Ovarian NeoplasmsPhase 3SENTOV IINCT06963268
Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)
A Phase 3 study testing Sentinel Node Technique in people with Ovarian Neoplasms, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Sentinel Node Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 10 Nov 2025to Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mónica Cebrián Coordinator Clinical Research Area contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, 46026
Mónica Cebrián Coordinator Clinical Research Area, +34961246731, investigacion_clinica@iislafe.es
Víctor Lago Leal, physician
About this study
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.
- Conditions
- Ovarian Neoplasms
- Being tested
- Sentinel Node Technique
- Keywords
- Sentinel Node Technique
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Node TechniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Women >18, with confirmed early-stage ovarian cancer, undergoing staging surgery. | Experimental | 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. Receives: Procedure: Sentinel Node Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative predictive value of the sentinel lymph node technique.
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.
Measured: Postoperative (30 days +/- 10 days)
Secondary outcomes (12)
Concordance of Sentinel Lymph Node Technique vs. Lymphadenectomy
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.
Measured: Postoperative (30 days +/- 10 days).
Characterize Sentinel Lymph Node Technique vs. Lymphadenectomy for Metastasis Detection
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.
Measured: Intraoperative and postoperative (30 days +/- 10 days).
Sample Characterization
Characterize the sample (through collection of baseline characteristics, medical history, tumor markers, intraoperative findings, surgical procedures, and immediate admission data).
Measured: Baseline visit and Intraoperative
Characterize Sentinel Lymph Node Technique Based On Site of Drug Injection
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.
Measured: Intraoperative and postoperative (30 days +/- 10 days).
Determine Sentinel Lymph Node Procedure Rate
Determine the sentinel lymph node procedure rate.
Measured: Intraoperative and postoperative (30 days +/- 10 days).
Determine the rate of "empty" sentinel lymph node detection.
Determine the rate of "empty" sentinel lymph node detection.
Measured: Postoperative (30 days +/- 10 days).
Determine Pelvic and/or Paraaortic Sentinel Lymph Node Detection Rate
Determine the detection rate of pelvic and/or paraaortic sentinel lymph nodes.
Measured: Intraoperative and postoperative (30 days +/- 10 days).
Identify the anatomical location of the sentinel lymph nodes.
Identify the anatomical location of the sentinel lymph nodes.
Measured: Intraoperative and postoperative (30 days +/- 10 days).
Determine the number of detected lymph nodes.
Determine the number of detected lymph nodes.
Measured: Intraoperative and postoperative (30 days +/- 10 days).
Rate of overstaging with ultrastaging.
Rate of overstaging with ultrastaging.
Measured: Postoperative (30 days +/- 10 days).
Complications related to the sentinel lymph node technique
Complications related to the sentinel lymph node technique.
Measured: Intraoperative and postoperative (30 days +/- 10 days).
Complications related to lymphadenectomy.
Complications related to lymphadenectomy.
Measured: Intraoperative and postoperative (30 days +/- 10 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start10 Nov 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Controlled, prospective, descriptive and not randomized
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Fe, Hospital Clinic of Barcelona, Hospital Universitario 12 de Octubre, Hospital Universitario La Paz, Hospital General Universitario Gregorio Marañon, Quirón Madrid University Hospital, Hospital of Navarra, Hospital Son Espases, Hospital Universitari de la Vall de Hebron, Hospital Universitario Fundación Jiménez Díaz, Clinica Universidad de Navarra, Universidad de Navarra
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963268
- Sponsor's protocol ID
- SENTOV II
- Acronym
- SENTOV II
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lago V, Rey I, Diaz-Feijoo B, Torrent A, Tejerizo A, Muruzabal JC, Veiga-Fernandez A, Utrilla-Layna J, Chacon E, Angeles MA, Diestro MD, Sainz de la Cuesta R, Padilla-Iserte P, Montero B, Dawid De Vera T, Vera V, Domingo S. Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II). Int J Gynecol Cancer. 2026 Jul;36(7):102821. doi: 10.1016/j.ijgc.2025.102821. Epub 2025 Nov 21.
PubMed 41763980
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)
- ClinicalTrials.gov ID
- NCT06963268
- Acronym / sponsor ID
- SENTOV II / SENTOV II
- Conditions
- Ovarian Neoplasms
- Keywords
- Sentinel Node Technique
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Collaborators
- Hospital Universitario La Fe, Hospital Clinic of Barcelona, Hospital Universitario 12 de Octubre, Hospital Universitario La Paz, Hospital General Universitario Gregorio Marañon, Quirón Madrid University Hospital, Hospital of Navarra, Hospital Son Espases, Hospital Universitari de la Vall de Hebron, Hospital Universitario Fundación Jiménez Díaz, Clinica Universidad de Navarra, Universidad de Navarra
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Controlled, prospective, descriptive and not randomized
| Arm | Type | Receives |
|---|---|---|
| Women >18, with confirmed early-stage ovarian cancer, undergoing staging surgery. | Experimental | Procedure: Sentinel Node TechniqueA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel Node TechniqueA 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. | Procedure or surgery | Women >18, with confirmed early-stage ovarian cancer, undergoing staging surgery. |
Primary outcome
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.
12 secondary outcomes
Concordance of Sentinel Lymph Node Technique vs. Lymphadenectomy
Time frame: Postoperative (30 days +/- 10 days).
Characterize Sentinel Lymph Node Technique vs. Lymphadenectomy for Metastasis Detection
Time frame: Intraoperative and postoperative (30 days +/- 10 days).
Sample Characterization
Time frame: Baseline visit and Intraoperative
Characterize Sentinel Lymph Node Technique Based On Site of Drug Injection
Time frame: Intraoperative and postoperative (30 days +/- 10 days).
Determine Sentinel Lymph Node Procedure Rate
Time frame: Intraoperative and postoperative (30 days +/- 10 days).
Determine the rate of "empty" sentinel lymph node detection.
Time frame: Postoperative (30 days +/- 10 days).
Determine Pelvic and/or Paraaortic Sentinel Lymph Node Detection Rate
Time frame: Intraoperative and postoperative (30 days +/- 10 days).
Identify the anatomical location of the sentinel lymph nodes.
Time frame: Intraoperative and postoperative (30 days +/- 10 days).
Determine the number of detected lymph nodes.
Time frame: Intraoperative and postoperative (30 days +/- 10 days).
Rate of overstaging with ultrastaging.
Time frame: Postoperative (30 days +/- 10 days).
Complications related to the sentinel lymph node technique
Time frame: Intraoperative and postoperative (30 days +/- 10 days).
Complications related to lymphadenectomy.
Time frame: Intraoperative and postoperative (30 days +/- 10 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Derived from this study: PubMed 41763980Lago V, Rey I, Diaz-Feijoo B, Torrent A, Tejerizo A, Muruzabal JC, Veiga-Fernandez A, Utrilla-Layna J, Chacon E, Angeles MA, Diestro MD, Sainz de la Cuesta R, Padilla-Iserte P, Montero B, Dawid De Vera T, Vera V, Domingo S. Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II). Int J Gynecol Cancer. 2026 Jul;36(7):102821. doi: 10.1016/j.ijgc.2025.102821. Epub 2025 Nov 21.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mónica Cebrián Coordinator Clinical Research Area contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sentinel Node Technique in people with Ovarian Neoplasms, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mónica Cebrián Coordinator Clinical Research Area (+34961246731, investigacion_clinica@iislafe.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative predictive value of the sentinel lymph node technique. (time frame: Postoperative (30 days +/- 10 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06963268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.