Clinical trial · Interventional
Clinical Application Study of PET/CT for Differential Diagnosis of Non-small Cell Lung Cancer
NCT07026110CI-TRIAL-00091133recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer Metastatic | — | UNRESOLVED | — |
| Lung Diseases | — | UNRESOLVED | — |
| Lung Inflammation | — | UNRESOLVED | — |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]F-RESCA-EPCD6 | Drug | — | UNRESOLVED |
| [18F]F-RESCA-RT4 | Drug | — | UNRESOLVED |
| [18F]F-RESCA-T4 | Drug | — | UNRESOLVED |
| [68Ga]Ga-NOTA-EPCD6 | Drug | — | UNRESOLVED |
| [68Ga]Ga-NOTA-RT4 | Drug | — | UNRESOLVED |
| [68Ga]Ga-NOTA-T4 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ImmunoPET imaging in patients with lung cancers
- description
- Enrolled lung cancer patients will undergo a Trop2/EpCAM-targeted immunoPET/CT scanning.
- interventionNames
- 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
Primary outcomes (10)
- measure
- Biodistribution-Standardized uptake value (SUV) of normal tissues and organs.
- timeFrame
- 1 day from injection of the tracers
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-80 years; 2. Imaging studies suspecting non-small cell lung cancer; 3. 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; 4. Patients or family members agreed to participate in this clinical study and signed an informed consent form. Exclusion Criteria: 1. Women during pregnancy and lactation; 2. Persons with a history of surgery and trauma that significantly affects metabolic distribution and anatomical structure; 3. Persons with severe other systemic diseases or known hypersensitivity to humanized monoclonal antibody products; 4. Patient is unable to cooperate in completing the PET/CT examination; 5. 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; 6. Patient should not participate in this clinical trial in the opinion of the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.