Clinical trial · Interventional
Lymphoseek as Lymphoid Tissue Targeting Agent in Patients With Cancer of the Endometrium
A Phase I, Prospective, Open-Label, Comparison Study of Lymphoseek® and Vital Blue Dye as Lymphoid Tissue Targeting Agents in Patients With Known Cancer of the the Endometrium Who Are Undergoing Lymph Node Dissection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Part of standard treatment for endometrial cancer is to remove one or more groups of lymph nodes (lymph node dissection). Lymph nodes are small, bean-shaped organs located within the body throughout the lymphatic system (the tissues and organs involved in immunity, which aids in the fight against infection and cancer). The purpose of this study is to compare the safety and ability of Lymphoseek and a Vital Blue Dye (tracing agent) to find lymph nodes that may carry cancer from the tumor through the lymphatic system. Lymphoseek will be injected into the tumor on the day before surgery to remove lymph nodes. Vital Blue Dye will be administered during surgery to trace the cancer as well. The surgeon will remove the lymph nodes as part of routine surgery and will keep track of which lymph nodes are identified by Lymphoseek and Vital Blue Dye. These nodes will be sent to another doctor to view them under a microscope and see if the nodes contain cancer cells. The hypothesis is that Lymphoseek can be used safely and will be at least as effective as blue dye in identifying the lymph nodes that may have cancer cells.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lymphoseek plus Vital Blue Dye | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lymphoseek plus Vital Blue Dye
- description
- Lymphoseek plus Vital Blue Dye: Single dose of 50 µg Lymphoseek radiolabeled with 75 MBq Tc 99m injected pre-operatively followed by next day intra-operative administration of vital blue dye.
- interventionNames
- Drug: Lymphoseek plus Vital Blue Dye
Primary outcomes (1)
- measure
- Adverse Events
- timeFrame
- 0-15 days Postoperatively
- description
- Adverse events experienced by the participants and radiation absorbed dose of injected Lymphoseek.
Secondary outcomes (2)
- measure
- Number of Lymphoseek positive lymph nodes detected preoperatively and intraoperatively.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization. 2. The patient has diagnosed cancer of the endometrium. 3. The patient is a candidate for surgical intervention, with lymph node dissection being a part of the surgical plan. 4. The patient is at least 18 years of age at the time of consent. 5. The patient has an Eastern Cooperative Group (ECOG) performance status of Grade 0 - 2. 6. The patient has a clinical negative node status at the time of study entry (i.e., Tis-4, N0, M0). 7. If of childbearing potential, the patient has a negative pregnancy test within 72 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year. Exclusion Criteria: 1. The patient is pregnant or lactating. 2. The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes (i.e., all patients should be any T, N0, M0). 3. The patient has a known hypersensitivity to Lymphazurin or Lymphoseek. 4. The patient has participated in another investigational drug study within 30 days of scheduled surgery.
References
Publications (0)
Data not yet available