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NCT Number: NCT05937620

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

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

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Key information

Conditions

Ovarian Epithelial Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Laura Burunat

Barcelona, Catalonia, 08036, Spain

Location status: Recruiting

Location contact

Laura B Burunat

CONTACT

[email protected]

0034932275400 ext. 4198

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

99mTC nanocolloid albumin injection

Diagnostic Test

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

ICG injection

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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

  21. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Burunat, Graduate

CONTACT

[email protected]

0034 932275400 ext. 4198

Sponsors and collaborators

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Other

Registry information

Official study title

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

Acronym: Melisa-II

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2023
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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