RecruitingNot ApplicableNCT07026110

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


Sponsor

RenJi Hospital

Enrollment

100 participants

Start Date

Dec 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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.

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.


Locations(1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07026110


Related Trials