TerminatedPhase 3

Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma

Stopped: The trial was terminated early based on an interim review by the Data and Safety Monitoring Committee for positive efficacy outcome and no safety concerns.

United States101 participantsStarted 2009-05

Plain-language summary

The purpose of this study is to determine the false negative rate (FNR) associated with Lymphoseek-identified sentinel lymph nodes (SLNs) relative to the pathological status of non-sentinel lymph nodes in elective neck dissection (END) in head \& neck squamous cell carcinoma (HNSCC). NEO3-06 (this study) is a Phase 3 clinical trial designed to supplement NEO3-05, a completed Phase 3 clinical trial conducted in patients with breast cancer or melanoma. NEO3-05 was designed to establish Lymphoseek as an effective radio-diagnostic agent to be used in the intraoperative localization of lymph tissue (nodes) in the lymphatic pathway draining the primary site of a tumor.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study.
✓. The patient has a diagnosis of primary squamous cell carcinoma of the head and neck either cutaneous or intra-oral that is anatomically located in: mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone), floor of the mouth, hard palette or oral (mobile) tongue, stage T1-T4a, N0, M0.
✓. Clinical nodal staging (N0) has been confirmed by negative results from contrast CT scan or gadolinium-enhanced MRI or lateral and central neck ultrasound. PET scan cannot be used for this evaluation.
✓. Imaging of the regional nodal basin has been performed within 30 days of the planned lymphadenectomy.
✓. The patient is a candidate for surgical intervention, with intraoperative lymphatic mapping and END included in the surgical plan.
✓. Patients with prior malignancy are allowed provided the patient meets the following criteria:
✓. The patient is at least 18 years of age at the time of consent.
✓. The patient has an Eastern Cooperative Oncology Group (ECOG) status of Grade 0 - 2.

What they're measuring

False Negative Rate (FNR)

Timeframe: Surgery after injection of Lymphoseek

Trial details

NCT IDNCT00911326

SponsorNavidea Biopharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-08

Results submitted2014-07-08

View on ClinicalTrials.gov More Head and Neck Squamous Cell Carcinoma (HNSCC) trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study.
✓. The patient has a diagnosis of primary squamous cell carcinoma of the head and neck either cutaneous or intra-oral that is anatomically located in: mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone), floor of the mouth, hard palette or oral (mobile) tongue, stage T1-T4a, N0, M0.
✓. Clinical nodal staging (N0) has been confirmed by negative results from contrast CT scan or gadolinium-enhanced MRI or lateral and central neck ultrasound. PET scan cannot be used for this evaluation.
✓. Imaging of the regional nodal basin has been performed within 30 days of the planned lymphadenectomy.
✓. The patient is a candidate for surgical intervention, with intraoperative lymphatic mapping and END included in the surgical plan.
✓. Patients with prior malignancy are allowed provided the patient meets the following criteria:
✓. The patient is at least 18 years of age at the time of consent.
✓. The patient has an Eastern Cooperative Oncology Group (ECOG) status of Grade 0 - 2.

Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria