Clinical trial · Interventional
Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging
Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging for Detecting Metastatic Endometrial and Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IC Green | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IC Green Arm
- description
- One arm only: Receives IC Green for testing of study objective
- interventionNames
- Drug: IC Green
Primary outcomes (1)
- measure
- Estimate the Sensitivity of the Sentinel Lymph Node
- timeFrame
- 3 years
- description
- To estimate the sensitivity of the sentinel lymph node in the determination of lymph node metastases in patients with invasive carcinoma of the cervix and uterus using Indocyanine Green (ICG) and robotic assisted near infrared (NIR) imaging. Sensitivity is defined as the proportion of sentinel lymph node: number of participants with, determined to be metastatic by both IGR/NIR and pathology out of the sentinel lymph nodes found to be metastatic by pathology.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be women 18 years and older who have biopsy proven endometrial or cervical carcinoma (of any histologic subtype). * Surgical staging with the da Vinci Si robotic tool must be planned with a planned pelvic and, in the case of endometrial cancer, a para-aortic lymphadenectomy * Patients must meet criteria for robotic surgical approach: * Patients must have either a clinical stage I endometrial (of any histologic grade) or FIGO stage IA2 or IB1 (\<4cm) cervical squamous, adenocarcinoma or adenosquamous carcinoma. * Patients must be able to sign an informed consent in English language. * Patients with known liver disease will require normal range liver function tests as determined by pre-operative labs drawn within 30 days of surgery. Exclusion Criteria: * Patients who have iodide allergies * Patients who have had previous retroperitoneal surgery * Patients on whom pelvic+/- para-aortic lymphadenectomy is not planned as part of their surgical staging. * Patients who have received previous treatment for their endometrial or cervical cancer (particularly hysterectomy or pelvic radiation). * Patients who are pregnant. * Patients with documented liver disease who have abnormalities of liver function tests.
References
Publications (1)
- DERIVEDRossi EC, Kowalski LD, Scalici J, Cantrell L, Schuler K, Hanna RK, Method M, Ade M, Ivanova A, Boggess JF. A comparison of sentinel lymph node biopsy to lymphadenectomy for endometrial cancer staging (FIRES trial): a multicentre, prospective, cohort study. Lancet Oncol. 2017 Mar;18(3):384-392. doi: 10.1016/S1470-2045(17)30068-2. Epub 2017 Feb 1. PMID 28159465