Using sentinel node screening for endometrial cancer

Sentinel Node in Endometrial Cancer by Detection of Hybrid ([99mTc] Tc-albumin Nanocoloid-ICG). A Comparative Pilot Study Between the Lymphatic Map Derived From the Cervical Puncture Versus Myometrial

This study is testing whether a new way to find lymph nodes can help people with high-risk endometrial cancer by using a special dye and a radiotracer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Fundacion Clinic per a la Recerca Biomédica (other)
• Locations: 1 site (Barcelona)
• Trial ID: NCT04492995 on ClinicalTrials.gov

What this trial studies

This Phase II, open-label, randomized pilot study aims to evaluate the effectiveness of sentinel node screening in patients with high-risk endometrial cancer. Participants will be randomly assigned to receive either a radiotracer via cervical administration or a combination of the radiotracer with Indocyanine Green. The study will include 70 patients, who will be monitored for up to one month after the last administration of the radiotracer. The goal is to assess the feasibility and potential benefits of these approaches in identifying sentinel lymph nodes.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with a histological diagnosis of high-risk endometrial cancer.

Not a fit: Patients with pregnancy, suspected metastatic disease, or previous pelvic surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of lymph node assessment in endometrial cancer, potentially leading to better treatment outcomes.

How similar studies have performed: Other studies have shown promise in using sentinel node techniques for various cancers, suggesting potential success for this approach in endometrial cancer.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years.
2. Histological diagnosis of endometrial cancer with criteria of high risk according to the following criteria: - unfavorable histology according to FIGO (adenocarcinoma serous, clear cell, or carcinosarcoma) - nuclear grade 3 - suspected myometrial invasion\> 50% by resonance magnetic (MR) or transvaginal ultrasound
3. Women of childbearing age should have a transvaginal ultrasound who rule out pregnancy and must commit to using methods highly effective contraceptives (vasectomized couple and sexual abstinence) until the hysterectomy is performed.
4. Patient who gives written informed consent.

Exclusion Criteria:

1. Pregnancy or lactation.
2. Suspected lymph node or distant metastatic disease in the preoperative study.
3. History of previous surgery or radiotherapy in the pelvic and paraortic lymphatic drainage areas or nodal involvement of any other etiology.
4. Body mass index (BMI) greater than 45 Kg / m2.
5. Patients who, in the researcher's opinion, are not suitable for participate, regardless of reason, including medical or clinical, or participants potentially at risk of not comply with the study procedures.
6. Known hypersensitivity to some of the active substances or excipients from RT or ICG (including previous history of hypersensitivity to products containing human albumin).
7. Hypersensitivity to sodium iodide.
8. Patients allergic to iodine.
9. Patients with clinical hyperthyroidism, thyroid adenomas autonomic and diffuse focal and autonomic disturbances of the gland thyroid.

Where this trial is running

Barcelona

• Hospital Clínic de Barcelona — Barcelona, Spain (RECRUITING)

Study contacts

• Principal investigator: Pilar Paredes, MD — Hospital Clinic of Barcelona
• Study coordinator: Pilar Paredes, MD

Conditions: Endometrial Cancer