Cancer, neuroendocrine tumors (NET)
Conditions
Interventions
Single group: 35-39 will be included tests or patients. All patients will both capture images and the minimum time between two images will be 2 days and a maximum of 20 days. To perform image capture
Biological/vaccine
H02.403.740.500
H02.403.429.515
Sponsors
UBEA - União Brasileira de Assistência e Saúde
Grupo Radiopharmacus - RPH
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with histologically proven TNE; Which have been referred for the exam with 111In for staging disease and / or response to treatment; Any stage of the disease; 18 years old; Both sexes; Without receiving medication with somatostatin analogues for at least one month prior to taking pictures.
Exclusion criteria
Exclusion criteria: Pregnant women; Patients with previous resection of primary tumor without metastatic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the presentation of sensitivity, defined as the proportion of participants with metastases in mediastinal lymph nodes (confirmed by histology (gold standard)) which has a positive test (99mTc uptake and / or uptake 111ln) and the presentation of specific, defined as the proportion of participants without metastases in mediastinal lymph nodes (confirmed by histology (gold standard)) which has negative test (99mTc uptake and / or uptake 111ln). The sensitivity of 99mTc (Technetium) is the proportion of patients with radioisotope uptake in the mediastinal lymph nodes among those who truly have metastatic lymph nodes. Moreover, the specificity of 99mTc is the proportion of patients with no radioisotope uptake in mediastinal lymph nodes from among those who truly have metastatic lymph nodes. Will be deemed acceptable, a priori, sensitivity and specificity of at least 90%. | — |
Secondary
| Measure | Time frame |
|---|---|
| As for the secondary outcome, will be presented the positive predictive value is the proportion of participants with positive test (in this case, the 99mTc uptake and / or uptake by 111) that actually have metastases in mediastinal lymph nodes (confirmed by histology (gold standard )) and the negative predictive value is the proportion of participants with negative test (in this case, the 99mTc uptake and / or uptake by 111) that really do not have metastasis in mediastinal lymph nodes (confirmed by histology (gold standard)). | — |
Countries
Brazil
Contacts
Public ContactCristina Jeckel
PUCRS
Outcome results
None listed