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

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ClinicalTrials.gov Identifier: NCT02481726
Recruitment Status : Completed
First Posted : June 25, 2015
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Study Description
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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

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02481726    
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:
68Ga
Alfatide II
RGD
αvβ3
PET/CT
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Mycobacterium Infections
 Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Respiratory Tract Infections
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action