Ovarian CancerEarly Phase 1NCT04051502
ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study
A Early Phase 1 study testing Method 1: Indocyanine green dye, Method 2: Indocyanine green dye and Method 3: Indocyanine green dye in people with Ovarian Cancer and Adnexal Mass, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Adnexal Mass
- What is being tested?
- Method 1: Indocyanine green dye, Method 2: Indocyanine green dye and Method 3: Indocyanine green dye
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 7 sitesUnited States
- Study dates
- 5 Aug 2019to 8 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, 11553
About this study
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.
- Conditions
- Ovarian Cancer, Adnexal Mass
- Being tested
- Method 1: Indocyanine green dye, Method 2: Indocyanine green dye, Method 3: Indocyanine green dye
- Keywords
- Ovarian Cancer, Adnexal Mass, Ovarian Sentinal Lymph Nodes, 19-271, Memorial Sloan Kettering Cancer Center, Sentinal Lymph Nodes, indocyanine green dye, ICG Dye
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Method 1: Indocyanine green dyeDrug
Also called ICG dye
Injection 4 mL of ICG dye directly into the fallopian tube (1 or more places is acceptable) only to the side where the adnexal mass is located
Method 2: Indocyanine green dyeDrug
Also called ICG dye
1mL of ICG injected at each of the four sites: only to the side where the adnexal mass is located
- Dorsal side of the IP ligament
- Ventral side of the IP ligament
- Dorsal side of the utero-ovarian ligament
- Ventral side of the utero-ovarian ligament
Method 3: Indocyanine green dyeDrug
Also called ICG dye
Injection of 2mL of ICG dye into the IP ligament pedicle after the adnexal mass has been removed. Only to the side where the adnexal mass is located
Method 3: Indocyanine green dyeDrug
Injection of 2mL of ICG dye into the IP ligament pedicle before the adnexal mass is removed.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | First group of 10 participants enrolled Receives: Drug: Method 1: Indocyanine green dye |
| Group 2 | Experimental | Second group of 10 participants enrolled Receives: Drug: Method 2: Indocyanine green dye |
| Group 3 | Experimental | Third group of 10 participants enrolled Receives: Drug: Method 3: Indocyanine green dye |
| Group 4 | Experimental | Fourth group of 10 participants enrolled Receives: Drug: Method 3: Indocyanine green dye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and location of ovarian sentinel lymph nodes visually identified after injection of ICG dye via one of three tested methods.
Evaluate for dye uptake in the regional lymphatic channels, and in the pelvic and para-aortic nodes using infrared imaging.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start5 Aug 2019
- Primary completion8 Dec 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ginger Gardner, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051502
- Sponsor's protocol ID
- 19-271
- Status last verified
- Dec 2025
- First submitted
- 5 Aug 2019
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04051502
- Acronym / sponsor ID
- 19-271
- Conditions
- Ovarian Cancer, Adnexal Mass
- Keywords
- Ovarian Cancer, Adnexal Mass, Ovarian Sentinal Lymph Nodes, 19-271, Memorial Sloan Kettering Cancer Center, Sentinal Lymph Nodes, indocyanine green dye, ICG Dye
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Method 1: Indocyanine green dyeFirst group of 10 participants enrolled |
| Group 2 | Experimental | Drug: Method 2: Indocyanine green dyeSecond group of 10 participants enrolled |
| Group 3 | Experimental | Drug: Method 3: Indocyanine green dyeThird group of 10 participants enrolled |
| Group 4 | Experimental | Drug: Method 3: Indocyanine green dyeFourth group of 10 participants enrolled |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Method 1: Indocyanine green dyeAlso: ICG dyeInjection 4 mL of ICG dye directly into the fallopian tube (1 or more places is acceptable) only to the side where the adnexal mass is located | Drug | Group 1 |
| Method 2: Indocyanine green dyeAlso: ICG dye1mL of ICG injected at each of the four sites: only to the side where the adnexal mass is located * Dorsal side of the IP ligament * Ventral side of the IP ligament * Dorsal side of the utero-ovarian ligament * Ventral side of the utero-ovarian ligament | Drug | Group 2 |
| Method 3: Indocyanine green dyeAlso: ICG dyeInjection of 2mL of ICG dye into the IP ligament pedicle after the adnexal mass has been removed. Only to the side where the adnexal mass is located | Drug | Group 3 |
| Method 3: Indocyanine green dyeInjection of 2mL of ICG dye into the IP ligament pedicle before the adnexal mass is removed. | Drug | Group 4 |
Primary outcome
Number and location of ovarian sentinel lymph nodes visually identified after injection of ICG dye via one of three tested methods.
Time frame: 1 year
Evaluate for dye uptake in the regional lymphatic channels, and in the pelvic and para-aortic nodes using infrared imaging.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ginger Gardner, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Method 1: Indocyanine green dye, Method 2: Indocyanine green dye and Method 3: Indocyanine green dye in people with Ovarian Cancer and Adnexal Mass, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and location of ovarian sentinel lymph nodes visually identified after injection of ICG dye via one of three tested methods. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.