NCT07380698

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Oct 2025Sep 2026

Study Start

First participant enrolled

October 3, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2026

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

January 1, 2026

Last Update Submit

January 23, 2026

Conditions

Endometrial CancerVulvar CancersCervical CancerIndocyanine Green (ICG)

Keywords

endometrial cancervulvar cancerscervical cancers

Outcome Measures

Primary Outcomes (1)

  • Sentinel lymph node detection success rate associated with optimized indocyanine green (ICG) dosage and storage conditions.

    Baseline (pre-procedure), perioperative/periprocedural period, and up to 24 weeks post-procedure.

Secondary Outcomes (1)

  • Impact of optimizing indocyanine green (ICG) dosage and storage conditions on total procedural cost.

    Baseline (pre-procedure) and up to 24 weeks post-procedure.

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who have endometrial or cervical or vulvar cancer

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, 01000, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • Bedynska M, Szewczyk G, Klepacka T, Sachadel K, Maciejewski T, Szukiewicz D, Fijalkowska A. Sentinel lymph node mapping using indocyanine green in patients with uterine and cervical neoplasms: restrictions of the method. Arch Gynecol Obstet. 2019 May;299(5):1373-1384. doi: 10.1007/s00404-019-05063-6. Epub 2019 Feb 14.

    PMID: 30762108BACKGROUND

  • Laufer J, Scasso S, Papadia A. Impact of Indocyanine Green Dose on Sentinel Lymph Node Mapping in Cervical Cancer: A Systematic Review. Cancers (Basel). 2024 Sep 8;16(17):3107. doi: 10.3390/cancers16173107.

    PMID: 39272965BACKGROUND

  • Cibula D, Potter R, Planchamp F, Avall-Lundqvist E, Fischerova D, Haie Meder C, Kohler C, Landoni F, Lax S, Lindegaard JC, Mahantshetty U, Mathevet P, McCluggage WG, McCormack M, Naik R, Nout R, Pignata S, Ponce J, Querleu D, Raspagliesi F, Rodolakis A, Tamussino K, Wimberger P, Raspollini MR. The European Society of Gynaecological Oncology/European Society for Radiotherapy and Oncology/European Society of Pathology Guidelines for the Management of Patients With Cervical Cancer. Int J Gynecol Cancer. 2018 May;28(4):641-655. doi: 10.1097/IGC.0000000000001216.

    PMID: 29688967BACKGROUND

  • Abu-Rustum N, Yashar C, Arend R, Barber E, Bradley K, Brooks R, Campos SM, Chino J, Chon HS, Chu C, Crispens MA, Damast S, Fisher CM, Frederick P, Gaffney DK, Giuntoli R, Han E, Holmes J, Howitt BE, Lea J, Mariani A, Mutch D, Nagel C, Nekhlyudov L, Podoll M, Salani R, Schorge J, Siedel J, Sisodia R, Soliman P, Ueda S, Urban R, Wethington SL, Wyse E, Zanotti K, McMillian NR, Aggarwal S. Uterine Neoplasms, Version 1.2023, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2023 Feb;21(2):181-209. doi: 10.6004/jnccn.2023.0006.

    PMID: 36791750BACKGROUND

MeSH Terms

Conditions

Endometrial NeoplasmsVulvar NeoplasmsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesVulvar DiseasesUterine Cervical Diseases

Central Study Contacts

Ghanim Khatib, MD

CONTACT

+903223386060ghanim.khatib@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

January 1, 2026

First Posted

February 2, 2026

Study Start

October 3, 2025

Primary Completion (Estimated)

August 3, 2026

Study Completion (Estimated)

September 3, 2026

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

TU(1)