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NCT Number: NCT07026110

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

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.

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Key information

Conditions

Lung Cancer Colorectal Cancer, Hereditary Nonpolyposis, Type 8 Infections Lung Cancer Metastatic Lung Diseases Lung Inflammation Lung Neoplasms Neoplasms Neoplasms by Site Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[68Ga]Ga-NOTA-T4

Drug

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.

Other names: [68Ga]T4

[68Ga]Ga-NOTA-RT4

Drug

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.

Other names: [68Ga]RT4

[18F]F-RESCA-T4

Drug

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.

Other names: [18F]T4

[18F]F-RESCA-RT4

Drug

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.

Other names: [18F]RT4

[18F]F-RESCA-EPCD6

Drug

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.

Other names: [18F]F-EPCD6

[68Ga]Ga-NOTA-EPCD6

Drug

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.

Other names: [18F]F-EPCD6

Primary outcomes

  1. Biodistribution-Standardized uptake value (SUV) of normal tissues and organs.

    Time frame: 1 day from injection of the tracers

    Measurement of the overall biodistribution of the above tracers in normal tissues and organs (bladder (after voiding), background (pelvic fat), blood, brain, salivary and lacrimal glands, lung, liver, spleen, pancreas, small intestine, and kidneys). To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.

  2. SUV of tumors

    Time frame: 1 day from injection of the tracers

    The SUV of the above tracers in the primary and/or metastatic lesions of the included subjects. To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.

  3. Radiation dosimetry of tissues/organs

    Time frame: 1 day from injection of the tracers

    Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs. The following tissues were included: adrenals, brain, breasts, gallbladder, small intestine, upper and lower large intestine, stomach, heart contents, heart muscle, kidney, liver, lung, muscle, ovaries, pancreas, red marrow, trabecular and cortical bone, spleen, testes, thymus, thyroid, urinary bladder, and uterus. Dynamic imaging within one hour will be performed for this purpose.

  4. Radiation dosimetry of tumors

    Time frame: 1 day from injection of the tracers

    Measurement of absorbed radiation doses (Gy/MBq) to tumors. Dynamic imaging within one hour will be performed for this purpose.

  5. Radiation dosimetry of whole-body

    Time frame: 1 day from injection of the tracers

    Whole-body activity was measured using a large volume of interest (VOI) covering the entire subject.

  6. Diagnostic sensitivity

    Time frame: 30 days

    Sensitivity = (True Positives) / (True Positives + False Negatives). The diagnostic value of Trop2 and EpCAM immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.

  7. Diagnostic specificity

    Time frame: 30 days

    Specificity = (True Negatives) / (True Negatives + False Positives). The diagnostic value of Trop2 and EpCAM immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.

  8. Accuracy

    Time frame: 30 days

    Accuracy = (True Positives + True Negatives) / (Total Tests). The diagnostic value of Trop2 and EpCAM immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.

  9. Positive Predictive Value (PPV)

    Time frame: 30 days

    PPV = (True Positives) / (True Positives + False Positives). The diagnostic value of Trop2 and EpCAM immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.

  10. Negative Predictive Value (NPV)

    Time frame: 30 days

    NPV = (True Negatives) / (True Negatives + False Negatives). The diagnostic value of Trop2 and EpCAM immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.

Secondary outcomes

  1. ImmunoPET/CT in altering initial staging for patients with lung tumors

    Time frame: 3-6 months

    Assess the role of Trop2 and EpCAM immunoPET/CT in initial staging in terms of the number of metastases.

  2. ImmunoPET/CT for postoperative surveillance for patients with lung tumors

    Time frame: 3-6 months

    Assess the role of Trop2 and EpCAMimmunoPET/CT in surveillance in terms of the number of metastases, Trop2 and EpCAM-derived tumor volume (Trop2 and EpCAM-TV), and total lesion Trop2 uptake (Trop2 and EpCAM-TLU).

  3. ImmunoPET/CT for restaging for patients with lung tumors

    Time frame: 3-6 months

    Assess the role of Trop2 and EpCAM immunoPET/CT in restaging in terms of the number of metastases, Trop2 and EpCAM-TV, and Trop2 and EpCAM-TLU.

  4. ImmunoPET/CT in evaluating treatment responses

    Time frame: 1-2years

    We will also investigate the role of Trop2 and immunoPET/CT in predicting and evaluating the treatment efficacy in patients with lung tumors. The treatment regimens involve chemotherapy, molecularly targeted therapies, immunotherapies (e.g. PD-1/PD-L1 inhibitors), and cell therapies.

  5. ImmunoPET/CT in identifying inflammation and tumors in the lungs

    Time frame: 1 day from injection of the tracers

    We will also investigate the role of Trop2 and immunoPET/CT in identifying the benign and malignant nature of pulmonary lesions and hilar and mediastinal lymph nodes

Study contacts

Contact information is provided by the study sponsor or research team.

Weijun Wei

CONTACT

[email protected]

15000083153

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2025
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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