Lung Cancer, Non-Small CellNCT06648317
Radiolabelled Nectin-4 Targeted LMW Probe PET/CT in Patients With Lung Lesions
An observational study of Lung Cancer, Non-Small Cell and Lung Infection, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
To evaluate the ability of [68Ga]N188 to detect nectin-4 overexpression in patients with lung lesions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Non-Small Cell, Lung Infection
- What is being tested?
- FDG-PET
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2024to 1 Dec 2025
- How long will I take part?
- 2 Years
- 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: patients with lung lesions
Who may be able to join
- 18-75 years old, male or female;
- Heart function is normal;
- Normal heart function;
- Estimated survival ≥12 weeks;
- Good follow-up compliance;
- presence of at least one measurable target lesion according to RECIST1.1 criteria;
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- Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before starting the test; Fertile men and women must agree to use effective contraception to prevent pregnancy during the study period and for 3 months after the test;
- Patients recommended by clinicians to undergo PET/CT examination for tumor diagnostic staging;
- The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent.
Who cannot join
- Serious abnormality of liver, kidney and blood;
- Pregnant patients;
- Pregnant and lactation women;
- 3) unable to lie flat for half an hour; 4) Refuse to join the clinical investigator; 5) Suffering from claustrophobia or other mental diseases; 6) Other conditions that researchers deem unsuitable for participating in the experiment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xin Zhou, MD contact
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100142
Nan Li, MD, +86-010-88197852, rainbow6293@sina.com
Xin Zhou, MD, +86-010-88197852, zhouxinbjmu@163.com
About this study
To evaluate the ability of [68Ga]N188 to detect nectin-4 overexpression in patients with lung lesions.
Read the detailed description
To evaluate the ability of [68Ga]N188 to detect nectin-4 overexpression in patients with different lung lesions, such as inflammation and lung cancer.
- Conditions
- Lung Cancer, Non-Small Cell, Lung Infection
- Being tested
- FDG-PET
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG-PETOther
All study participants will undergo 18F-FDG PET/CT scan within 1 week
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value（SUV）
SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions. The uptake of the tracer （68Ga-N188） in lung lesions by measuring SUV on 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 posted18 Oct 2024
- Study start21 Nov 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Non-Small CellStudies 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)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nanli, Peking University Cancer Hospital & Institute
- Investigators
- Nan Li, MD, Principal investigator, Peking University Cnacer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648317
- Sponsor's protocol ID
- 2022KT37-ZY01-1
- Status last verified
- Nov 2024
- First submitted
- 24 Sep 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiolabelled Nectin-4 Targeted LMW Probe PET/CT in Patients With Lung Lesions
- ClinicalTrials.gov ID
- NCT06648317
- Acronym / sponsor ID
- 2022KT37-ZY01-1
- Conditions
- Lung Cancer, Non-Small Cell, Lung Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 18 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.
To evaluate the ability of [68Ga]N188 to detect nectin-4 overexpression in patients with lung lesions.
Detailed description
To evaluate the ability of [68Ga]N188 to detect nectin-4 overexpression in patients with different lung lesions, such as inflammation and lung cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with lung lesions
Key inclusion criteria (9 listed)
- 18-75 years old, male or female;
- Heart function is normal;
- Normal heart function;
- Estimated survival ≥12 weeks;
- Good follow-up compliance;
Key exclusion criteria (4 listed)
- Serious abnormality of liver, kidney and blood;
- Pregnant patients;
- Pregnant and lactation women;
- 3) unable to lie flat for half an hour; 4) Refuse to join the clinical investigator; 5) Suffering from claustrophobia or other mental diseases; 6) Other conditions that researchers deem unsuitable for participating in the experiment.
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 |
|---|---|---|
| FDG-PETAll study participants will undergo 18F-FDG PET/CT scan within 1 week | Other | – |
Primary outcome
Standardized uptake value（SUV）
Time frame: 1 year
SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions. The uptake of the tracer （68Ga-N188） in lung lesions by measuring SUV on 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 25 Nov 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.
Xin Zhou, MD contact
Nan Li, MD principal investigator
Peking University Cnacer Hospital & Institute
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 Lung Cancer, Non-Small Cell and Lung Infection, 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 9 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 25 Nov 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 Nan Li (+86-13693090647, rainbow6283@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value（SUV） (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 25 Nov 2024.