Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging for Detecting Metastatic Endometrial and Cervical Cancer
Brief Summary: Description:

This is a multi-institutional study investigating the sensitivity and negative predictive value of sentinel lymph nodes mapped with robotic assisted near infrared imaging after cervical injection of indocyanine green (ICG) dye for women with stage I endometrial or cervical cancer at the time of their robotic surgical staging.

Patients will receive cervical injection of 1mg ICG after induction of anesthesia followed by sentinel lymph node mapping using robotic assisted fluorescence imaging. The sentinel lymph nodes identified will be removed and sent for ultraprocessing by pathology. The non-sentinel pelvic and para-aortic (if indicated) non-sentinel nodes will be removed and sent for routine pathologic processing according to standard of care for these surgical procedures. The pathologic results of the sentinel and non-sentinel nodes will be evaluated for sensitivity and negative predictive value in their ability to detect metastatic disease.


Options:
A: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Procedure: No Lymphadenectomy (LNE) | Arm Label: B; Type: EXPERIMENTAL; Interventions: Procedure: Lymphadenectomy (LNE) | Intervention Type: PROCEDURE; Name: No Lymphadenectomy (LNE); Assigned to Arm(s): A | Intervention Type: PROCEDURE; Name: Lymphadenectomy (LNE); Assigned to Arm(s): B
B: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Total Abdominal Radical Hysterectomy | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Procedure: Total Laparoscopic or Robotic Radical Hysterectomy | Intervention Type: PROCEDURE; Name: Total Abdominal Radical Hysterectomy; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: Total Laparoscopic or Robotic Radical Hysterectomy; Assigned to Arm(s): 2
C: Arm Label: IC Green Arm; Type: EXPERIMENTAL; Interventions: Drug: IC Green | Intervention Type: DRUG; Name: IC Green; Assigned to Arm(s): IC Green Arm
D: Arm Label: TH BSO with SNB; Type: EXPERIMENTAL; Interventions: Procedure: TH BSO with SNB Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted | Arm Label: TH BSO without retroperitoneal node dissection; Type: ACTIVE_COMPARATOR; Interventions: Procedure: TH BSO without retroperitoneal node dissection Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted | Intervention Type: PROCEDURE; Name: TH BSO with SNB Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted; Assigned to Arm(s): TH BSO with SNB | Intervention Type: PROCEDURE; Name: TH BSO without retroperitoneal node dissection Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted; Assigned to Arm(s): TH BSO without retroperitoneal node dissection

Answer: C