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ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status

Active, not recruiting

Conditions

Ovarian Cancer
Adnexal Mass

Treatments

Drug: Method 3: Indocyanine green dye
Drug: Method 2: Indocyanine green dye
Drug: Method 1: Indocyanine green dye

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of this study is to find out how well ovarian sentinel lymph nodes (SLNs) can be identified with indocyanine green (ICG) dye during risk-reducing ovarian surgery.

Enrollment

48 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

48 participants in 4 patient groups

Group 1
Description:
First group of 10 participants enrolled
Treatment:
Drug: Method 1: Indocyanine green dye
Group 2
Description:
Second group of 10 participants enrolled
Treatment:
Drug: Method 2: Indocyanine green dye
Group 3
Description:
Third group of 10 participants enrolled
Treatment:
Drug: Method 3: Indocyanine green dye
Drug: Method 3: Indocyanine green dye
Group 4
Description:
Fourth group of 10 participants enrolled
Treatment:
Drug: Method 3: Indocyanine green dye
Drug: Method 3: Indocyanine green dye

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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