Lymph node and imaging evaluation in oral melanomas
Oral malignant melanoma (OMM) is a highly aggressive oral tumor of dogs. Presence of spread to regional lymph nodes (LN) is a known poor prognostic indicator. Evaluation of LN status is currently performed by histopathologic examination following removal of all surgically identifiable LN in the neck region.
This study aims to identify the sentinel lymph node (SLN), allowing a targeted approach to reduce need for extensive LN resection surgery.
This study will evaluate removed LNs with a new emerging diagnostic tool, optical coherence tomography (OCT), to determine if OCT imaging findings can accurately detect cancer in canine LNs. In the future, OCT may be used for intraoperative assessment of LN status to guide extent of LN removal for individual patients.
What qualifies my pet for enrollment in this in this trial?
To participate in this clinical trial your pet must:
- Weight greater then 5kg (11lbs)
- Have cytologic or histopathologic diagnosis of oral malignant melanoma
- Owners must have intention to pursue surgical removal of the primary tumor and associated neck lymph nodes.
- Be free of significant comorbidities that prevent them from undergoing general anesthesia, a 12 hours preoperative fast, or present significant risk for use of local or intravenous contrast material.
- Not prior malignant tumors on the mouth, head, or neck, or had prior removal of any mandibular, parotid, retropharyngeal, or superficial cervical lymph nodes.
- Patients who have undergone chemotherapy within 6 months prior will be excluded.
What does enrolling my pet in this clinical trial involve?
- Patients will undergo routine preoperative staging consistent with current standard of care (bloodwork, thoracic radiographs).
- All patients enrolled in the study will undergo sedation or general anesthesia for computed tomography (CT) of the head and regional contrast administration for sentinel lymph node (SLN) mapping for surgical planning. Following CT, the SLN identified will be sampled using ultrasound guidance.
- All patients will undergo surgical removal of the primary tumor as well as all surgically identifiable cervical lymph nodes as is current standard of care.
- Patients are required to be evaluated at 10-14 days post operatively for incision evaluation and 3- and 6-months post operatively for routine restaging chest x-rays.
Client Compensation
The study will cover the cost of your dog's surgical planning CT, cervical lymph node removal and cervical lymph node evaluation. The study will also cover the cost of 3 view thoracic radiographs for restaging at 3 and 6 months post-operatively.
The study does not cover the cost of other preoperative work up (primary tumor biopsy/FNA, bloodwork, thoracic radiographs, etc), primary tumor removal, hospitalization, postoperative care, or additional oncologic care (radiation therapy, chemotherapy, melanoma vaccine). Costs associated with adverse events (including but not limited to swelling, lymphedema, and incisional complications) are not covered by the study.
Pre-screening Questionnaire
If you believe your pet may be eligible to enter this study, please fill out a pre-screening questionnaire.