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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ImmunoPET imaging in patients with lung cancers | Experimental | Enrolled lung cancer patients will undergo a Trop2/EpCAM-targeted immunoPET/CT scanning. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-6 months |
| ImmunoPET/CT for postoperative surveillance for patients with lung tumors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weijun Wei | Contact | 15000083153 | wwei@shsmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Weijun Wei | Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Recruiting | Shanghai | 200127 | China |
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| [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. |
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| [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. |
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| [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. |
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| [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. |
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| [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. |
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| 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 |
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). |
| 3-6 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. | 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. | 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 | 1 day from injection of the tracers |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D008171 | Lung Diseases |
| D011014 | Pneumonia |
| C567685 | Colorectal Cancer, Hereditary Nonpolyposis, Type 8 |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012140 | Respiratory Tract Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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