Clinical trial · Interventional
68Ga-AlfatideII for the Differential Diagnosis of of Lung Cancer and Lung Tuberculosis by PET/CT
NCT02481726CI-TRIAL-00018377completedPhase 1 / Phase 2ClinicalTrials.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)
Comparison of 68Ga-AlfatideII and 18F-FDG in differential diagnosis effectiveness towards the solitary pulmonary nodules of lung cancer or tuberculosis.
Conditions
Conditions (2)
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 Tuberculosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-labeled peptides of dimer RGD (Alfatide II) and 18F-FDG | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga
- description
- In patients in suspicion of lung cancer or lung tuberculosis; in patients with differential diagnosis difficulties; without treatment or surgery. They underwent a standard routine 18F-FDG PET/CT first, and were injected 10\~20MBq 68Ga-Alfatide II in the next day, followed by whole body PET/CT acquisitions.
- interventionNames
- Radiation: 68Ga-labeled peptides of dimer RGD (Alfatide II) and 18F-FDG
Primary outcomes (1)
- measure
- Quantitative measurement of standardized uptake values (SUVs) of lesions.
- timeFrame
- 1 year
- description
- The quantitative analysis will be performed by the same person for all cases, and the standardized uptake value (SUV) of each tumor will be measured using a volume of interest (VOI) method.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Must be able to provide a written informed consent * Males and females, ≥18 years old. * The definite diagnosis of lung cancer was established by pre-operational bronchoscopic or puncture biopsy or the definite diagnosis of lung tuberculomas was established on the basis of positive sputum culture examinations and confirmed by follow-up. * Without any treatment or resection surgury. * All the biopsies are done at least 10 days before PET/CT scans. * Evaluation of cardiac function. Exclusion Criteria: * Females planning to bear a child recently or with childbearing potential； * Known severe allergy or hypersensitivity to IV radiographic contrast； * Inability to lie still for the entire imaging time because of cough, pain, etc. * Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc. * Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.
References
Publications (0)
Data not yet available
No reference posted for this study.