Cervical Cancer, Endometrial Cancer
Conditions
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.
Detailed description
Brief Summary: Patients with early stage endometrial and cervical cancer who are undergoing robotic surgery to remove the uterus, cervix and lymph nodes will have dye injected into the cervix after they are asleep from anesthesia prior to performing the surgery. During the surgery, the surgeon will activate the robotic camera that is being used to visualize the internal organs changing it to a special mode of imaging called near infrared imaging. The near infrared imaging will allow the surgeon to see where the dye that was injected into the cervix has spread. The dye travels through vessels called lymphatic channels to nodules called sentinel lymph nodes. These are the tissues the surgeon is most interested in removing in order to see if there has been spread of their cancer to those nodules. The dye that travels to the lymph nodes makes them more easily visible to the surgeon. Without the dye, these nodes are indistinguishable from the surrounding fatty tissue. The nodes that have dye in them will be removed from the patient and sent to the pathologist, where they will be very closely examined, called ultrasectioning, for cancer spread. The surgeon will remove the remaining lymphatic tissue (all of the fatty and lymphatic tissue that surrounded the sentinel lymph node that did not stain with the dye), as these are the non-sentinel lymph nodes, and are the tissue that is traditionally removed with endometrial and cervical cancer surgery as part of standard of care. These non-sentinel lymph nodes will also be examined for evidence of cancer spread. The researchers will compare the pathology results from the sentinel nodes and non-sentinel nodes. The researchers hypothesize that the sentinel nodes contain cancer cells at least 90% of the time when there is cancer found in the non-sentinel nodes.
Interventions
DRUGIC Green
IC Green
Sponsors
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimate the Sensitivity of the Sentinel Lymph Node | 3 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IC Green Arm One arm only: Receives IC Green for testing of study objective
IC Green: IC Green | 430 |
| Total | 430 |
Baseline characteristics
| Characteristic | IC Green Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 137 Participants |
| Age, Categorical Between 18 and 65 years | 293 Participants |
| Age, Continuous | 51 years STANDARD_DEVIATION 28 |
| Region of Enrollment United States | 430 participants |
| Sex: Female, Male Female | 430 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 17 / 430 |
| serious Total, serious adverse events | 22 / 430 |
Outcome results
Primary
Estimate the Sensitivity of the Sentinel Lymph Node
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.
Time frame: 3 years
Population: Sensitivity of the sentinel lymph node
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IC Green (Indocyanine Green) Arm | Estimate the Sensitivity of the Sentinel Lymph Node | 418 Participants |