Back to results68Ga-AlfatideII for the Differential Diagnosis of of Lung Cancer and Lung Tuberculosis by PET/CT
Primary Purpose
Lung Cancer, Lung Tuberculosis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
68Ga-labeled peptides of dimer RGD (Alfatide II) and 18F-FDG
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring 68Ga, Alfatide II, RGD, αvβ3, PET/CT
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of participants with adverse events as a measure of safety after 68Ga-NEB injection and PET/CT scanning.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02481726
Brief Title
68Ga-AlfatideII for the Differential Diagnosis of of Lung Cancer and Lung Tuberculosis by PET/CT
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
5. Study Description
Brief Summary
Comparison of 68Ga-AlfatideII and 18F-FDG in differential diagnosis effectiveness towards the solitary pulmonary nodules of lung cancer or tuberculosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lung Tuberculosis
Keywords
68Ga, Alfatide II, RGD, αvβ3, PET/CT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
68Ga
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
68Ga-labeled peptides of dimer RGD (Alfatide II) and 18F-FDG
Primary Outcome Measure Information:
Title
Quantitative measurement of standardized uptake values (SUVs) of lesions.
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of participants with adverse events as a measure of safety after 68Ga-NEB injection and PET/CT scanning.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Learn more about this trial
68Ga-AlfatideII for the Differential Diagnosis of of Lung Cancer and Lung Tuberculosis by PET/CT
We'll reach out to this number within 24 hrs