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

Lung Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481726
• Other study ID #: XijingH
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 23, 2015
• Last updated: June 24, 2015
• Start date: March 2014

Study information

• Verified date: June 2015
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee of Fourth Military Medical University
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer
• Lung Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of participants with adverse events as a measure of safety after 68Ga-NEB injection and PET/CT scanning.		1 year	No