Malignant neoplasm of trachea, bronchus and lung / Neoplasia Solida
Conditions
Interventions
One group (intra-subject evaluation), 80 patients diagnosed with lung cancer will be recruited and subjected to reviews of new method of image reference method for comparing the staging of the disease
Drug
Radiation
Other
E01.370.350.350.800.800
D01.925
N02.421.143.827.233.110
Sponsors
Esho Empresa de serviços hospitalares S.A. – Hospital Pasteur
CCTECH Tecnologia em Imagem Molecular Ltda
Eligibility
Age
No minimum to 90 Years
Inclusion criteria
Inclusion criteria: Male or female subject with at least 18 years of age. Women may not be pregnant or breast-feeding, and, for those in post-menopausal, the minimum period shall be 12 months for natural process, or 6 months in surgical cases. Agree to adhere to one of the birth control methods (contraceptives) as proposed protocol. Have evidence of lung cancer or CT study results consistent with a diagnosis of lung cancer. Not be receiving cancer treatment (surgery, radiotherapy and / or chemotherapy) or if the person has had lung cancer in the past, all previous therapy should have completed at least 3 months prior to the inclusion in the study. Must have a score in the instrument Eastern Cooperative Oncology Group (ECOG) less than or equal to 2. Present satisfactory laboratory values (l alanine aminotransferase less than or equal to 2.5 x ULN, aspartate aminotransferase less than or equal to 2.5 x ULN; less than or equal to 2.5 x ULN; bilirubin less than or equal to 2.0 x ULN)
Exclusion criteria
Exclusion criteria: If there are any clinically relevant safety concerns (laboratory, ECG, physical examination, other) which, in the opinion of the investigator, put the subject in unnecessary risk if the subject were to participate. If, in the last 3 months, the patient has been submitted to any treatment for Cancer (radiation therapy, surgery or chemotherapy). Diabetic patient with insulin dependency. Weight limit higher than recommended by SPECT / CT and CT table. Known hypersensitivity to ECDG or contrast, or other compound, including any of the inactive ingredients. Pregnancy or suspected pregnancy, lactation, or planned pregnancy (male and female partners). Clinically significant mental illness that compromises the conduct of the study (which should be determined by the investigator).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Considering the limitations of the exam currently standardized in SUS (CT), which does not measure an increase in metabolism of the glycolytic pathway in lung cancer non-small cell, it is expected that the proposed method shows satisfactory sensitivity to detect metabolic alterations associated with lung cancer non-small cell and to present a better performance in both diagnostic parameters as staging when compared to the DCCT. The primary outcome for this study will be the sensitivity of SPECT / CT, calculated from the gold standard (primary malignant lesions). The sensitivity of the tests SPECT / CT is calculated to get the proportion of individuals who test positive in the study population and that have the primary malignant neoplastic lesion (biopsy) using the formula: Sensitivity = True Positive / (True Positive + False Negative) . Exam Result (SPECT / CT): Positive (Standard gold- Malignant Lesion - True Positive); Negative (Standard gold- Malignant Lesion - False Negative). Primary outcome - a sensitivity greater than 90% (95 ± 5%), when compared to the gold standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| The analysis of the secondary outcome is presented by the specificity of SPECT examinations / TC to be calculated to get the proportion of individuals with negative test in the study population and not having the neoplastic lesion (primary and secondary) malignant (clinical and radiological follow-up ) using the formula: specificity = true negative / (true negative + false positive).Test Result (SPECT / CT): positive (standard gold-malignant lesion - true positive) / (injury not maligna- false positive); negative (standard gold-malignant lesion - false negative)) / (injury not true negative maligna-). The sensitivity of the DCCT tests will be calculated to get the proportion of individuals who test positive in the study population who possess the malignant neoplastic lesion using the formula: Sensitivity = True Positive / (True Positive + False Negative). The specificity of the DCCT tests will be calculated to get the proportion of individuals with negative test in the study population and who are not malignant neoplastic lesion using the formula: Specificity = True Negative / (True Negative + False Positive). The positive and negative predictive values, and accuracy ROC curve of SPECT / CT will also be calculated and compared to the values found with the DCCT (CT Diagnosis Contrast). Secondary outcome -a sensitivity and specificity compared with the DCCT and gold reference standard, considered above 90% (= 95% + / - 5%) to 75% (= 80% + / - 5%) respectively validated by standard gold study. | — |
Countries
Brazil
Contacts
Public ContactLuis Diogo Moreira
CCTECH TECNOLOGIA EM IMAGEM MOLECULAR LTDA
Outcome results
None listed