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Sentinel node detection with 99Tc albumin nanocolloid and indocianine green (ICG) in patients with epithelial ovarian cancer in early stages. Pilot study.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505667-37-00
Acronym
MELISA II
Enrollment
62
Registered
2023-09-25
Start date
2023-10-06
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epithelial ovarian cancer in early stages.

Brief summary

Global detection rate of sentinel lymph node in patients having received both tracers.

Detailed description

Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by morphologic characteristics, pathology results, FIGO stage, biochemistry results and surgical approach., Detection rate and false negative rate according to each tracer, stratified by morphologic characteristics, pathology results, FIGO stage, biochemistry results and surgical approach., Detection rate of sentinel lymph node with 99mTC in the group of patients having received the tracer., Detection rate and false negative rate according to each detection technique used, stratified by morphologic characteristics, pathology results, FIGO stage, biochemistry results and surgical approach., Anatomical location of sentinel lymph node according to each tracer and assessment of concordance between them., Pathology ultrastadification evaluation., Chirurgic and post-operative complications, directly or indirectly associated to the use of the tracers

Interventions

DRUGTekcis 2-50 GBq generador de radionucleido
DRUG-
DRUGROTOP NanoHSA 500 microgramos equipo de reactivos para preparación radiofarmacéutica
DRUGUltra-TechneKow FM 2
DRUG15-43
DRUG00 GBq generador de radionúclido

Sponsors

Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Global detection rate of sentinel lymph node in patients having received both tracers.

Secondary

MeasureTime frame
Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by morphologic characteristics, pathology results, FIGO stage, biochemistry results and surgical approach., Detection rate and false negative rate according to each tracer, stratified by morphologic characteristics, pathology results, FIGO stage, biochemistry results and surgical approach., Detection rate of sentinel lymph node with 99mTC in the group of patients having received the tracer., Detection rate and false negative rate according to each detection technique used, stratified by morphologic characteristics, pathology results, FIGO stage, biochemistry results and surgical approach., Anatomical location of sentinel lymph node according to each tracer and assessment of concordance between them., Pathology ultrastadification evaluation., Chirurgic and post-operative complications, directly or indirectly associated to the use of the tracers

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026