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

Overview

Basic Info

Drug Type

Diagnostic radiopharmaceuticals, Radionuclide Drug Conjugates (RDC)

Synonyms

68Ga-DOTA-NI-FAPI04

Target-

Mechanism-

Therapeutic Areas

NeoplasmsOther DiseasesSkin and Musculoskeletal Diseases

Active Indication

CarcinomaFibrosisBreast Cancer

Inactive Indication

Fibrosis, Liver

Originator Organization

First Affiliated Hospital Of Fujian Medical University

Active Organization

First Affiliated Hospital Of Fujian Medical University

University Hospital Heidelberg

Inactive Organization-

Drug Highest PhaseEarly Phase 1

First Approval Date-

Regulation-

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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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84

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

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SNMMI2024	Not Applicable	-	-	Deep Neural Network	slbzbkzyza(gxurkspobr) = ngqcfabwsa nwesitmght (aogvrxlcsf )	-	09 Jun 2024
SNMMI2024	Not Applicable	-	-	Deep Neural Network (Conventional PET)	slbzbkzyza(gxurkspobr) = ublngblgtj nwesitmght (aogvrxlcsf )	-	09 Jun 2024
SNMMI2023	Not Applicable	Colorectal Cancer	-	FDG68 FAPI 04 (FDG PET CT)	gmnfabfoyn(lfxpmiypgd) = ncfiuoilvd bkovqicxvl (gmonsbolyz ) View more	Positive	28 Aug 2023
SNMMI2023	Not Applicable	Neoplasms	-	18F-FDGTA-F2 (18F-FDG PET/CT)	sempebqrzn(nqfxqdolka) = gktkordxzb rynyqnubnl (qjgexblyss ) 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)	gqqzrvpnek(vcqwuyhxko) = aytyhqntff yjxfngwqof (ufxylrxeja )	-	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)	gqqzrvpnek(vcqwuyhxko) = pobmycbcnu yjxfngwqof (ufxylrxeja )	-	22 Sep 2022
SNMMI2022	Not Applicable	Gastrointestinal Neoplasms	-	68Ga-FAPI-04 PET/CT	rsmfntbnka(zkuipesvzo) = xawidmqyhk sgflojwjky (cipllemget )	-	08 Aug 2022
SNMMI2022	Not Applicable	Gastrointestinal Neoplasms	-	68Ga-FAPI-0418F-FDGPI-04 (18F-FDG PET/CT)	rsmfntbnka(zkuipesvzo) = smtajqnwfp sgflojwjky (cipllemget )	-	08 Aug 2022
EULAR2021	Not Applicable	Interstitial lung disease due to systemic disease Fibroblast Activation Protein (FAP)	21	68GA-FAPI-04 (SSc-ILD patients)	pnfqnetiwq(vaiwafdrfs) = ufksqpnavp udqnqabdyb (fgjogeyujh ) View more	-	02 Jun 2021