Recruiting NCT07026110

Clinical Application Study of PET/CT for Differential Diagnosis of Non-small Cell Lung Cancer

No phase Interventional Lung Cancer Lung Diseases Lung Neoplasms Lung Cancer Metastatic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: [68Ga]Ga-NOTA-T4, [68Ga]Ga-NOTA-RT4, [18F]F-RESCA-T4, [18F]F-RESCA-RT4.
Who it may be relevant to: Registry conditions: Lung Cancer, Lung Diseases, Lung Neoplasms, Lung Cancer Metastatic. Basic parameters: 18 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

This study aims to explore the efficacy of Trop2, EpCAM-specific PET/CT imaging for noninvasive visualization of Trop2 or EpCAM expression levels in non-small cell lung cancer; and to explore the differences between novel target-specific PET/CT examinations and conventional 18F-FDG PET/CT in the diagnosis and differential diagnosis of solid lung nodules.

Detailed description

A solid lung nodule was initially diagnosed as non-small cell lung cancer by chest CT. Patients with lung nodules subjected to 18F-FDG PET/CT with surgical resection/biopsy. Patients will also be included for routine follow-up, surveillance, and treatment efficacy evaluation.Enrolled patients will undergo whole-body immunoPET/CT scans 1-2 hours after tracer injection (0.05-0.1 mCi/kg). The uptake of imaging tracers in tumors and normal organs/tissues will be scored visually and quantitatively.Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to assess the diagnostic efficacy. The correlation between lesion uptake and Trop2 and EpCAM expression level determined by immunohistochemistry staining will be further analyzed. The primary exploration endpoint will be the tracers' imaging feasibility and preliminary diagnostic value compared to conventional imaging approaches like 18F-FDG PET/CT.

Interventions

Drug [68Ga]Ga-NOTA-T4
Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-T4 injection.
Drug [68Ga]Ga-NOTA-RT4
Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-RT4 injection.
Drug [18F]F-RESCA-T4
Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-T4 injection.
Drug [18F]F-RESCA-RT4
Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-RT4 injection.
Drug [18F]F-RESCA-EPCD6
Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-EPCD6. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-EPCD6 injection.
Drug [68Ga]Ga-NOTA-EPCD6
Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-EPCD6. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-EPCD6 injection.

Primary outcome measures

Biodistribution-Standardized uptake value (SUV) of normal tissues and organs. [Time frame: 1 day from injection of the tracers]
SUV of tumors [Time frame: 1 day from injection of the tracers]
Radiation dosimetry of tissues/organs [Time frame: 1 day from injection of the tracers]
Radiation dosimetry of tumors [Time frame: 1 day from injection of the tracers]
Radiation dosimetry of whole-body [Time frame: 1 day from injection of the tracers]
Diagnostic sensitivity [Time frame: 30 days]
Diagnostic specificity [Time frame: 30 days]
Accuracy [Time frame: 30 days]
Positive Predictive Value (PPV) [Time frame: 30 days]
Negative Predictive Value (NPV) [Time frame: 30 days]

Secondary outcome measures (5)

ImmunoPET/CT in altering initial staging for patients with lung tumors [Time frame: 3-6 months]
ImmunoPET/CT for postoperative surveillance for patients with lung tumors [Time frame: 3-6 months]
ImmunoPET/CT for restaging for patients with lung tumors [Time frame: 3-6 months]
ImmunoPET/CT in evaluating treatment responses [Time frame: 1-2years]
ImmunoPET/CT in identifying inflammation and tumors in the lungs [Time frame: 1 day from injection of the tracers]

Eligibility criteria

Inclusion criteria

Age 18-80 years;
Imaging studies suspecting non-small cell lung cancer;
Solid lung nodules (≥8 mm in diameter) diagnosed by chest ct, which are subject to 18F-FDG PET/CT and surgical resection/biopsy of lung nodules according to the NCCN guideline specifications for NSCLC in the 2024 edition;
Patients or family members agreed to participate in this clinical study and signed an informed consent form.

Exclusion criteria

Women during pregnancy and lactation;
Persons with a history of surgery and trauma that significantly affects metabolic distribution and anatomical structure;
Persons with severe other systemic diseases or known hypersensitivity to humanized monoclonal antibody products;
Patient is unable to cooperate in completing the PET/CT examination;
Patient has participated in other clinical studies within the past year that have resulted in radiation exposures in excess of an effective dose of 50 mSv, in addition to the radiation exposures anticipated from participation in this clinical study;
Patient should not participate in this clinical trial in the opinion of the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Diagnostic

Study locations

China · 1 center

Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai

Identifiers

NCT: NCT07026110 · LY2024-329-C

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗