Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04665544
Status:
UNKNOWN
Last Update Posted:
2021-06-14
First Post:
2020-11-18
Brief Title:
Tracers for Endometrial Cancer Sentinel Node Labeling
Sponsor:
University Medical Centre Maribor
Organization:
University Medical Centre Maribor
Study Overview
Official Title:
Prospective Observational Study on Sentinel Node Biopsy Using Two Concurrent Labelling Techniques Radioactive Tracer WithWithout Blue Dye vs Indocyanine Green-ICG in Early-stage Endometrial Cancer Patients TESLA-1
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TESLA-1
Brief Summary:
Sentinel lymph node SLN biopsy is currently used in the management of vulvar and breast cancers as well as in malignant melanoma and is being intensively studied in patients with cervical and endometrial cancers The role of lymphadenectomy in the surgical management of early-stage endometrial cancer is still controversial The main reason to perform a SLN biopsy is to detect the lymph node that will be the first involved with metastatic disease in the nodal basin The SLN biopsy is performed after the SLN is located with the use of different tracers in a concept called SLN mapping Moreover SLN evaluation has been reported to improve the accuracy of lymph node staging due to SLN pathologic ultrastaging which includes multiple serial sectioning and immunohistochemical assessment The aim of this project is to conduct a multicentre prospective observational trial to compare two different SLN labelling methods radioactive tracer withwithout blue dye vs indocyanine green-ICG in the same patient and to evaluate the unilateral detection rate sensitivity number of detected SLN anatomical localisation of detected SLN and bilateral detection rate of SLN The main aim of the trial is the comparison of SLN mapping between two SLN labelling methods in the same patient The trial will answer a question whether a combination of labelling methods in the same patient increase importantly the sensitivity of SLN biopsy
The trial has a high potential to reach the calculated number of cases and thus bring in evidencedata that will be essential for future management of SLN biopsies in endometrial cancer
The trial has a high potential to reach the calculated number of cases and thus bring in evidencedata that will be essential for future management of SLN biopsies in endometrial cancer
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None