NCT05937620

Brief Summary

Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Sep 2023

Typical duration for not_applicable

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 Progress87%
Sep 2023Oct 2026

First Submitted

Initial submission to the registry

June 20, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

June 20, 2023

Last Update Submit

February 5, 2026

Conditions

Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the diagnostic efficiency of both tracers in sentinel lymph node detection

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

    Through study completion (an average of 36 months)

Secondary Outcomes (21)

  • Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to morphological characteristics

    Through study completion (an average of 36 months)

  • Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to pathology results.

    Through study completion (an average of 36 months)

  • Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to International Federation of Gynecology and Obstetrics (FIGO) stage

    Through study completion (an average of 36 months)

  • Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to biochemistry results.

    Through study completion (an average of 36 months)

  • Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to surgical approach

    Through study completion (an average of 36 months)

  • +16 more secondary outcomes

Study Arms (1)

Interventional arm

EXPERIMENTAL

All patients will receive an injection of ICG and an injection of 99mTc nanocolloid albumin

Diagnostic Test: 99mTC nanocolloid albumin injectionDiagnostic Test: ICG injection

Interventions

99mTC nanocolloid albumin injectionDIAGNOSTIC_TEST

All patients will receive an injection of both tracers in order to detect the sentinel lymph node

Interventional arm
ICG injectionDIAGNOSTIC_TEST

All patients will receive an injection of both tracers in order to detect the sentinel lymph node

Interventional arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with adnexal mass diagnosed with high suspicion of malignancy that will undergo intraoperative biopsy or patients with already diagnosed epithelial cancer in early stages in a previous surgery and confirmed by pathology with complete staging indicated.
  • Absence of retroperitoneal ganglionary affectation and metastatic disease evaluated by preoperative imaging techniques.
  • Signing of informed consent by the patient or relative in charge.
  • Women with childbearing potential must compromise to use highly effective contraceptive methods (partner vasectomized, sexual abstinence) until the end of the study (last study visit).

You may not qualify if:

  • Patients \<18 years
  • Pregnancy or breastfeeding
  • Epithelial ovarian tumors stage FIGO III or IV.
  • Impossibility to obtain a biopsy from the tumor.
  • History of previous vascular surgery (cava vein, aorta, iliac blood vessels) or radiotherapy in pelvic or para-aortic area.
  • Sentinel lymph node biopsy will not be performed if intraoperative histologic study shows a benign ovarian tumor, low malignancy potential tumor or expansive mucinous histology.
  • Patient not able to undergo surgery.
  • Hypersensitivity to active principle, to sodium iodide or iodine allergy.
  • Patients with clinic hyperthyroidism, thyroid autonomous adenomas or focal and diffused autonomous alteration of thyroid gland

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laura Burunat

Barcelona, Catalonia, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Berta Diaz-Feijoo, Physician

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

  • Aureli Torné, Physician

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Burunat, Graduate

CONTACT

0034 932275400burunat@recerca.clinic.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2023

First Posted

July 10, 2023

Study Start

September 1, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

ES(1)