Phase
Condition
Dysfunctional Uterine Bleeding
Endometrial Cancer
Carcinoma
Treatment
Current initial staging protocols
Pre-operative SN mapping with radionucleide
Full bilateral laparoscopic lymphadenectomy and Hysterectomy
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with early endometrial carcinoma with early FIGO clinical stage I-II (clinical examination, abdomino-pelvic MRI/Ultrasound - or CT scan if MRI notpossible - and endometrial biopsy or curettage), then stratification of therecurrence risk as defined by last European Society for Medical Oncology (ESMO)guidelines :
Intermediate-risk endometrioid (type 1): FIGO stage IA/T1a grade 3, or IB grade 1 or 2
Or High risk endometrioid (type 1) : FIGO stage IB/T1b grade 3, or II grade 1or 2 or 3
Or High risk non endometrioid (type 2) : FIGO stages I-II
Without any suspicious pelvic, paraaortic, distant node at preoperative MRI
Age ≥ 18 years
Performance status (OMS) ≤ 2
No contraindication to surgery
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 indocyaninegreen if available) or one of their excipients, to triphenylmethane derivatives
Signed and dated informed consent
Effective contraception for patients with reproductive potential
Patient affiliated with a health insurance system
Exclusion
Exclusion Criteria:
- Preoperative workup with :
Previous hysterectomy (by nature, this trial cannot be offered as a secondarystaging procedure)
non carcinoma (for example sarcoma, trophoblastic tumor)
Low-risk endometrioid carcinoma as defined by the ESMO: 2009 FIGO stage IAgrade 1-2
Metastatic disease at preoperative workup
Suspicious adenopathy at preoperative workup
Pregnant and/or breastfeeding woman
No understanding of the trial
Patient deprived of liberty or in guardianship
Inexperience of the trial site in pelvic sentinel node detection
Study Design
Study Description
Connect with a study center
Polyclinique Urbain V
Avignon, 84036
FranceSite Not Available
Polyclinique Urbain V
Avignon 3035681, 84036
FranceSite Not Available
Centre Hospitalier Régional Universitaire
Besançon, 25000
FranceSite Not Available
Centre Hospitalier Régional Universitaire
Besançon 3033123, 25000
FranceSite Not Available
Institut Bergonié
Bordeaux, 33076
FranceSite Not Available
Institut Bergonié
Bordeaux 3031582, 33076
FranceSite Not Available
CHU Clermont-Ferrand
Clermont-Ferrand,
FranceSite Not Available
Centre Jean Perrin
Clermont-Ferrand, 63011
FranceSite Not Available
Centre Jean Perrin
Clermont-Ferrand 3024635, 63011
FranceSite Not Available
Centre Georges François Leclerc
Dijon,
FranceSite Not Available
Centre Georges François Leclerc
Dijon 3021372,
FranceSite Not Available
Centre Oscar Lambret
Lille, 59020
FranceSite Not Available
Hôpital Jeanne de Flandres, CHRU Lille
Lille, 59037
FranceSite Not Available
Centre Oscar Lambret
Lille 2998324, 59020
FranceSite Not Available
Hôpital Jeanne de Flandres, CHRU Lille
Lille 2998324, 59037
FranceSite Not Available
Hôpital Mère-Enfant, CHU Limoges
Limoges, 87042
FranceSite Not Available
Hôpital Mère-Enfant, CHU Limoges
Limoges 2998286, 87042
FranceSite Not Available
Centre Léon Bérard
Lyon, 69008
FranceSite Not Available
Centre Léon Bérard
Lyon 2996944, 69008
FranceSite Not Available
Institut Paoli Calmettes
Marseille, 13273
FranceSite Not Available
Institut Paoli Calmettes
Marseille 2995469, 13273
FranceSite Not Available
ICM Val d'Aurelle
Montpellier, 34298
FranceSite Not Available
ICM Val d'Aurelle
Montpellier 2992166, 34298
FranceSite Not Available
Institut de Cancérologie de l'Ouest, René Gauducheau
Nantes Saint-Herblain, 44805
FranceSite Not Available
Hôpital Européen Georges Pompidou
Paris, 75015
FranceSite Not Available
Hôpital La Pitié-Salpêtrière
Paris, 75013
FranceSite Not Available
Hôpital Européen Georges Pompidou
Paris 2988507, 75015
FranceSite Not Available
Hôpital La Pitié-Salpêtrière
Paris 2988507, 75013
FranceSite Not Available
Institut Jean Godinot
Reims, 51056
FranceSite Not Available
Institut de Cancérologie de l'Ouest, René Gauducheau
Saint-Herblain, 44805
FranceSite Not Available
Institut de Cancérologie de l'Ouest, René Gauducheau
Saint-Herblain 2979590, 44805
FranceSite Not Available
Centre Hospitalier Universitaire
Strasbourg, 67098
FranceSite Not Available
Centre Paul Strauss
Strasbourg, 67065
FranceSite Not Available
Centre Paul Strauss
Strasbourg 2973783, 67065
FranceSite Not Available
Institut Claudius Regaud
Toulouse, 31059
FranceSite Not Available
Institut Claudius Regaud
Toulouse 2972315, 31059
FranceSite Not Available
Institut Gustave Roussy
Villejuif, 94800
FranceSite Not Available

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