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

NCT02481726 | Completed Phase 1

• 1 other identifier: XijingH
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Lung Cancer; Lung Tuberculosis

Keywords

68Ga; Alfatide II; RGD; αvβ3; PET/CT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with adverse events as a measure of safety after 68Ga-NEB injection and PET/CT scanning.

  1 year

Study Arms (1)

68Ga

EXPERIMENTAL

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

Interventions

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

68Ga

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

MeSH Terms

Conditions

Lung Neoplasms; Tuberculosis, Pulmonary

Interventions

alfatide II; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: June 25, 2015
• Study Start: March 1, 2014
• Primary Completion: October 1, 2014
• Last Updated: June 25, 2015

Record last verified: 2015-06