RBR-6d36dgq Evaluation of the modern indocyanine green dye in the breast cancer scenario

Date of registration: 08/17/2022 ^(mm/dd/yyyy)
Last approval date : 08/17/2022 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1279-4407

• Public title:

  en

  Evaluation of the modern indocyanine green dye in the breast cancer scenario

  pt-br

  Avaliação do moderno corante verde indocianina no cenário do câncer de mama

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 08169419.9.0000.5505
    Issuing authority: Plataforma Brasil
  • 3.234.584
    Issuing authority: Comitê de Ética em Pesquisa da Universidade Federal de São Paulo

Sponsors

• Primary sponsor: Universidade Federal de São Paulo
• Secondary sponsor:
  • Institution: Hospital Regional do Câncer de Presidente Prudente
• Supporting source:
  • Institution: Universidade Federal de São Paulo

Health conditions

• Health conditions:

  en

  Breast cancer; Sentinel lymph node

  pt-br

  Câncer de Mama; Linfonodo sentinela

• General descriptors for health conditions:

  en

  E01.789.625 Neoplasm Staging

  pt-br

  E01.789.625 Estadiamento de Neoplasias

• Specific descriptors:

  en

  C04.588.180 Breast cancer

  pt-br

  C04.588.180 Câncer de mama

  en

  A10.549.400.750 Sentinel lymph node

  pt-br

  A10.549.400.750 Linfonodo sentinela

Interventions

• Interventions:

  en

  986 / 5.000 Resultados de tradução star_border Patients with previously clinically negative axillary breast cancer underwent sentinel lymph node biopsy using one of 3 sentinel lymph node techniques determined according to the dye used. 33 patients underwent indocyanine green dye, 33 patients underwent patent blue dye, and 33 patients underwent combined use of indocyanine green and patent blue. The allocation was sequential according to the patient's inclusion in the research: the first 33 were submitted to patent blue; patient 34 to 66 underwent indocyanine green and finally patients 67 to 99 were submitted to the combined method (patent blue + indocyanine green). There was no masking. The sentinel lymph node identification rate (stained or not) was evaluated, as well as the time to detection and the total surgical time. The main objective of the study was to compare the sentinel lymph node detection rate among the 3 techniques performed

  pt-br

  As pacientes portadoras de câncer de mama com axila clinicamente negativa previamente foram submetidas a biópsia do linfonodo sentinela utilizando uma das 3 técnicas do linfonodo sentinela determinada conforme o corante utilizado. 33 pacientes foram submetidas ao corante verde indocianina, 33 pacientes foram submetidas ao corante azul patente e 33 pacientes foram submetidas ao uso combinado de verde indocianina e azul patente. A alocação das pacientes foi sequencial pela inserção da paciente na pesquisa: as 33 primeiras submetidas ao azul patente; a paciente 34 até a 66 submetida ao verde indocianina e por fim as pacientes 67 até a 99 foram submetidas ao método combinado (azul patente + verde indocianina). Não houve mascaramento. Foi avaliado a taxa de identificação do linfonodo sentinela (corado ou não), além do tempo para a detecção e o tempo cirúrgico total. O objetivo principal do estudo foi a comparação da taxa de detecção do linfonodo sentinela entre as 3 técnicas realizadas

• Descriptors:

  en

  E04.074.580 sentinel lymph node biopsy

  pt-br

  E04.074.580 biópsia do linfonodo sentinela

  en

  D03.633.100.473.400 Indocyanine green

  pt-br

  D03.633.100.473.400 Verde indocianina

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 08/02/2019 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  99	F	0	0

• Inclusion criteria:

  en

  Clinically negative axillary breast cancer; present surgical indication

  pt-br

  Câncer de mama com axila clinicamente negativa; apresentar indicação cirúrgica

• Exclusion criteria:

  en

  T4 (chest wall or skin involvement or inflammatory); N1 (single lymph node affected); N2 (conglomerate of affected lymph nodes; N3 (supra or infraclavicular lymph node involvement; Having undergone neoadjuvant chemotherapy

  pt-br

  T4 (acometimento de parede torácica ou pele ou inflamatório); N1 (linfonodo único acometido); N2 (conglomerado de linfonodos acometidos); N3 (acometimento de linfonodo supra ou infraclavicular); Ter sido submetida à quimioterapia neoadjuvante

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Diagnostic	Other	3	Open	Non-randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Expected outcome 1 It is expected to find a high rate of sentinel lymph node identification through fluorescence

  pt-br

  Desfecho esperado 1 Espera-se encontrar alta taxa de identificação do linfonodo sentinela através da fluorescência

  en

  Endpoint found 1 A higher rate of sentinel lymph node detection was observed in patients undergoing the sentinel lymph node technique with the combined use of dyes (100%) compared to isolated dyes (patent blue: 78.8%, indocyanine green: 93.9%)

  pt-br

  Desfecho encontrado 1 Foi verificado maior taxa de detecção do linfonodo sentinela nas pacientes submetidas à técnica do linfonodo sentinela com o uso combinado dos corantes (100%) em comparação com os corantes isolados (azul patente: 78,8%, verde indocianina: 93,9%)

• Secondary outcomes:

  en

  Secondary outcomes are not expected.

  pt-br

  Não são esperados desfechos secundários.

Contacts

• Public contact
  • Full name: Rafael da Silva Sa
  • • Address: Rua Osvaldo Klebis, 79
    • City: Presidente Prudente / Brazil
    • Zip code: 19053-791
  • Phone: 55(18)981514255
  • Email: rafasamed@hotmail.com
  • Affiliation: Hospital Regional do Câncer de Presidente Prudente
   
• Scientific contact
  • Full name: Rafael da Silva Sa
  • • Address: Rua Osvaldo Klebis, 79
    • City: Presidente Prudente / Brazil
    • Zip code: 19053-791
  • Phone: 55(18)981514255
  • Email: rafasamed@hotmail.com
  • Affiliation: Hospital Regional do Câncer de Presidente Prudente
   
• Site contact
  • Full name: Rafael da Silva Sa
  • • Address: Rua Osvaldo Klebis, 79
    • City: Presidente Prudente / Brazil
    • Zip code: 19053-791
  • Phone: 55(18)981514255
  • Email: rafasamed@hotmail.com
  • Affiliation: Hospital Regional do Câncer de Presidente Prudente
   

Additional links:

• Download in ICTRP format