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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
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.
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.
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.
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.
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.
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.
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China
RECRUITINGBiodistribution-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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days
ImmunoPET/CT in altering initial staging for patients with lung tumors
Assess the role of Trop2 and EpCAM immunoPET/CT in initial staging in terms of the number of metastases.
Time frame: 3-6 months
ImmunoPET/CT for postoperative surveillance for patients with lung tumors
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).
Time frame: 3-6 months
ImmunoPET/CT for restaging for patients with lung tumors
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.
Time frame: 3-6 months
ImmunoPET/CT in evaluating treatment responses
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.
Time frame: 1-2years
ImmunoPET/CT in identifying inflammation and tumors in the lungs
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
Time frame: 1 day from injection of the tracers
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