Mapping lymph drainage to customize radiation for head and neck cancer
Mapping of Sentinel Lymph Node Drainage Using SPECT/CT to Tailor Highly Selective Elective Nodal Irradiation in Node-negative Neck of Patients with Head and Neck Cancer
NA · The Netherlands Cancer Institute · NCT03968679
This study is testing a new way to use imaging to customize radiation treatment for people with head and neck cancer to help reduce side effects and protect healthy tissue.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Netherlands Cancer Institute (other) |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT03968679 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of lymph drainage mapping (LDM) to tailor elective nodal irradiation (ENI) specifically to the affected side of the neck in patients with head and neck cancer. By using SPECT/CT imaging, the study aims to identify whether there is lymph drainage to the contralateral neck and only administer radiation if necessary. The approach seeks to minimize radiation exposure to healthy tissues and reduce associated toxicities such as mucositis and dysphagia. The study expands on previous findings to further refine treatment protocols and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with newly diagnosed, histopathologically confirmed primary head and neck squamous cell carcinoma (HNSCC) that does not cross the midline.
Not a fit: Patients with distant metastatic spread, previous radiation treatment, or recurrent tumors in the head and neck region may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced radiation exposure and fewer side effects for patients with head and neck cancer.
How similar studies have performed: Previous studies using lymph drainage mapping have shown promising results in reducing unnecessary radiation exposure, indicating a potential for success in this modified approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnosed and histopathologically proven primary HNSCC * T1-4N0-2b * Tumor does not cross midline * WHO performance status 0 or 1 * Signed written informed consent Exclusion Criteria: * Distant metastatic spread at the time of inclusion * Chemotherapy or surgery (for the present tumor), prior to inclusion * Previous radiation treatment in the head and neck region, for any reason * Previous neck dissection * Recurrent or second primary tumor in the head and neck region * Head and neck malignancies arising from skin, lip, nose, sinuses, nasopharynx, salivary glands, thyroid gland or esophagus * Pregnancy or no active contraception for pre-menopausal women * Known hypersensitivity to iodine or nanocolloid injection * Having any condition (physical, mental, sociological) that interferes with the informed consent procedure and follow-up schedules
Where this trial is running
Amsterdam
- Netherlands Cancer Institute — Amsterdam, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Abrahim Al-Mamgani, MD, PhD — The Netherlands Cancer Institute
- Study coordinator: Abrahim Al-Mamgani, MD, PhD
- Email: a.almamgani@nki.nl
- Phone: +31205129111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head and Neck Cancer, head and neck cancer, lymph drainage mapping, sentinel node procedure, radiotherapy, unilateral elective neck irradiation