Last updated on September 2018

Evaluation of Sentinel Node Policy in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Endometrial Carcinoma
  • Age: Between 18 - 100 Years
  • Gender: Female

Inclusion Criteria:

  1. Patients with early endometrial carcinoma with early FIGO clinical stage I-II (clinical examination, abdomino-pelvic MRI/Ultrasound - or CT scan if MRI not possible
    • and endometrial biopsy or curettage), then stratification of the recurrence risk as defined by European Society for Medical Oncology (ESMO):
    • Intermediate-risk endometrioid (type 1): 2009 FIGO stage IA/T1a grade 3, or IB grade 1 or 2
    • Or High risk endometrioid (type 1) : 2009 FIGO stage IB/T1b grade 3, or II grade 1 or 2 or 3
    • Or High risk non endometrioid (type 2) : 2009 FIGO stages I-II
  2. Without any suspicious pelvic, paraaortic, distant node at preoperative MRI
  3. Age 18 years
  4. Performance status (OMS) 2
  5. No contraindication to surgery
  6. Absence of known hypersensitivity to colloidal rhenium sulphide and technetium (nanocolloid) or one of its excipients, to human albumin preparations, to Nanocoll and Rotop-nanoHSA and their excipients, to injectable dyes (blue dye or indocyanine green if available) or one of their excipients, to triphenylmethane derivatives
  7. Signed and dated informed consent
  8. Effective contraception for patients with reproductive potential
  9. Patient affiliated with a health insurance system

Exclusion Criteria:

  1. Preoperative workup with :
    • Previous hysterectomy (by nature, this trial cannot be offered as a secondary staging procedure)
    • non carcinoma (for example sarcoma, trophoblastic tumor)
    • Low-risk endometrioid carcinoma as defined by the ESMO: 2009 FIGO stage IA grade 1-2
    • Metastatic disease at preoperative workup
    • Suspicious adenopathy at preoperative workup
  2. Pregnant and/or breastfeeding woman
  3. No understanding of the trial
  4. Patient deprived of liberty or in guardianship
  5. Inexperience of the trial site in pelvic sentinel node detection

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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