RBR-3vxgjsj Prospective Evaluation of the Use of PET-CT in Hepatocarcinoma

Date of registration: 07/12/2023 ^(mm/dd/yyyy)
Last approval date : 07/12/2023 ^(mm/dd/yyyy)

Study type:

Observational

Scientific title:

Trial identification

• UTN code: U1111-1294-2164

• Public title:

  en

  Prospective Evaluation of the Use of PET-CT in Hepatocarcinoma

  pt-br

  Avaliação Prospectiva do Uso do PET-CT no Hepatocarcinoma

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 49859721.4.0000.5432
    Issuing authority: Plataforma Brasil
  • 5034269
    Issuing authority: Comitê de Ética em Pesquisa do AC Camargo Cancer Center

Sponsors

• Primary sponsor: Fundação Antônio Prudente - AC Camargo Cancer Center
• Secondary sponsor:
  • Institution: Fundação Antônio Prudente - AC Camargo Cancer Center
• Supporting source:
  • Institution: Fundação Antônio Prudente - AC Camargo Cancer Center

Health conditions

• Health conditions:

  en

  Hepatocellular carcinoma

  pt-br

  Carcinoma hepatocelular

• General descriptors for health conditions:

  en

  C04.588.274.623 Liver Neoplasms

  pt-br

  C04.588.274.623 Neoplasias Hepáticas

• Specific descriptors:

  en

  C04.557.470.200.025.255 Carcinoma Hepatocelular

  pt-br

  C04.557.470.200.025.255 Hepatocellular carcinoma

Interventions

• Interventions:

  en

  Unicentric study, with prospective data collection, which will be developed in the Nuclear Medicine Sector of the Image Department of AC Camargo Cancer Center. A total of 30 patients diagnosed with established HCC will be prospectively included and analyzed with the 18 F-PSMA PET/CT study.

  pt-br

  Estudo observacional, unicêntrico, com coleta prospectiva de dados, que será desenvolvido no Setor de Medicina Nuclear do Departamento de Imagem do A.C.CamargoCancer Center. Um total de 30 pacientes diagnosticados com HCC estabelecido serão prospectivamente incluídos e analisados com o estudo de PET/CT com 18F-PSMA.

• Descriptors:

  en

  E01.370.350.350.800.700.500 Positron Emission Tomography Computed Tomography

  pt-br

  E01.370.350.350.800.700.500 Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 01/01/2023 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  30	-	18 Y	0

• Inclusion criteria:

  en

  A total of 30 patients diagnosed with established hepatocellular carcinoma will be prospectively included and analyzed with the 18F-PSMA (Fluorine-18 Prostate specific Membrane Antigen) PET/CT (Positron emission tomography) study

  pt-br

  Um total de 30 pacientes diagnosticados com Carcinoma Hepatocelular estabelecido serão prospectivamente incluídos e analisados com o estudo de PET/CT (tomografia por emissão de pósitrons) com 18F-PSMA (Flúor-18 antígeno membrana específico da próstata)

• Exclusion criteria:

  en

  none

  pt-br

  não se aplica

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase

Outcomes

• Primary outcomes:

  en

  Evaluate the anomalous concentration of 18F-PSMA in the primary site (liver) as well as in secondary sites (metastases) Using the quantitative method with numerical measurement of the suv (standard uptake value) of the target lesions and jointly the qualitative analysis (visual comparison with normal biodistribution areas).

  pt-br

  Avaliar a concentração anômala do 18F-PSMA no sítio primário (hepático) como também nos sítios secundários (metástases) Utilizando o método quantitativo com a medida numérica do suv (valor de captação padrão) das lesões alvo e conjuntamente a análise qualitativa (visual comparativa com as áreas de biodistribuição normais).

• Secondary outcomes:

  en

  Secondary outcomes are not expected.

  pt-br

  Não são esperados desfechos secundários.

Contacts

• Public contact
  • Full name: Marcelo Cavicchioli
  • • Address: Rua Professor Antônio Prudente, 266
    • City: São Paulo / Brazil
    • Zip code: 01509-001
  • Phone: +55 011 2189-5000 Ramal2832
  • Email: marcelo.cavicchioli@accamargo.org.br
  • Affiliation: AC Camargo Cancer Center
   
• Scientific contact
  • Full name: Eduardo Nóbrega Pereira Lima
  • • Address: R. Prof. Antônio Prudente, 211, Liberdade
    • City: São Paulo / Brazil
    • Zip code: 01509-001
  • Phone: +55 011 2189-5000 Ramal2832
  • Email: eduardo.lima@accamargo.org.br
  • Affiliation: AC Camargo Cancer Center
   
• Site contact
  • Full name: Juliana Oliveira Souza
  • • Address: Rua Professor Antônio Prudente 211
    • City: Sao Paulo / Brazil
    • Zip code: 01509-001
  • Phone: +55 011 2189-5000 Ramal2832
  • Email: juliana.oliveira@accamargo.org.br
  • Affiliation: AC Camargo Cancer Center
   

Additional links:

• Download in ICTRP format