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Clinical Trial · NCT05411432
Clinical Study of 68Ga Labeled HER2 Affibody Analogues
Overview
The purpose of this study is to assess the dosimetric properties of the positron emission tomography (PET) imaging probe 68Ga labeled HER2 Affibody analogues and preliminarily evaluate its diagnosis value in patients with breast or gastric tumors.
Sponsor
Xijing Hospital
Phase
Early Phase 1
Contacts
Jing Wang, M.D, Ph.D (CONTACT)
wangjing@fmmu.edu.cn
86-29-84775449
ClinicalTrials.gov
NCT05411432Drug / Compound
FDG
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Glucose Transport
Ligand Class: Small Molecules
HER2 Affibody
Isotope(s):
GALLIUM-68
Radioisotope: Ga-68
Theranostic Role: PET Imaging
T1/2 (Half-Life): 68 minutes
Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
Range: N/A
Decay Daughters: Zn68 (Stable)
Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
Target(s):
- HER2
Ligand Class: Small Proteins and Antibody Fragments
Chelator: DOTA
Eligibility
Inclusion
- patients with breast or gastric cancers: diagnosed by MR and ready for surgery
Exclusion
- refuse or cannot endure surgery pregnant women
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