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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02481726
Recruitment Status : Completed
First Posted : June 25, 2015
Last Update Posted : June 25, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Lung Tuberculosis Radiation: 68Ga-labeled peptides of dimer RGD (Alfatide II) and 18F-FDG Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : March 2014
Actual Primary Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 68Ga
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

Primary Outcome Measures :
  1. Quantitative measurement of standardized uptake values (SUVs) of lesions. [ Time Frame: 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 :
  1. Number of participants with adverse events as a measure of safety after 68Ga-NEB injection and PET/CT scanning. [ Time Frame: 1 year ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Responsible Party: Xijing Hospital Identifier: NCT02481726     History of Changes
Other Study ID Numbers: XijingH
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015

Keywords provided by Xijing Hospital:
Alfatide II

Additional relevant MeSH terms:
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Lung Neoplasms
Tuberculosis, Pulmonary
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action