CancerEGFR-PETNCT06641674
EGFR Mutation Targeting Molecular Probe for PET Imaging
An observational study of Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer
- What is being tested?
- 18F-LF13
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung cancer patients or lung cancer patients treated with TKIs
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hua Zhu contact
China1 site
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Hua Zhu, 010-88196495, zhuhuabch@pku.edu.cn
About this study
Official title: Development and Clinical Translation of EGFR Mutation Targeting PET Probe
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.
- Conditions
- Cancer
- Being tested
- 18F-LF13
- Keywords
- PET imaging, EGFR mutation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-LF13Drug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Uptake Value Value
The standardized uptake value (SUV) of 18F-LF13 in EGFR mutation lesion measured by PET/CT
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Nov 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641674
- Sponsor's protocol ID
- 2024YJZ02
- Acronym
- EGFR-PET
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Translation of EGFR Mutation Targeting PET Probe
- ClinicalTrials.gov ID
- NCT06641674
- Acronym / sponsor ID
- EGFR-PET / 2024YJZ02
- Conditions
- Cancer
- Keywords
- PET imaging, EGFR mutation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients or lung cancer patients treated with TKIs
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-LF1318F-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. | Drug | – |
Primary outcome
Standard Uptake Value Value
Time frame: 1 year
The standardized uptake value (SUV) of 18F-LF13 in EGFR mutation lesion measured by PET/CT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Cancer
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hua Zhu contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhi Yang (010-88196196, pekyz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard Uptake Value Value (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.