Sentinel lymph node assessment in ovarian cancer. Lymphatic mapping with two tracers and intraoperative lymphoscintigraphy.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005546-42-ES

Enrollment

Registered

2021-07-05

Start date

2021-06-21

Completion date

Unknown

Last updated

2021-07-12

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

Conditions

Sentinel lymph node in ovarian cancer MedDRA version: 20.0 Level: LLT Classification code 10072873 Term: Sentinel lymph node mapping System Organ Class: 100000004848

Interventions

Trade Name: Verdye Pharmaceutical Form: Powder for injection INN or Proposed INN: indocyanine green CAS Number: 3599-32-4 Other descriptive name: INDOCYANINE GREEN Concentration unit: mg/ml milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - -Patients with adnexal mass of high suspicion of malignancy requiring intra-operative biopsy. -Patients with diagnostic of epithelian ovarian cancer (EOC) in initial stage requiring lymphoid mapping and lymphadenectomy - Lack of radiologic retroperitoneal or metastacic disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 62 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 62

Exclusion criteria

Exclusion criteria: Age <18 - Pregnancy or breastfeeding - EOC figo stages III or IV. - Biopsy unavailability. - Prior vascular surgery, lymphadenectomy or radiotherapy in the region - Non-surgical patient. - Known allergy to study drugs

Design outcomes

Primary

Measure	Time frame
Main Objective: Identification of sentinel lymph node in ovarian cancer and assessment of its diagnostic effectiveness in lymphoid mapping using two tracers and intra operative scintigraphy;Secondary Objective: Lymph mapping in initial stage ovarian cancer patients for each tracer (99mTc-albumin nanocolloid and ICG). Usefulness of intra-operative scintygraphy gamma-detecting probe and NIR camera in ovalian lymph mapping. - Rate of sentinel node identification with each tracer. - False negative rate in metastatic patients. - micrometastasis detection rate .;Primary end point(s): Existencia de drenaje linfático, definida como la visualización, como mínimo, de un ganglio linfático a nivel pélvico o paraórtico;Timepoint(s) of evaluation of this end point: 1 hour	—

Measure

Time frame

Main Objective: Identification of sentinel lymph node in ovarian cancer and assessment of its diagnostic effectiveness in lymphoid mapping using two tracers and intra operative scintigraphy;Secondary Objective: Lymph mapping in initial stage ovarian cancer patients for each tracer (99mTc-albumin nanocolloid and ICG). Usefulness of intra-operative scintygraphy gamma-detecting probe and NIR camera in ovalian lymph mapping. - Rate of sentinel node identification with each tracer. - False negative rate in metastatic patients. - micrometastasis detection rate .;Primary end point(s): Existencia de drenaje linfático, definida como la visualización, como mínimo, de un ganglio linfático a nivel pélvico o paraórtico;Timepoint(s) of evaluation of this end point: 1 hour

—

Secondary

Measure	Time frame
Secondary end point(s): Time to drainage visualization: minutes since injection until intra-node observation. o Assessment of drainage path: pelvic, paraortic, both. o Number of sentinel nodes with biopsy o Surgical/post-surgical complications o duration of admission (days) o FIGO stage surgical;Timepoint(s) of evaluation of this end point: 30 days	—

Countries

Spain

Contacts

Public ContactICGON

Hospital Clinic

34932275400

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026