Sentinel Lymph Node in Early Ovarian Cancer (SENTOV)
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ClinicalTrials.gov Identifier: NCT03452982 |
Recruitment Status :
Completed
First Posted : March 2, 2018
Last Update Posted : October 18, 2019
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Condition or disease | Intervention/treatment | Phase |
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Ovarian Cancer | Other: sentinel node technique | Phase 2 |
The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with early stage ovarian cancer.
With this research study it will be evaluated the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Controlled, prospective, descriptive and not randomized |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Sentinel Lymph Node in Early Ovarian Cancer |
Actual Study Start Date : | March 23, 2018 |
Actual Primary Completion Date : | August 21, 2019 |
Actual Study Completion Date : | August 21, 2019 |

Arm | Intervention/treatment |
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Experimental: Patients with ovarian cancer
Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection
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Other: sentinel node technique
Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection. |
- Feasibility of performing the sentinel node technique (Detection rate) [ Time Frame: Intraoperative (day 0) ]The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with previous ovarian surgery injecting the tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.
- Rate of realization of the technique [ Time Frame: Intraoperative (day 0) ]
- Rate of realization of the technique [ Time Frame: After anatomopathological study (day 30) ]
- Anatomical location of the sentinel node(s) [ Time Frame: Intraoperative (day 0) ]Assessed by radiation (99Tc-nanocoloides) and staining with indocyanine green
- Anatomical location of the sentinel node(s) [ Time Frame: After anatomopathological study (day 30) ]Assessed by the pathologist
- Number of detected sentinel nodes [ Time Frame: Intraoperative (day 1) ]
- Number of detected sentinel nodes [ Time Frame: After anatomopathological study (day 30) ]
- Characterization of the sample by collecting baseline characteristics [ Time Frame: Screening (day 0) ]Age (years)
- Characterization of the sample by collecting baseline characteristics [ Time Frame: Screening (day 0) ]Weight (kilograms)
- Characterization of the sample by collecting baseline characteristics [ Time Frame: Screening (day 0) ]Height (centimeters)
- Characterization of the sample by collecting baseline characteristics [ Time Frame: Screening (day 0) ]BMI (kg/m^2)
- Characterization of the sample by collecting baseline characteristics [ Time Frame: Screening (day 0) ]Previous gynecological surgery and previous pathological anatomy
- Characterization of the sample by collecting tumor markers [ Time Frame: Day 0 ]Ca 125 and Ca 19.9.
- Characterization of the sample by collecting intraoperative findings [ Time Frame: Day 0 ]Ascites (milliliters)
- Characterization of the sample by collecting intraoperative findings [ Time Frame: Day 0 ]Tumor size (centimeters) of: right ovary, left ovary, right tube, left tube, uterus, pelvic nodes, para-aortic nodes, and tumor in upper hemiabdomen.
- Characterization of the sample by collecting surgical procedures [ Time Frame: Day 0 ]Hysterectomy, adnexectomy, appendectomy, peritonectomy / peritoneal biopsy, omentectomy, lymphadenectomy and blood transfusion (Realized or Unrealized)
- Characterization of the sample by collecting surgical procedures [ Time Frame: Day 0 ]Intraoperative complications
- Characterization of the sample by collecting surgical procedures [ Time Frame: Day 0 ]Result of intraoperative biopsy (unrealized, malignant, benign)
- Characterization of the sample by collecting surgical procedures [ Time Frame: Day 0 ]Estimated blood loss (milliliters)
- Characterization of the sample by collecting surgical procedures [ Time Frame: Day 0 ]Surgical time (minutes)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Informed consent signed previously to performing any procedure related to the clinical trial.
- Patients who are women 18 years of age or older at the moment of the randomization.
- Patients with anatomopathological diagnosis of malignant ovarian tumor in a deferred study proposals for staging surgery or patients with suspicious tumor of malignancy who are going to be subjected to exploratory lapaotomy or laparoscopy and operative biopsy, and in the case this is positive, surgery of staging will be performed .
Exclusion Criteria:
- Informed consent not obtained or withdraw.
- Benign result in extemporaneous study
- Previous history of vascular surgery in the aorta, cava or pelvic vessels
- Previous pelvic or para-aortic lymphadenectomy
- Previous lymphoma
- Previous abdomino-pelvic tumor
- Previous allergic reaction to indocyanine green
- Pregnancy / lactation
- Severe adherent syndrome

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452982
Spain | |
Hospital Universitario y Politécnico La Fe | |
Valencia, Spain, 46026 |
Principal Investigator: | Victor Lago | Instituto de Investigación Sanitaria La Fe |
Responsible Party: | Instituto de Investigacion Sanitaria La Fe |
ClinicalTrials.gov Identifier: | NCT03452982 |
Other Study ID Numbers: |
SENTOV |
First Posted: | March 2, 2018 Key Record Dates |
Last Update Posted: | October 18, 2019 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
SENTINEL LYMPH NODE |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |