Validation of the Sentinel Lymph Node Technique in Early-Stage Ovarian Cancer (Sentov Ii)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

IIS La Fe

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

8 Oct 2025 → ongoing

Decision date (initial)

2025-07-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Instituto de Salud Carlos III (ISCIII)

External identifiers

EU CT number

2024-520189-67-00

ClinicalTrials.gov

NCT06963268

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Efficacy, Safety

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 objectives 12

1. 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 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. Characterize the sample (through collection of baseline characteristics, medical history, tumor markers, intraoperative findings, surgical procedures, and immediate admission data).
4. 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 the sentinel lymph node procedure rate.
6. Determine the rate of "empty" sentinel lymph node detection.
7. Determine the detection rate of pelvic and/or paraaortic sentinel lymph nodes.
8. Identify the anatomical location of the sentinel lymph nodes.
9. Determine the number of detected lymph nodes.
10. Rate of overstaging with ultrastaging.
11. Complications related to the sentinel lymph node technique.
12. Complications related to lymphadenectomy.

Conditions and MedDRA coding

OVARIAN CANCER

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Signed informed consent prior to the performance of any procedure related to the clinical trial.
2. Female, 18 years of age or older at the time of inclusion.
3. Patients with an anatomopathological 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 8

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 18

1. Tumor size.
2. Tumor location.
3. Injection site.
4. Type of tracer used.
5. Injection-detection interval.
6. Detection method.
7. Anatomical location of the sentinel node.
8. Number of detected sentinel lymph nodes.
9. Number of detected lymph nodes.
10. Histological type of detected sentinel lymph nodes.
11. Degree of differentiation of detected sentinel lymph nodes.
12. Lymphovascular invasion of detected sentinel lymph nodes.
13. Ultrastaging of detected sentinel lymph nodes.
14. Binary classification of detected sentinel lymph nodes.
15. Histological result of detected sentinel lymph nodes.
16. FIGO stage of detected sentinel lymph nodes.
17. Surgical procedure performed.
18. Intraoperative complications.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

IIS La Fe

Sponsor organisation

IIS La Fe

Address

Avenida De Fernando Abril Martorell 106 A 7 Planta

City

Valencia

Postcode

46026

Country

Spain

Scientific contact point

Organisation

IIS La Fe

Contact name

Mónica Cebrián Pinar

Public contact point

Organisation

IIS La Fe

Contact name

Mónica Cebrián Pinar

Locations

1 EU/EEA country · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications