Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT04051502
Eligibility Criteria:
Inclusion Criteria:
* Women undergoing surgery with the Gynecology Service at MSK.
* Women undergoing surgery for an adnexal mass without pre-operative suspicion of high stage disease, with or without a hysterectomy
°For this protocol, "suspected high stage disease" will be defined as any patient with radiologic or clinical evidence of ovarian cancer which has spread outside of the ovary. Thus, only patients with an adnexal mass, or bilateral adnexal masses, are eligible.
* Women in whom MIS surgery is converted to a laparotomy will not be excluded as both surgical approaches, MIS and open, will be utilized.
* Women \>/= 18 years of age
* Able to provide informed consent
* Albumin levels within normal range
Exclusion Criteria:
* Current non-GYN primary malignancy
* Prior or current history of uterine, cervical, peritoneal, or vulvovaginal malignancy
* Ongoing anticancer therapy
* Prior bilateral oophorectomy
* Known severe anaphylactic iodide allergy
* Known history of cirrhosis or other chronic liver disease, or women with hepatic dysfunction.
* Elevated transaminases (ALT, AST) and/or Alk Phos will be evaluated by the treating physician on a case by case basis.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04051502
Study Brief:
Protocol Section:
NCT04051502