A Single-arm, Open-label, Single-center Clinical Study to Evaluate CDH3-targeted Positron Emission Tomography (PET) for Lung Malignant Tumors
New PET Scan for Lung Cancer Diagnosis
Plain English Summary
Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors is a Not Applicable clinical trial sponsored by Peking University People's Hospital studying Non-Small Cell Lung Cancer, Malignant Neoplasm, Pulmonary Nodules, PET/CT. This study tests a new type of PET scan that uses a special tracer to find lung tumors. It is for adults with suspected or confirmed lung cancer who are candidates for surgery or biopsy. Participants will receive the new PET scan and have their medical information reviewed. Current alternatives include standard PET scans (like 18F-FDG PET) and biopsies. The trial aims to enroll 80 participants.
Official Summary
Lung malignant tumors are a significant health threat with high incidence and mortality rates, and molecular imaging is crucial for early diagnosis, staging, prognosis evaluation, and therapeutic efficacy assessment. 18F-FDG PET imaging is widely used, but has limitations. CDH3 is a promising target for tumor-targeted imaging, as it is only expressed in cancerous epithelial cells. A new PET probe, 68Ga-TOI-1, targeting CDH3 has been developed with better affinity and selectivity than previous probes. Preclinical data support its safety and metabolic stability, and future research will explore its diagnostic and staging value in different types of lung tumors, providing a new and precise evaluation method for lung malignant tumors.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with good general health and a performance status of 0 or 1. Patients with confirmed lung cancer eligible for surgery or biopsy, or those strongly suspected of having malignant lung nodules. Individuals must have adequate blood counts, liver, and kidney function. People who are pregnant, planning to become pregnant, or breastfeeding cannot participate. This trial is studying Non-Small Cell Lung Cancer, Malignant Neoplasm, Pulmonary Nodules, PET/CT, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how well the new PET scan can accurately identify and stage lung tumors, meaning it will show how good it is at finding cancer and determining its extent. The specific primary outcome measures are: The diagnostic sensitivity and specificity of 68Ga-TOI-1 PET/CT in the staging of lung malignant tumors. (up to 6 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to provide a more precise way to diagnose and stage lung cancer, potentially improving early detection and treatment planning. This research targets Non-Small Cell Lung Cancer, Malignant Neoplasm, Pulmonary Nodules, PET/CT, where improved treatment options are needed.
Investor Insight
This trial explores a novel diagnostic tool for a major cancer type, indicating potential for improved imaging accuracy and a new market for specialized PET tracers.
Is This Trial Right for Me?
Ask your doctor if this new PET scan is appropriate for your specific situation and how it compares to standard imaging. Participation involves undergoing the PET scan and providing medical history and imaging data. The day-to-day involvement is minimal, primarily consisting of the scan appointment and follow-up discussions with your doctor. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 80 participants
Interventions
- DIAGNOSTIC_TEST: PET/CT scans — PET Dynamic Data: The tracer is administered based on the patient's body weight at approximately 0.06-0.12 mCi/kg. PET scanning is initiated simultaneously with tracer injection, followed by a flush with 10 ml of normal saline. The image acquisition matrix is 192 × 192. Reconstruction is performed using the OSEM algorithm with 4 iterations and 20 subsets, incorporating time-of-flight attenuation correction, scatter correction, and random correction. The total duration of PET dynamic data acquisi
Primary Outcomes
- The diagnostic sensitivity and specificity of 68Ga-TOI-1 PET/CT in the staging of lung malignant tumors. (up to 6 weeks)
Secondary Outcomes
- Maximum Standardized Uptake Value [SUVmax] of Primary and Metastatic Lesions on 68Ga-TOI-1 PET/CT vs. 18F-FDG PET/CT (up to 6 weeks)
- Mean Standardized Uptake Value [SUVmean] of Primary and Metastatic Lesions on 68Ga-TOI-1 PET/CT vs. 18F-FDG PET/CT (up to 6 weeks)
- Correlation between 68Ga-TOI-1 SUVmax and CDH3 H-score in Tumor Tissue (up to 6 weeks)
- Correlation between 68Ga-TOI-1 SUVmean and CDH3 H-score in Tumor Tissue (up to 6 weeks)
Full Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years, male or female, with an ECOG performance status of 0 or 1; 2. Availability of complete clinical and imaging data; 3. Life expectancy ≥ 12 weeks; 4. Hematology, liver and kidney function meeting the following criteria: Hematology: WBC ≥ 4.0 × 10⁹/L or neutrophils ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, Hb ≥ 90 g/L; PT or APTT ≤ 1.5 × ULN; Liver and kidney function: T-Bil ≤ 1.5 × ULN, ALT/AST ≤ 2.5 × ULN, ALP ≤ 2.5 × ULN; BUN ≤ 1.5 × ULN, SCr ≤ 1.5 × ULN; 5. Patients who have not received radiotherapy or chemotherapy and are eligible for surgical resection or biopsy to obtain a pathological diagnosis, or those highly suspected of having malignant pulmonary nodules according to clinical diagnostic criteria; 6. Pathologically confirmed lung cancer via biopsy before neoadjuvant therapy; life expectancy ≥ 12 weeks; 7. Ability to provide adequate tumor tissue for testing and research. Exclusion Criteria: 1. Women who are planning pregnancy, pregnant, or breastfeeding; 2. History of other malignant tumors or prior receipt of other anti-tumor therapies; 3. Poor or missing PET scan image quality of the probe that fails to meet analysis standards; 4. Presence of claustrophobia or other mental illnesses; 5. Any other conditions deemed by the investigators as inappropriate for participation in this study.
Trial Locations
- Peking University People's Hospital, Beijing, Beijing Municipality, China
Frequently Asked Questions
What is clinical trial NCT07487883?
NCT07487883 is a Not Applicable OBSERVATIONAL study titled "Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors." It is currently recruiting and is sponsored by Peking University People's Hospital. The trial targets enrollment of 80 participants.
What conditions does NCT07487883 study?
This trial investigates treatments for Non-Small Cell Lung Cancer, Malignant Neoplasm, Pulmonary Nodules, PET/CT. The primary condition under study is Non-Small Cell Lung Cancer.
What treatments are being tested in NCT07487883?
The interventions being studied include: PET/CT scans (DIAGNOSTIC_TEST). PET Dynamic Data: The tracer is administered based on the patient's body weight at approximately 0.06-0.12 mCi/kg. PET scanning is initiated simultaneously with tracer injection, followed by a flush with 10 ml of normal saline. The image acquisition matrix is 192 × 192. Reconstruction is performed using the OSEM algorithm with 4 iterations and 20 subsets, incorporating time-of-flight attenuation correction, scatter correction, and random correction. The total duration of PET dynamic data acquisi
What does Not Applicable mean for NCT07487883?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07487883?
This trial is currently "Recruiting." It started on 2026-03-18. The estimated completion date is 2027-07-30.
Who is sponsoring NCT07487883?
NCT07487883 is sponsored by Peking University People's Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07487883?
The trial aims to enroll 80 participants. The trial is currently recruiting and accepting new participants.
How is NCT07487883 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07487883?
The primary outcome measures are: The diagnostic sensitivity and specificity of 68Ga-TOI-1 PET/CT in the staging of lung malignant tumors. (up to 6 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07487883 being conducted?
This trial is being conducted at 1 site, including Beijing, Beijing Municipality (China).
Where can I find official information about NCT07487883?
The official record for NCT07487883 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07487883. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07487883 testing in simple terms?
This study tests a new type of PET scan that uses a special tracer to find lung tumors. It is for adults with suspected or confirmed lung cancer who are candidates for surgery or biopsy.
Why is this trial significant?
This trial matters because it aims to provide a more precise way to diagnose and stage lung cancer, potentially improving early detection and treatment planning.
What are the potential risks of participating in NCT07487883?
The main risks are related to the PET scan procedure itself, which is generally considered safe. Potential side effects are typically mild and may include reactions at the injection site or temporary discomfort. The tracer used is being tested, so unknown risks, though unlikely, are a possibility. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07487883?
Ask your doctor if this new PET scan is appropriate for your specific situation and how it compares to standard imaging. Participation involves undergoing the PET scan and providing medical history and imaging data. The day-to-day involvement is minimal, primarily consisting of the scan appointment and follow-up discussions with your doctor. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07487883 signal from an investment perspective?
This trial explores a novel diagnostic tool for a major cancer type, indicating potential for improved imaging accuracy and a new market for specialized PET tracers. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive the new PET scan and have their medical information reviewed. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.