Title International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer
Protocole ID SENTICOL III
ClinicalTrials.gov ID NCT03386734
Cancer Type(s) Cervix
Phase Other
Stage
Study Type Clinical
Drug
Institution CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
City
Principal Investigator Dr. Vanessa Samouëlian
Coordinator France Gauthier
514-890-8000 poste 30921
Status Recruiting
Activation Date
Eligibility Criteria
  • With squamous or adenocarcinoma of the cervix (proven by biopsy or cone biopsy),
  • Stage Ia1 with lymphovascular emboli, Ia2, Ib1 and IIa1 (clinical stage) of the 2009 FIGO classification,
  • Maximum diameter ≤ 40 mm by clinical examination and magnetic resonance imaging (MRI),
  • INo suspicious node on pelvic and abdominal MRI with an exploration up to the femoralleft renal vein (according to RECIST 1.1),
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2,
  • Signed informed consent and ability to comply with follow-up,
Exclusion Criteria
  • Pregnancy,
  • Previous pelvic or abdominal cancer,
  • Previous chemotherapy and/or radiation therapy for the cervical cancer (previous brachytherapy is accepted),
  • Proven allergy to blue dye, isotope or indocyanine green (ICG).