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NCT Number: NCT06963268

Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)

This clinical trial investigates the sentinel lymph node (SLN) technique as a less invasive alternative to conventional lymphadenectomy in patients with early-stage ovarian cancer. The primary objective is to evaluate the effectiveness, safety, and diagnostic accuracy of the SLN approach in detecting lymphatic metastases. By assessing its negative predictive value, the study aims to determine whether the SLN technique can reliably replace systematic pelvic and paraaortic lymphadenectomy. If successful, this technique could minimize surgical morbidity, shorten hospitalization stays, and lower complication rates, ultimately improving patient outcomes.

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Key information

Conditions

Ovarian Neoplasms Adnexal Diseases 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 Site Ovarian Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

Location status: Recruiting

Location contact

Mónica Cebrián Coordinator Clinical Research Area

CONTACT

[email protected]

+34961246731

Víctor Lago Leal, physician

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed informed consent prior to the performance of any procedure related to the clinical trial.
  • Female, 18 years of age or older at the time of inclusion.
  • Patients with a histopathological diagnosis of malignant ovarian tumor in a deferred study (any epithelial histology), in apparent early stage FIGO I-II, proposed for staging surgery, or patients with suspected malignant ovarian tumor in apparent early stage FIGO I-II, who will undergo exploratory laparotomy and operative biopsy, and if positive, will undergo staging surgery.

Exclusion criteria

  • Failure to obtain informed consent or revocation of informed consent.
  • Under 18 years of age at the time of inclusion.
  • Previous history of vascular surgery on the aorta, vena cava, or pelvic vessels.
  • Previous pelvic or paraaortic lymphatic surgery.
  • Previous lymphoma.
  • Previous abdomino-pelvic tumor.
  • Previous allergy to Tc99 or ICG.
  • Pregnancy/Breastfeeding.

Patients who have signed informed consent but do not meet all inclusion criteria and none of the exclusion criteria will be considered as selection failures.

Treatment and study plan

Sentinel Node Technique

Procedure

A 0.2 ml (27 mBq) dose of 99mTc and 0.5 ml (1.25 mg/ml) of ICG is injected subperitoneally in the dorsal or ventral side of the pelvic infundibulum stump, and 0.2 ml (27 mBq) of 99mTc and 1 ml (1.25 mg/ml) of ICG intracervically. Sentinel nodes are located using the auditory signal from the gamma probe and visually via ICG staining with an infrared light system. After 30 minutes, all identified nodes are removed. Deferred histology applies ultra-staging for negative or micrometastatic nodes.

Primary outcomes

  1. Negative predictive value of the sentinel lymph node technique.

    Time frame: Postoperative (30 days +/- 10 days)

    To determine the negative predictive value of the sentinel lymph node technique for detecting lymph node metastases, using pelvic/aortic lymphadenectomy as the Gold Standard.

Secondary outcomes

  1. Concordance of Sentinel Lymph Node Technique vs. Lymphadenectomy

    Time frame: Postoperative (30 days +/- 10 days).

    Evaluate the degree of concordance (sensitivity, specificity, positive predictive value, and diagnostic accuracy) between the sentinel lymph node technique and pelvic/aortic lymphadenectomy (Gold Standard) for detecting lymph node metastasis.

  2. Characterize Sentinel Lymph Node Technique vs. Lymphadenectomy for Metastasis Detection

    Time frame: Intraoperative and postoperative (30 days +/- 10 days).

    Characterize the sentinel lymph node technique for detecting lymph node metastasis using pelvic/aortic lymphadenectomy as the Gold Standard in terms of sensitivity, specificity, positive and negative predictive value, positive and negative likelihood ratios, and effectiveness.

  3. Sample Characterization

    Time frame: Baseline visit and Intraoperative

    Characterize the sample (through collection of baseline characteristics, medical history, tumor markers, intraoperative findings, surgical procedures, and immediate admission data).

  4. Characterize Sentinel Lymph Node Technique Based On Site of Drug Injection

    Time frame: Intraoperative and postoperative (30 days +/- 10 days).

    Characterize the sentinel lymph node technique for detecting lymph node metastasis based on the site of drug injection, using lymphadenectomy as the Gold Standard, in terms of sensitivity, specificity, positive and negative predictive value, positive and negative likelihood ratios, and effectiveness.

  5. Determine Sentinel Lymph Node Procedure Rate

    Time frame: Intraoperative and postoperative (30 days +/- 10 days).

    Determine the sentinel lymph node procedure rate.

  6. Determine the rate of "empty" sentinel lymph node detection.

    Time frame: Postoperative (30 days +/- 10 days).

    Determine the rate of "empty" sentinel lymph node detection.

  7. Determine Pelvic and/or Paraaortic Sentinel Lymph Node Detection Rate

    Time frame: Intraoperative and postoperative (30 days +/- 10 days).

    Determine the detection rate of pelvic and/or paraaortic sentinel lymph nodes.

  8. Identify the anatomical location of the sentinel lymph nodes.

    Time frame: Intraoperative and postoperative (30 days +/- 10 days).

    Identify the anatomical location of the sentinel lymph nodes.

  9. Determine the number of detected lymph nodes.

    Time frame: Intraoperative and postoperative (30 days +/- 10 days).

    Determine the number of detected lymph nodes.

  10. Rate of overstaging with ultrastaging.

    Time frame: Postoperative (30 days +/- 10 days).

    Rate of overstaging with ultrastaging.

  11. Complications related to the sentinel lymph node technique

    Time frame: Intraoperative and postoperative (30 days +/- 10 days).

    Complications related to the sentinel lymph node technique.

  12. Complications related to lymphadenectomy.

    Time frame: Intraoperative and postoperative (30 days +/- 10 days).

    Complications related to lymphadenectomy.

Study contacts

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

Mónica Cebrián Coordinator Clinical Research Area

CONTACT

[email protected]

+34961246731

Sponsors and collaborators

Lead sponsor

Instituto de Investigacion Sanitaria La Fe

Other

Collaborators

  • Clinica Universidad de Navarra, Universidad de Navarra
  • Hospital Clinic of Barcelona
  • Hospital General Universitario Gregorio Marañon
  • Hospital Son Espases
  • Hospital Universitari de la Vall de Hebron
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Fundación Jiménez Díaz
  • Hospital Universitario La Fe
  • Hospital Universitario La Paz
  • Hospital of Navarra
  • Quirón Madrid University Hospital

Registry information

Acronym: SENTOV II

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 8, 2025
Registry last updated
Dec 19, 2025

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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