Clinical trial · Observational
The Effect of Dose and Storage Conditions of Indocyanine Green on Efficacy and Cost in Sentinel Lymph Node Mapping in Gynecological Cancer
NCT07380698CI-TRIAL-00102204DOSTCONICGrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Indocyanine Green (ICG) | — | UNRESOLVED | — |
| Vulvar Cancers | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sentinel lymph node detection success rate associated with optimized indocyanine green (ICG) dosage and storage conditions.
- timeFrame
- Baseline (pre-procedure), perioperative/periprocedural period, and up to 24 weeks post-procedure.
Secondary outcomes (1)
- measure
- Impact of optimizing indocyanine green (ICG) dosage and storage conditions on total procedural cost.
- timeFrame
- Baseline (pre-procedure) and up to 24 weeks post-procedure.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * cervical cancer, endometrial cancer, vulvar cancer, using indocyanine green, sentinel lymph node dissection Exclusion Criteria: \-
References
Publications (4)
- BACKGROUNDBedynska 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 30762108
- BACKGROUNDLaufer 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 39272965
- BACKGROUNDCibula 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 29688967
- BACKGROUNDAbu-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 36791750