Octreoscan - kits production of tumor diagnosis neuroendocrine

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-62qfc8
• Date of registration: 25/04/2015
• Prospective Registration: Yes
• Primary sponsor: UBEA - União Brasileira de Assistência e Saúde
• Public title: Octreoscan - kits production of tumor diagnosis neuroendocrine
• Scientific title: Octreoscan - kits production of tumor diagnosis neuroendocrine
• Date of first enrolment: 01/06/2015
• Recruitment status: Not yet recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-62qfc8
• Study type: Intervention
• Study design: Clinical trial of diagnostic, single group, open, with one arm.
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Cristina Maria Jeckel
• Affiliation: PUCRS

• Name: Cristina Maria Jeckel
• Affiliation: PUCRS

Key inclusion & exclusion 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: Pregnant women;
Patients with previous resection of primary tumor without metastatic disease.

Age minimum: 18Y
Age maximum:
Gender: -

Health Condition(s) or Problem(s) studied

C04.557.465.625.650

Cancer, neuroendocrine tumors (NET)

Intervention(s)

H02.403.429.515

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 patients should be about 30 days without receiving anti-somatostatin treatment. First capturing images with 99mTc, period "Wash out" (2-20 days), Second capturing images with 111In. The evaluation of images will be trained by experts.

H02.403.740.500

Biological/vaccine

Primary Outcome(s)

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 Outcome(s)

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)).

Source(s) of Monetary Support

FINEP - Financiadora de Estudos e Projetos

Secondary Sponsor(s)

Grupo Radiopharmacus - RPH