Clinical trial · Interventional
Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Cancer Patients
Prospective Study to Assess the Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Patients With Carcinoma of the Upper Aerodigestive Tract
- 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)
Hypothesis 1. The submandibular gland is not a lymphatic organ and usually remains uninvolved with head and neck cancer despite the presence of metastatic disease in the lymph nodes that surround it. 2. All the lymph nodes in the submandibular triangle can be removed without resection of the submandibular gland. Study Design A better understanding of the frequency of submandibular gland involvement may lead to refined treatment strategies for head and neck cancer, which can possibly spare removal of the submandibular gland and potentially improve the long term side effects from therapy.
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 |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neck dissection of at least the ipsilateral sub-level 1B | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients
- interventionNames
- Procedure: neck dissection of at least the ipsilateral sub-level 1B
Primary outcomes (1)
- measure
- the Number of Lymph Nodes: 1. Identified Within Each Lymph Node Group, 2.Located Within the Submandibular Gland, and 3. Within the Fibrofatty Contents Lying Deep to the Submandibular Gland.
- timeFrame
- Post Surgical Time point
- description
- The number of head/ neck lymph nodes in pre-defined groups: Preglandular, Prevascular, Retrovascular, and Retroglandular as well as the number of nodes within the submandibular gland and within the fibrofatty contents lying deep to the submandibular gland.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically or cytologically confirmed carcinoma of the oral cavity, oropharynx, larynx or hypopharynx * Treatment of the regional lymph nodes to include neck dissection performed as the primary modality * No previous treatment to the neck * No previous treatment for the index cancer (surgery, chemotherapy, radiation or biological therapy) * No known distant metastatic disease * Age \>/= 18 * The ability to understand and willingness to sign a study-specific written informed consent form * Protocol treatment must begin \</= 8 weeks of diagnostic biopsy Exclusion Criteria: * Previous or concurrent head and neck primaries * Prior surgery to study site other than biopsy * Patients receiving any other treatment for cancer within 30 days previously * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements * Known allergy to Lymphazurin® * Pregnant or breast feeding females
References
Publications (1)
- BACKGROUNDRobbins KT, Clayman G, Levine PA, Medina J, Sessions R, Shaha A, Som P, Wolf GT; American Head and Neck Society; American Academy of Otolaryngology--Head and Neck Surgery. Neck dissection classification update: revisions proposed by the American Head and Neck Society and the American Academy of Otolaryngology-Head and Neck Surgery. Arch Otolaryngol Head Neck Surg. 2002 Jul;128(7):751-8. doi: 10.1001/archotol.128.7.751. No abstract available. PMID 12117328