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Completed

NCT Number: NCT02481726

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

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

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Radiation

Primary outcomes

  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 outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
First posted
Jun 25, 2015
Registry last updated
Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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