Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* Primary diagnosis of invasive epithelial ovarian cancer FIGO stage IIB-IV (IV only if resectable metastasis in pleura, liver, spleen, and/or abdominal wall)
* Macroscopic complete resection
* Age: 18 - 75 years
* Patients who have given their signed and written informed consent
* Good performance status (ECOG 0/1)

Exclusion Criteria:

* Non epithelial ovarian malignancies and borderline tumors
* Intraoperative clinically suspicious lymph nodes (bulky nodes)
* Secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or with any signs of relapse or activity.
* Recurrent ovarian cancer
* Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy
* Diseases of the lymph system (including lymph edema of unknown origin)
* Clinical relevant dysfunctions of blood clotting (including medicamentous conditioned reasons, e.g. ASS, if not stopped at least 7 days prior to surgery)
* Any significant medical reasons, age or performance status that will not allow to perform the study procedures (estimation of investigator)
* Prior retroperitoneal lymph node dissection (systematic or sampling)
* Pregnancy
* Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent
* Any reasons interfering with regular follow-up
B: Inclusion Criteria:

* Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
* Patients with Histologically confirmed stage IA1 (with lymph vascular invasion), stage IA2, or stage IB1 disease
* Patients undergoing either a Type II or III radical hysterectomy (Piver Classification)
* Patients with adequate bone marrow, renal and hepatic function:
* ECOG Performance Status of 0 or 1.
* Patient must be suitable candidates for surgery.
* Patients who have signed an approved Informed Consent
* Patients with a prior malignancy allowed if \> 5 years ago with no current evidence of disease
* Females, aged 18 years or older
* Negative serum pregnancy test within \<30 days of surgery in pre-menopausal women and women \< 2 years after the onset of menopause

Exclusion Criteria:

* Any histology other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
* Tumor size greater than 4 cm;
* FIGO stage II-IV;
* Patients with a history of pelvic or abdominal radiotherapy;
* Patients who are pregnant;
* Patients with contraindications to surgery;
* Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes \> 2cm; or histologically positive lymph nodes
* Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
* Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
* Patient compliance and geographic proximity that do not allow adequate follow-up
C: 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.
D: Inclusion Criteria:

1. Females, over 18 years, with histologically confirmed primary epithelial cancer of the endometrium of any cell type or uterine carcinosarcoma (mixed malignant mullerian tumour);
2. Clinically stage I disease (disease confined to body of uterus);
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
4. Signed written informed consent;
5. Participant must meet criteria for a laparoscopic or robotic surgical approach as determined by the treating physician (e.g. suitable for TH BSO, ability to tolerate Trendelenberg positioning)
6. All available clinical evidence (physical examination findings, or medical imaging such as CT, MRI or ultrasound) demonstrates no evidence of extrauterine disease
7. Myometrial Invasion on MRI of not more than 50%. (Only if participant is \<45yo, has ONLY Grade 1 EAC and wishes to retain their ovaries).
8. Negative (serum or urine) pregnancy test ≤ 30 days of surgery in pre-menopausal women and women \< 2 years after the onset of menopause.

Exclusion Criteria:

1. Evidence of extrauterine disease (apparent involvement of cervix, vagina, parametria, adnexa, lymph nodes, bladder, bowel or distant sites) by clinical examination and/or through medical imaging.
2. Enlarged retroperitoneal pelvic and/or aortic lymph nodes (\>1 cm) on medical imaging;
3. Estimated life expectancy of less than 6 months;
4. Patients who have absolute contraindications for adjuvant radiotherapy and/or chemotherapy;
5. Patients who have previously received radiation treatment to the pelvis
6. Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
7. Patient compliance and geographic proximity that do not allow adequate follow-up;
8. Patients with allergy to Indocyanine Green (ICG)
9. Patients who have had previous retroperitoneal surgery
10. Patients who require a retroperitoneal (pelvic +/- para-aortic) lymph node dissection (lymphadenectomy)
11. Other prior malignancies \<5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma of the breast insitu
12. Uterine perforation during endometrial tissue sampling

Answer: C