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

NCT07026110 | Recruiting

• 1 other identifier: LY2024-329-C
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer; Lung Diseases; Lung Neoplasms; Lung Cancer Metastatic; Lung Inflammation

Keywords

Trophoblast cell surface antigen 2 (Trop2); Epithelial cell adhesion molecule(EpCAM); ImmunoPET; Lung tumor

Outcome Measures

Primary Outcomes (10)

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

  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.

  1 day from injection of the tracers

• SUV of tumors

  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.

  1 day from injection of the tracers

• Radiation dosimetry of tissues/organs

  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.

  1 day from injection of the tracers

• Radiation dosimetry of tumors

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

  1 day from injection of the tracers

• Radiation dosimetry of whole-body

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

  1 day from injection of the tracers

• Diagnostic sensitivity

  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.

  30 days

• Diagnostic specificity

  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.

  30 days

• Accuracy

  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.

  30 days

• Positive Predictive Value (PPV)

  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.

  30 days

• Negative Predictive Value (NPV)

  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.

  30 days

Secondary Outcomes (5)

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

  3-6 months

• ImmunoPET/CT for postoperative surveillance for patients with lung tumors

  3-6 months

• ImmunoPET/CT for restaging for patients with lung tumors

  3-6 months

• ImmunoPET/CT in evaluating treatment responses

  1-2years

• ImmunoPET/CT in identifying inflammation and tumors in the lungs

  1 day from injection of the tracers

Study Arms (1)

ImmunoPET imaging in patients with lung cancers

EXPERIMENTAL

Enrolled lung cancer patients will undergo a Trop2/EpCAM-targeted immunoPET/CT scanning.

Drug: [68Ga]Ga-NOTA-T4; Drug: [68Ga]Ga-NOTA-RT4; Drug: [18F]F-RESCA-T4; Drug: [18F]F-RESCA-RT4; Drug: [18F]F-RESCA-EPCD6; Drug: [68Ga]Ga-NOTA-EPCD6

Interventions

[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.

Also known as: [68Ga]T4

ImmunoPET imaging in patients with lung cancers

[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.

Also known as: [68Ga]RT4

ImmunoPET imaging in patients with lung cancers

[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.

Also known as: [18F]T4

ImmunoPET imaging in patients with lung cancers

[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.

Also known as: [18F]RT4

ImmunoPET imaging in patients with lung cancers

[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.

Also known as: [18F]F-EPCD6

ImmunoPET imaging in patients with lung cancers

[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.

Also known as: [18F]F-EPCD6

ImmunoPET imaging in patients with lung cancers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, 200127, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Lung Diseases; Pneumonia; Colorectal Cancer, Hereditary Nonpolyposis, Type 8

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Respiratory Tract Infections; Infections

Study Officials

• Weijun Wei

  Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

  STUDY CHAIR

Central Study Contacts

Weijun Wei

CONTACT

15000083153; wwei@shsmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 18, 2025
• Study Start: December 23, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

CN (1)