Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer (Melisa-II)

February 5, 2026 updated by: Fundacion Clinic per a la Recerca Biomédica

Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and Indocyanine Green (ICG) in Patients With Epithelial Ovarian Cancer in Early Stages: Pilot Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional arm
All patients will receive an injection of ICG and an injection of 99mTc nanocolloid albumin
Diagnostic test: 99mTC nanocolloid albumin injection
All patients will receive an injection of both tracers in order to detect the sentinel lymph node
Diagnostic test: ICG injection
All patients will receive an injection of both tracers in order to detect the sentinel lymph node

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the diagnostic efficiency of both tracers in sentinel lymph node detection
Time Frame: Through study completion (an average of 36 months)
Global detection rate of sentinel lymph node in patients having received both tracers.
Through study completion (an average of 36 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to morphological characteristics
Time Frame: Through study completion (an average of 36 months)
Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by morphologic 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.
Time Frame: Through study completion (an average of 36 months)
Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by 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
Time Frame: Through study completion (an average of 36 months)
Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by 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.
Time Frame: Through study completion (an average of 36 months)
Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by 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
Time Frame: Through study completion (an average of 36 months)
Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by surgical approach
Through study completion (an average of 36 months)
Evaluation of anatomical distribution of 99mTC draining
Time Frame: Through study completion (an average of 36 months)
Detection rate of sentinel lymph node with 99mTC in the group of patients having received the tracer
Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to morphological characteristics.
Time Frame: Through study completion (an average of 36 months)
Detection rate and false negative rate of intraoperative detector gamma probe,stratified by morphologic characteristics.
Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to pathology results.
Time Frame: Through study completion (an average of 36 months)
Detection rate and false negative rate of intraoperative detector gamma probe,stratified by pathology results.
Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to FIGO stage.
Time Frame: Through study completion (an average of 36 months)
Detection rate and false negative rate of intraoperative detector gamma probe,stratified by FIGO stage.
Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to biochemistry results.
Time Frame: Through study completion (an average of 36 months)
Detection rate and false negative rate of intraoperative detector gamma probe,stratified by biochemistry results.
Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to surgical approach.
Time Frame: Through study completion (an average of 36 months)
Detection rate and false negative rate of intraoperative detector gamma probe,stratified by surgical approach.
Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative Near Infrared (NIR) camera in the display of ovarian lymphatic map according to morphological characteristics
Time Frame: Through study completion (an average of 36 months)
Detection rate and false negative rate of intraoperative NIR camera,stratified by morphological characteristics
Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to pathology results.
Time Frame: Through study completion (an average of 36 months)
Detection rate and false negative rate of intraoperative NIR camera,stratified by pathology results.
Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to FIGO stage.
Time Frame: Through study completion (an average of 36 months)
Detection rate and false negative rate of intraoperative NIR camera,stratified by FIGO stage.
Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to biochemistry results.
Time Frame: Through study completion (an average of 36 months)
Detection rate and false negative rate of intraoperative NIR camera,stratified by biochemistry results.
Through study completion (an average of 36 months)
Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to surgical approach.
Time Frame: Through study completion (an average of 36 months)
Detection rate and false negative rate of intraoperative NIR camera,stratified by surgical approach.
Through study completion (an average of 36 months)
Anatomical distribution of sentinel lymph node detected with ICG.
Time Frame: Through study completion (an average of 36 months)
Anatomical location of sentinel lymph node according to ICG.
Through study completion (an average of 36 months)
Anatomical distribution of sentinel lymph node detected with 99mTC albumin nanocolloid.
Time Frame: Through study completion (an average of 36 months)
Anatomical location of sentinel lymph node according to 99mTC albumin nanocolloid.
Through study completion (an average of 36 months)
Comparison of lymph node detection with both tracers.
Time Frame: Through study completion (an average of 36 months)
Assessment of concordance of sentinel lymph node anatomical location detected with each tracer.
Through study completion (an average of 36 months)
Evaluation of ultra-staging in micrometastases detection compared to conventional histology.
Time Frame: Through study completion (an average of 36 months)

Pathology ultra-staging evaluation.

The following classification will be considered according to the criteria of the American Joint Committee on Cancer (AJCC):

  • Macrometastases: tumor infiltration > 2 mm in maximum diameter.
  • Micrometastases: tumor infiltration between 0.2 and 2 mm in maximum diameter.
  • Isolated tumor cells or isolated cell group (CTA, GCA): clusters of cells smaller than 0.2 mm
Through study completion (an average of 36 months)
Evaluation of the complications associated with each technique.
Time Frame: Through study completion (an average of 36 months)
Chirurgic and post-operative complications, directly or indirectly associated to the use of the tracers.
Through study completion (an average of 36 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Clinic per a la Recerca Biomédica

Investigators

  • Principal Investigator: Berta Diaz-Feijoo, Physician, Hospital Clinic of Barcelona
  • Principal Investigator: Aureli Torné, Physician, Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

June 20, 2023

First Submitted That Met QC Criteria

July 6, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-505667-37-00

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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