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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02481726
First Posted: June 25, 2015
Last Update Posted: June 25, 2015
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.
Information provided by (Responsible Party):
Xijing Hospital
  Purpose
Comparison of 68Ga-AlfatideII and 18F-FDG in differential diagnosis effectiveness towards the solitary pulmonary nodules of lung cancer or tuberculosis.

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

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • 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:
  • Number of participants with adverse events as a measure of safety after 68Ga-NEB injection and PET/CT scanning. [ Time Frame: 1 year ]

Enrollment: 31
Study Start Date: March 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
No Contacts or Locations Provided
  More Information

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02481726     History of Changes
Other Study ID Numbers: XijingH
First Submitted: June 23, 2015
First Posted: June 25, 2015
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:
Lung Neoplasms
Tuberculosis
Tuberculosis, Pulmonary
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action