EGFR Mutation Targeting Molecular Probe for PET Imaging | NCT06641674

Studies
EGFR Mutation Targeting Molecular Probe for PET Imaging

NCT06641674

Sponsor

Peking University Cancer Hospital & Institute

Status

Not yet recruiting

Last Update Posted

Oct 15, 2024Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Cancer

Interventions

18F-LF13

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2024Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Oct 11, 2024

First Submission Date that Met QC Criteria

Oct 11, 2024

First Posted Date

Oct 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2024

Last Update Posted Date

Oct 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this project, investigators plan to develop a F-18 labeled molecular probe in order to detect the EGFR mutation tumor lessions in patients to identify patients benefiting fromTKIs treatment, and evaluate its efficacy in detecting EGFR Del 19 mutant lung cancer.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-LF13	Drug	18F-LF13 PET/CT: after intravenous injection of 1.85 - 3.7 MBq/kg body weight of quality-controlled 18F-LF13, a Siemens Biograph PET/CT scan will be applied within 0.5 h, and the scan range will be from the top of the head to 1/3 of the upper thigh, 2 h to 4 h delayed scanning can be added if necessary.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Standard Uptake Value Value	The standardized uptake value (SUV) of 18F-LF13 in EGFR mutation lesion measured by PET/CT	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female, aged 18-75 years old (including 18 and 75 years old), ECOG score 0 or 1.
Patients could understand and sign the informed consent form voluntarily with good compliance.
Patients with histologically or cytologically or clinically confirmed lung cancer with measurable disease.
Women had to be using an effective contraceptive method (effective contraceptive means sterilisation, intrauterine hormonal devices, condoms, contraceptives/pills, sexual abstinence, or partner's removal of the vas deferens) during the study and for 6 months after the study. Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period.
Predicted survival greater than 3 months;

Exclusion Criteria:

Severe hepatic or renal dysfunction;
Pregnant or nursing;
Known allergy to the investigational drug or its excipients in study;
Unable to comply with the PET/CT imaging procedures;
Claustrophobia or other psychiatric disorders;
Other conditions deemed unsuitable for participation in the trial;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Lung cancer patients or lung cancer patients treated with TKIs

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhi Yang	Contact	010-88196196		pekyz@163.com
Hua Zhu	Contact		010-88196495	zhuhuabch@pku.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Cancer Hospital		Beijing	Beijing Municipality	100142	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided