojvspgep ) View more	Positive	28 Aug 2023
SNMMI2023	Not Applicable	Neoplasms	-	18F-FDGTA-F2 (18F-FDG PET/CT)	uienyxwbmm(dpgwzegatk) = bvnbldzfni zxiqyoakyj (simfkqtdih ) View more	-	28 Aug 2023
EANM2022	Not Applicable	Cardiovascular Diseases Fibroblast Activation Protein(FAP)	-	68 Ga-FAPI-04 (Case 1: 66 years old male with colangiocarcinoma)	vxscxyzvzw(jypzuirgka) = muznoqfbrj wqjwxylxny (zbtyuzzqvh )	-	22 Sep 2022
EANM2022	Not Applicable	Cardiovascular Diseases Fibroblast Activation Protein(FAP)	-	68 Ga-FAPI-04 (Case 2: 69 years old male with smoking and peripheral artery disease history)	vxscxyzvzw(jypzuirgka) = pmflllbkis wqjwxylxny (zbtyuzzqvh )	-	22 Sep 2022
SNMMI2022	Not Applicable	Gastrointestinal Neoplasms	-	68Ga-FAPI-04 PET/CT	xzkbxfscay(bquwugrcaa) = rlpuuivrcp shjjgxcubi (xorqqueyqt )	-	08 Aug 2022
SNMMI2022	Not Applicable	Gastrointestinal Neoplasms	-	68Ga-FAPI-0418F-FDGPI-04 (18F-FDG PET/CT)	xzkbxfscay(bquwugrcaa) = pwowckdaau shjjgxcubi (xorqqueyqt )	-	08 Aug 2022
EULAR2021	Not Applicable	Interstitial lung disease due to systemic disease Fibroblast Activation Protein (FAP)	21	68GA-FAPI-04 (SSc-ILD patients)	cbvyrtxovc(xmlvaybxap) = qbkeyivles himmrvihzk (yawwdlgeey ) View more	-	02 Jun 2021