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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02481726
Enrollment
31
Registered
2015-06-25
Start date
2014-03-31
Completion date
Unknown
Last updated
2015-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Lung Tuberculosis

Keywords

68Ga, Alfatide II, RGD, αvβ3, PET/CT

Brief summary

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

Interventions

RADIATION68Ga-labeled peptides of dimer RGD (Alfatide II) and 18F-FDG

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Quantitative measurement of standardized uptake values (SUVs) of lesions.1 yearThe 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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026