68Ga-AlfatideII for the Differential Diagnosis of of Lung Cancer and Lung Tuberculosis by PET/CT

Study Overview
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Brief Summary
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Comparison of 68Ga-AlfatideII and 18F-FDG in differential diagnosis effectiveness towards the solitary pulmonary nodules of lung cancer or tuberculosis.

Conditions
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Lung Cancer, Lung Tuberculosis

Intervention / Treatment
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* Radiation: 68Ga-labeled peptides of dimer RGD (Alfatide II) and 18F-FDG


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga<br>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. | Radiation: 68Ga-labeled peptides of dimer RGD (Alfatide II) and 18F-FDG<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative measurement of standardized uptake values (SUVs) of lesions. | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety after 68Ga-NEB injection and PET/CT scanning. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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68Ga, Alfatide II, RGD, αvβ3, PET/CT