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

Air Force Military Medical University of People's Liberation Army

Status and phase: Completed; Phase 2; Phase 1

Conditions: Lung Tuberculosis; Lung Cancer

Treatments: Radiation: 68Ga-labeled peptides of dimer RGD (Alfatide II) and 18F-FDG

Study type: Interventional

Funder types: Other

Identifiers

NCT02481726

XijingH (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

31 participants in 1 patient group

68Ga

Experimental group

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.

Treatment:

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