Radioactive Labeled Compound for Noninvasive EGFR Mutation Detection

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Solution Overview

Problem

Current methods for detecting secondary mutations of the epidermal growth factor receptor (EGFR) in lung cancer are invasive and lack noninvasive alternatives, leading to challenges in monitoring resistance to EGFR-TKI treatments.

Innovation Solution

A radioactive labeled compound with a pyrido[3,4-d]pyrimidine skeleton is developed, allowing for noninvasive detection of secondary EGFR mutations through nuclear medicine diagnostic imaging, specifically distinguishing between L858R and T790M mutations using PET imaging.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If genetic tests are performed using cancer tissue collected by biopsy, then accurate detection of EGFR mutation status is achieved, but invasive procedures cause physical burden and various risks to patients

Engineering Contradiction:
Improvedetection accuracy of EGFR mutationVSAvoidphysical burden and risks from invasive biopsy
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical invasive biopsy system with a non-invasive nuclear medicine imaging system. The radioactive labeled compound (1) is administered to patients and accumulates in EGFR-expressing tissues, allowing mutation status detection through external imaging without physical tissue sampling. This substitution eliminates the harmful effects of invasive procedures while maintaining diagnostic capability.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces a radioactive labeled compound (1) as an intermediary substance that mediates between the detection system and the target tissue. This compound specifically binds to EGFR and carries a radioactive label, serving as a bridge that enables non-invasive detection of EGFR mutation status by translating molecular-level information into detectable radiation signals.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If repeated genetic tests are conducted to monitor secondary mutations during EGFR-TKI treatment, then resistance development can be detected, but repeated invasive biopsies increase patient burden and risk

Engineering Contradiction:
Improvemonitoring accuracy for resistance detectionVSAvoidtreatment interruption and patient burden from repeated procedures
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent replaces repeated invasive biopsy procedures with non-invasive nuclear medicine imaging for longitudinal monitoring. The radioactive labeled compound (1) can be administered multiple times to track changes in EGFR mutation status during EGFR-TKI treatment, enabling detection of secondary mutations and resistance development without subjecting patients to repeated physical trauma and treatment interruptions.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Loss of information

If conventional imaging methods are used for cancer diagnosis, then general tumor detection is achieved, but specific detection of EGFR mutation status and secondary mutations is not possible

Engineering Contradiction:
Improvedetection of specific molecular informationVSAvoidcomplexity of molecular-specific imaging system
Core Design Contradiction:
Loss of informationVSDevice complexity

Solution Approach 1:

The patent uses a radioactive labeled compound (1) as a molecular intermediary that specifically targets EGFR. This compound carries both the molecular recognition element (pyrido[3,4-d]pyrimidine core structure that binds to EGFR) and the detection element (radioactive label), enabling conventional imaging systems to visualize specific molecular information about EGFR mutation status without requiring complex new imaging infrastructure.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the detection parameter from general anatomical imaging to molecular-specific functional imaging. By incorporating a radioactive label into the EGFR-targeting compound, the system transforms conventional imaging capabilities into a tool that can detect specific molecular parameters such as EGFR expression levels and mutation status, providing information that cannot be obtained through structural imaging alone.

Inventive Principle:
Principle #35Parameter changes

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enables the noninvasive evaluation of EGFR mutation status and treatment efficacy, facilitating the monitoring of resistance development and optimizing EGFR-TKI therapy in lung cancer patients.

Implementation Method 1

X 1 is a radioactive halogen atom

Methodology Applied
Scientific EffectRadioactive decay: Radioactive Decay

Implementation Method 2

specifically distinguishing between L858R and T790M mutations using PET imaging

Methodology Applied
Scientific EffectPET imaging:

Data Source

PatentEP3112365B1Nuclear medicine diagnostic imaging agent
Publication Date: 2018.09.26 ARKRAY INC
  • EP3112365B1 patent drawingFigure 1~2
  • EP3112365B1 patent drawingFigure 3~4
  • EP3112365B1 patent drawingFigure 5~6

AI summary

Provided is a radioactive labeled compound that can detect a secondary mutation of an epidermal growth factor receptor and which is a compound represented by Formula (1) described below or a pharmaceutically acceptable salt thereof. In Formula (1), L1 is an alkanediyl group having 1 to 5 carbon atoms or an alkenediyl carbonyl group having 3 to 8 carbon atoms, R1 is a radioactive halogen atom, or 5- to 7-membered monocyclic nitrogen-containing heterocycloalkyl that may have one substituent, R2 is a 6- to 8-membered aryl group or nitrogen-containing heteroaryl group with one substituent, R1 or R2 contains a radioactive halogen atom or a radioactive carbon atom (11C), and Y is -NH- or -O-.