Non-Small Cell Lung Cancer NSCLCPhase 3NCT06416852
Clinical Study of 18F-Alfatide Injection PET/CT
A Phase 3 study testing 18F-Alfatide Injection and 18F-FDG Injection in people with Non-Small Cell Lung Cancer NSCLC, run by Yantai LNC Biotechnology Singapore PTE. LTD. at 1 site in China.
Trial summary
This is a multicenter, open, non-inferiority Phase III clinical study to evaluate the efficacy of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT in the diagnosis of lymph node metastasis in non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer NSCLC
- What is being tested?
- 18F-Alfatide Injection and 18F-FDG Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteChina
- Study dates
- Aug 2024to Dec 2026
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects understand the clinical trial procedure and sign the informed consent in person;
- Patients with non-small cell lung cancer confirmed or highly suspected by investigators based on prior history, imaging, histopathology, and/or cytology, suspected lymph node metastasis and proposed radical surgery and lymph node dissection;
- Over 18 years old (including 18 years old);
- ECOG function status score 0~1 points ;
- Expected survival \> 3 months.
Who cannot join
- Known allergic history to 18F-Alfatide Injection and 18F-FDG injection or its excipients;
- Patients who cannot tolerate intravenous drug administration (such as needle fainting and blood fainting history);
- Patients who are not suitable for PET or cannot complete PET or other imaging tests due to special reasons, including claustrophobia and radiophobia;
- Workers who need to be exposed to radioactive conditions for a long time;
- Patients with renal insufficiency were defined as the standard endogenous creatinine clearance (Ccr) estimated by the Cockcroft-Gault formula \<60 ml/min, Ccr(ml/min)=[(140-age)× body weight (kg)]/[72×Scr(mg/dl)], and the calculated result for females was 0.85;
- Fasting blood glucose level more than 7.0 mmol/L;
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- There are serious infections that cannot be controlled before screening;
- Any serious disease that cannot be controlled, such as severe heart dysfunction (such as unstable angina pectoris, myocardial infarction, heart failure, etc.), a large number of pleural effusion patients, patients with mental illness, etc.;
- Previously diagnosed with other malignant tumors, except in the following cases:
- Adequately treated basal or squamous cell carcinoma (requiring adequate wound healing prior to enrollment in the study);
- Carcinoma in situ of cervical or breast cancer with curative treatment and no signs of recurrence for at least 3 years prior to the study;
- The primary malignancy has been completely removed and in complete remission for ≥5 years.
- Participants who had participated in clinical trials of radiopharmaceuticals within 1 year before screening;
- Participating in other interventional clinical trials within 1 month before screening;
- Poor general condition, heart, lung, liver, kidney, brain and other vital organs can not tolerate surgery;
- Those who had a birth plan during the trial and within 1 year after the completion of the trial, or the subjects and their spouses did not agree to take strict contraceptive measures during the trial and within 6 months after the completion of the trial (using condoms, contraceptive sponges, contraceptive gels, contraceptive membranes, intrauterine devices, oral or injectable contraceptives, subcutaneous implants, etc.);
- Pregnant or lactating female subjects;
- Subjects with poor compliance or other factors deemed unsuitable for participation in the study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Open, Non-inferiority Phase III Clinical Study to Evaluate the Efficacy of 18F-Alfatide Injection PET/CT Compared With 18F-FDG PET/CT in the Diagnosis of Lymph Node Metastasis in Non-small Cell Lung Cancer
This is a multicenter, open, non-inferiority Phase III clinical study to evaluate the efficacy of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT in the diagnosis of lymph node metastasis in non-small cell lung cancer.
This trial will include 428 patients with non-small cell lung cancer confirmed by imaging, histopathology and/or cytology or highly suspected by investigators, suspected lymph node metastasis and proposed radical surgery and lymph node dissection. Eligible subjects will receive 18F-Alfatide Injection PET/CT and 18F-FDG PET/CT scans within 1 week. Subjects will undergo relevant security checks before and after each scan. The subjects underwent radical surgery and lymph node dissection within 2 weeks of completing both scans, and the obtained lymph nodes were pathologically examined as the gold standard to compare the diagnostic efficacy of 18F-Alfatide versus 18F-FDG for lymph node metastasis.
- Conditions
- Non-Small Cell Lung Cancer NSCLC
- Being tested
- 18F-Alfatide Injection, 18F-FDG Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Alfatide InjectionDrug
A single dose of (0.1~0.15）±0.015 mCi/kg IV injection of 18F-Alfatide. The patients will be intravenously injected with 18F-Alfatide Injection and undergo PET/CT scan at 60 min±10 min after the injection.
18F-FDG InjectionDrug
A single dose of 5～10mCi IV injection of 18F-FDG. The patients will be intravenously injected with 18F-FDG Injection and undergo PET/CT scan at 40 min±10 min after the injection.
| Study group | Role | What they receive |
|---|---|---|
| 18F-Alfatide and 18F-FDG Injection | Experimental | The study is designed as a self-controlled trial, in which participants will be injected and scanned with two drugs. Receives: Drug: 18F-Alfatide Injection; Drug: 18F-FDG Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity evaluation of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT
To evaluate the sensitivity and specificity of 18F-Alfatide Injection PET/CT in the diagnosis of lymph node metastasis in non-small cell lung cancer compared with 18F-FDG PET/CT.All subjects in this study underwent 18F-Alfatide PET-CT and 18F-FDG PET-CT examination within one week, radical surgery and lymph node dissection within two weeks after the completion of the two scanning images, and pathological examination of the obtained lymph nodes was used as the gold standard.
Measured: Through study completion, assessed up to 2 years
Secondary outcomes (2)
Accuracy, positive predictive value and negative predictive value evaluation of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT
To evaluate the accuracy, positive predictive value and negative predictive value of 18F-Alfatide Injection PET/CT in the diagnosis of lymph node metastasis in non-small cell lung cancer compared with 18F-FDG PET/CT.All subjects in this study underwent 18F-Alfatide PET-CT and 18F-FDG PET-CT examination within one week, radical surgery and lymph node dissection within two weeks after the completion of the two scanning images, and pathological examination of the obtained lymph nodes was used as the gold standard
Measured: Through study completion, assessed up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To evaluate the safety of 18F-Alfatide Injection PET/CT in the diagnosis of lymph node metastasis in non-small cell lung cancer compared with 18F-FDG PET/CT.The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
Measured: Through study completion, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study startAug 2024 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer NSCLCStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yantai LNC Biotechnology Singapore PTE. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416852
- Sponsor's protocol ID
- 18F-Alfatide-003
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 16 May 2024
- Results posted
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open, Non-inferiority Phase III Clinical Study to Evaluate the Efficacy of 18F-Alfatide Injection PET/CT Compared With 18F-FDG PET/CT in the Diagnosis of Lymph Node Metastasis in Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06416852
- Acronym / sponsor ID
- 18F-Alfatide-003
- Conditions
- Non-Small Cell Lung Cancer NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- Yantai LNC Biotechnology Singapore PTE. LTD.Industry (pharma, biotech, devices)
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 May 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.
This is a multicenter, open, non-inferiority Phase III clinical study to evaluate the efficacy of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT in the diagnosis of lymph node metastasis in non-small cell lung cancer.
This trial will include 428 patients with non-small cell lung cancer confirmed by imaging, histopathology and/or cytology or highly suspected by investigators, suspected lymph node metastasis and proposed radical surgery and lymph node dissection. Eligible subjects will receive 18F-Alfatide Injection PET/CT and 18F-FDG PET/CT scans within 1 week. Subjects will undergo relevant security checks before and after each scan. The subjects underwent radical surgery and lymph node dissection within 2 weeks of completing both scans, and the obtained lymph nodes were pathologically examined as the gold standard to compare the diagnostic efficacy of 18F-Alfatide versus 18F-FDG for lymph node metastasis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-Alfatide and 18F-FDG Injection | Experimental | Drug: 18F-Alfatide Injection, Drug: 18F-FDG InjectionThe study is designed as a self-controlled trial, in which participants will be injected and scanned with two drugs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subjects understand the clinical trial procedure and sign the informed consent in person;
- Patients with non-small cell lung cancer confirmed or highly suspected by investigators based on prior history, imaging, histopathology, and/or cytology, suspected lymph node metastasis and proposed radical surgery and lymph node dissection;
- Over 18 years old (including 18 years old);
- ECOG function status score 0~1 points ;
- Expected survival \> 3 months.
Key exclusion criteria (18 listed)
- Known allergic history to 18F-Alfatide Injection and 18F-FDG injection or its excipients;
- Patients who cannot tolerate intravenous drug administration (such as needle fainting and blood fainting history);
- Patients who are not suitable for PET or cannot complete PET or other imaging tests due to special reasons, including claustrophobia and radiophobia;
- Workers who need to be exposed to radioactive conditions for a long time;
- Patients with renal insufficiency were defined as the standard endogenous creatinine clearance (Ccr) estimated by the Cockcroft-Gault formula \<60 ml/min, Ccr(ml/min)=[(140-age)× body weight (kg)]/[72×Scr(mg/dl)], and the calculated result for females was 0.85;
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-Alfatide InjectionA single dose of (0.1~0.15）±0.015 mCi/kg IV injection of 18F-Alfatide. The patients will be intravenously injected with 18F-Alfatide Injection and undergo PET/CT scan at 60 min±10 min after the injection. | Drug | 18F-Alfatide and 18F-FDG Injection |
| 18F-FDG InjectionA single dose of 5～10mCi IV injection of 18F-FDG. The patients will be intravenously injected with 18F-FDG Injection and undergo PET/CT scan at 40 min±10 min after the injection. | Drug | 18F-Alfatide and 18F-FDG Injection |
Primary outcome
Sensitivity and specificity evaluation of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT
Time frame: Through study completion, assessed up to 2 years
To evaluate the sensitivity and specificity of 18F-Alfatide Injection PET/CT in the diagnosis of lymph node metastasis in non-small cell lung cancer compared with 18F-FDG PET/CT.All subjects in this study underwent 18F-Alfatide PET-CT and 18F-FDG PET-CT examination within one week, radical surgery and lymph node dissection within two weeks after the completion of the two scanning images, and pathological examination of the obtained lymph nodes was used as the gold standard.
2 secondary outcomes
Accuracy, positive predictive value and negative predictive value evaluation of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT
Time frame: Through study completion, assessed up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Through study completion, assessed up to 2 years
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 16 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 18F-Alfatide Injection and 18F-FDG Injection in people with Non-Small Cell Lung Cancer NSCLC, run by Yantai LNC Biotechnology Singapore PTE. LTD. 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 18 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 16 May 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity evaluation of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT (time frame: Through study completion, assessed up to 2 years). 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 16 May 2024.