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

Phase 1

Completed

• Conditions: Lung Cancer; Lung Tuberculosis
• Interventions: Radiation: 68Ga-labeled peptides of dimer RGD (Alfatide II) and 18F-FDG

• Registration Number: NCT02481726
• Lead Sponsor: Xijing Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2014-10
• Status Verified: 2015-06
• Study First Submitted: 2015-06-23
• Study First Submitted QC: 2015-06-24
• Last Update Submitted: 2015-06-24
• Study First Posted: 2015-06-25
• Last Update Posted: 2015-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
68Ga	68Ga-labeled peptides of dimer RGD (Alfatide II) and 18F-FDG	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.

Primary Outcome Measures

Name	Time	Method
Quantitative measurement of standardized uptake values (SUVs) of lesions.	1 year	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 Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety after 68Ga-NEB injection and PET/CT scanning.	1 year