The Effect of Dose and Storage Conditions of Indocyanine Green on Efficacy and Cost in Sentinel Lymph Node Mapping in Gynecological Cancer (DOSTCONICG)

January 23, 2026 updated by: Ghanim Khatib, Cukurova University
This research will determine the impact of optimizing dosage and storage conditions for indocyanine green on health outcomes and will contribute to improving treatment processes in gynecological cancers. Ultrastaging will increase the detection of micrometastases. Furthermore, the cost impact of these optimizations will be evaluated. It will help develop more effective, safe, and cost-effective methods for sentinel lymph node mapping in gynecological cancers. Furthermore, significant savings in healthcare costs could be achieved.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Indocyanine Green (ICG) is a substance used in many areas of medicine, particularly in surgical procedures for vascular imaging, organ function assessment, and the treatment of various types of cancer. In recent years, this substance has also gained significant ground in gynecological cancers. The use of indocyanine green in gynecological cancers is particularly notable for its role in identifying cancer cells, performing lymph node biopsies, and performing minimally invasive surgeries.

Indocyanine green has become an important tool in the treatment of gynecological cancers, particularly in lymph node biopsies and minimally invasive surgeries. Its applications are increasingly expanding as it helps identify the path of cancer spread and enhances surgical precision. This substance allows surgeons to perform more accurate and effective interventions while also accelerating patient recovery.

Sentinel lymph node (SLN) mapping is increasingly used in gynecologic cancers as a less morbid staging method, an alternative to systematic pelvic and para-aortic lymphadenectomy. Numerous prospective studies have demonstrated the accuracy and reliability of the SLN technique, particularly in endometrial, cervical, and vulvar cancers. Indocyanine green (ICG), when used in conjunction with near-infrared fluorescence imaging, has become the most frequently used method due to its high sensitivity and bilateral detection rate.Patients diagnosed with endometrial, cervical, and vulvar cancer and scheduled for SLN mapping will be included in the study; potential confounding variables such as patient characteristics (age, BMI, comorbidities), tumor characteristics (histology, stage), surgical approach, and surgeon experience will also be considered in the analyses. Indocyanine green administration in gynecological cancers:

  1. Standard dose (1.25 mg/mL, 4 x 1 mL)
  2. A low-volume protocol (1 mL) may be tried in low-risk cases for minimal intervention, but signal may be reduced.
  3. A high-volume application (8-10 mL) may be preferred in obese or signal-deficient patients; signal strength may be increased.
  4. A high concentration (2.5 mg/mL) has been found effective in some studies, but should be used with caution due to the risk of suppressing ICG's own fluorescence.

Standard storage conditions:

Storage at 2-8°C (refrigerated) in dark glass vials protected from light and moisture.

Short-term storage at room temperature (15-25°C) after preparation is suitable. Use within 24 hours is recommended. In this study, sentinel lymph node mapping will be performed by injecting 1 cc of indocyanine green diluted with sterile water (25 mg + 20 mL water → 1.25 mg/mL) into the submucosa of the cervical os at the 3-9 o'clock positions.

Prepared ICGs will be stored in a dark environment at +4°C.

The data obtained will evaluate the effects of the dosage on mapping success and also reveal the potential effects of indocyanine green storage conditions on efficacy and cost. This study aims to contribute to the development of a safer, more effective, and more economical mapping method for gynecological cancers.

Parameters used in this study:

  • Age (years)
  • BMI (kg/m²)
  • Parity
  • Comorbidities (DM, HT, cardiac/AKI, COPD, renal failure)
  • Drug/allergy history (especially iodine/ICG/green dye)
  • Previous pelvic surgery/lymph node dissection/RT-CT history
  • ASA score
  • Cancer type: endometrium, cervix, vulva
  • Cancer stage (clinical and/or pathological)
  • Histology (endometrioid/serous/clearcell/squamous, etc.)
  • Tumor size (mm), depth of myometrial invasion (%) in endometrial cancers, LVSI (present/absent), depth of stromal invasion in cervical tumors, parametrial involvement, lesion location and size in the vulva
  • Need for reinjection: Present/Absent
  • Injection sites and plan: 3-9 line (superficial/deep) on the cervix, clitoris level on the vulva, labia majora; cervical injection standardization for the endometrium. -Storage conditions
  • Freshly prepared vs. stored for a certain period
  • Temperature: Room temperature vs. Refrigerator
  • Operative: Laparoscopic/Laparotomic
  • Operative duration (min), time to SLN (min)
  • Intraoperative complications (allergic reaction, tissue staining problems, etc.)
  • Number of lymph nodes: Total SLNs removed, SLNs per side
  • Anatomical distribution: Obturator, external/internal iliac, parametrial, presacral, etc.
  • Micro/macrometastasis, isolated tumor cells

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women who have endometrial or cervical or vulvar cancer

Description

Inclusion Criteria:

  • cervical cancer, endometrial cancer, vulvar cancer, using indocyanine green, sentinel lymph node dissection

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sentinel lymph node detection success rate associated with optimized indocyanine green (ICG) dosage and storage conditions.
Time Frame: Baseline (pre-procedure), perioperative/periprocedural period, and up to 24 weeks post-procedure.
Baseline (pre-procedure), perioperative/periprocedural period, and up to 24 weeks post-procedure.

Secondary Outcome Measures

Outcome Measure
Time Frame
Impact of optimizing indocyanine green (ICG) dosage and storage conditions on total procedural cost.
Time Frame: Baseline (pre-procedure) and up to 24 weeks post-procedure.
Baseline (pre-procedure) and up to 24 weeks post-procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2025

Primary Completion (Estimated)

August 3, 2026

Study Completion (Estimated)

September 3, 2026

Study Registration Dates

First Submitted

January 1, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 159/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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