Gynecologic SurgeryNCT05071976
A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery
A study testing ICG-NIR angiography in people with Gynecologic Surgery, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The objective of this study is to assess whether Near-Infrared Fluorescence/NIR Imaging perfusion alters intraoperative management of the flap or of the participant wound bed. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Surgery
- What is being tested?
- ICG-NIR angiography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 7 sitesUnited States
- Study dates
- 24 Sep 2021to 24 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 a pelvic reconstruction procedure after radical gynecologic surgery for any indication at MSK.
- Age ≥18 years.
Who cannot join
- Women with hepatic dysfunction as evidenced by elevated transaminases (two times the upper limit of normal).
- Women with a history of cirrhosis or other chronic liver disease.
- Women with a documented severe or life threatening allergy to iodine.
- Women with an allergy to ICG or severe allergy to iodinated contrast.
- Women undergoing any free flap (non-pedicled) reconstruction.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Consent and Followup)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Suffolk - Commack (Consent and Followup)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Consent and Followup)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Consent and Followup)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent and Followup)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent and Followup)
Rockville Centre, New York, 11553
About this study
Official title: Near-infrared FluORescencE Assessment of Myocutaneous Flap Microperfusion for Gynecologic RecONstrucTion (FOREFRONT): A Pilot Study
The objective of this study is to assess whether Near-Infrared Fluorescence/NIR Imaging perfusion alters intraoperative management of the flap or of the participant wound bed.
- Conditions
- Gynecologic Surgery
- Being tested
- ICG-NIR angiography
- Keywords
- gynecologic surgery, abdominal wall reconstruction procedure, pelvic reconstruction procedure, Near-Infrared Fluorescence Imaging, ICG, 21-349, Memorial Sloan Kettering Cancer Center
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG-NIR angiographyDiagnostic test
Capture NIR video of flap site beginning at time of ICG injection. At time of subjective peak intensity, capture video of flap and recipient wound bed. Measure rate of ICG egress from the global flap at 60, 120, and 180 seconds after initial dye injection from intraoperative video
| Study group | Role | What they receive |
|---|---|---|
| Participants undergoing a pelvic or abdominal wall reconstruction procedure | Experimental | Women undergoing a pelvic or abdominal wall reconstruction procedure after radical gynecologic surgery for any indication at Memorial Sloan Kettering Cancer Center Receives: Diagnostic Test: ICG-NIR angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans
The primary purpose of this study is to introduce ICG-NIR angiography in abdominopelvic skin and myocutaneous pedicle flap-based reconstruction during gynecologic oncology surgery and determine the percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start24 Sep 2021
- Primary completion24 Oct 2027 (estimated)
- Study completion24 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic SurgeryStudies 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadeem Abu-Rustum, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071976
- Sponsor's protocol ID
- 21-349
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2021
- Last updated
- 2 Nov 2026
- Results posted
- No
- 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-infrared FluORescencE Assessment of Myocutaneous Flap Microperfusion for Gynecologic RecONstrucTion (FOREFRONT): A Pilot Study
- ClinicalTrials.gov ID
- NCT05071976
- Acronym / sponsor ID
- 21-349
- Conditions
- Gynecologic Surgery
- Keywords
- gynecologic surgery, abdominal wall reconstruction procedure, pelvic reconstruction procedure, Near-Infrared Fluorescence Imaging, ICG, 21-349, Memorial Sloan Kettering Cancer Center
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 24 Oct 2027 (estimated)
- Study completion
- 24 Oct 2027 (estimated)
- First posted
- 8 Oct 2021 (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 objective of this study is to assess whether Near-Infrared Fluorescence/NIR Imaging perfusion alters intraoperative management of the flap or of the participant wound bed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants undergoing a pelvic or abdominal wall reconstruction procedure | Experimental | Diagnostic Test: ICG-NIR angiographyWomen undergoing a pelvic or abdominal wall reconstruction procedure after radical gynecologic surgery for any indication at Memorial Sloan Kettering Cancer Center |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women undergoing a pelvic reconstruction procedure after radical gynecologic surgery for any indication at MSK.
- Age ≥18 years.
Key exclusion criteria (5 listed)
- Women with hepatic dysfunction as evidenced by elevated transaminases (two times the upper limit of normal).
- Women with a history of cirrhosis or other chronic liver disease.
- Women with a documented severe or life threatening allergy to iodine.
- Women with an allergy to ICG or severe allergy to iodinated contrast.
- Women undergoing any free flap (non-pedicled) reconstruction.
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 |
|---|---|---|
| ICG-NIR angiographyCapture NIR video of flap site beginning at time of ICG injection. At time of subjective peak intensity, capture video of flap and recipient wound bed. Measure rate of ICG egress from the global flap at 60, 120, and 180 seconds after initial dye injection from intraoperative video | Diagnostic test | Participants undergoing a pelvic or abdominal wall reconstruction procedure |
Primary outcome
Percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans
Time frame: Up to 24 months
The primary purpose of this study is to introduce ICG-NIR angiography in abdominopelvic skin and myocutaneous pedicle flap-based reconstruction during gynecologic oncology surgery and determine the percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- 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.
Nadeem Abu-Rustum, 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 study testing ICG-NIR angiography in people with Gynecologic Surgery, 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 2 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans (time frame: Up to 24 months). 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 2 Nov 2026.