Feasibility of Holmium-166 Micro Brachytherapy in Head and Neck Tumors

Study Overview
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Brief Summary
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The main objective is to establish the feasibility of 166-Holmium microspheres for intratumoral injections in oral squamous cell carcinoma (OSCC) of the tongue. Participants will receive intratumoral injections with a low radioactive 166-Holmium microspheres followed by surgical resection

Detailed Description
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166-Holmium microspheres poly lactic acid microspheres are currently used in selective internal radiation therapy. These microspheres emits beta radiation. The majority of the radiation dose will be absorbed within 3.2 mm with a maximum penetration in tissue of 9 mm. Therefore this can result in a high local tumor ablative dose with minimal dose to healthy adjacent tissue.

Official Title
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Feasibility of Holmium-166 Microspheres for Selective Intra-tumoural Treatment in Head and Neck Cancer: Biodistribution and Safety in Patients With Malignancy of the Tongue

Conditions
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Radioisotopes, Head and Neck Neoplasms

Intervention / Treatment
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* Device: Holmium-166 (poly L lactic acid) microspheres


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have given written informed consent. Aged 18 years and over. Confirmed histological diagnosis of squamous cell carcinoma of the tongue. primary tumor, regional nodes, metastasis (TNM) stage T1-2 Nx M0. Eligible for local surgery with curative intent. World Health Organization (WHO) Performance status 0-2. Exclusion Criteria: Previous oncologic surgery and/or external beam radiation therapy on the tongue and oral floor. Major surgery (Oro-facial) within the past 4 weeks or incompletely healed surgical incisions before starting study therapy. Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 4.03) grade 2 from previous anti-cancer therapy. Pregnancy or nursing (women of child-bearing potential). Patients suffering from psychic disorders that make a comprehensive judgment impossible, such as psychosis, hallucinations and/or depression. Previous enrolment in the present study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Holmium-166 microspheres<br>Single session of 4 intratumoral injections consisting of 0.1-0.3 ml radioactive Holmium-166 microsphere suspension with a total activity 30 Megabecquerel, 7-12 days prior to surgical resection. | Device: Holmium-166 (poly L lactic acid) microspheres<br>* Intratumoral injections of Holmium-166 (poly L lactic acid) microspheres<br>* Other names: Holmium microspheres;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of activity leakage (in percentage) in the oral cavity rinsing fluid. |  | upto 5 minutes after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of (serious) adverse events |  | Between administration and resection of the tumor (max 12 days) | 
| The biodistribution of Holmium-166 microspheres after intra-tumoural injection | SPECT Thorax and Abdomen Radioactivity in a blood and urine sample | upto 30 minutes after administration | 
| The biodistribution of Holmium-166 microspheres after intra-tumoural injection | MRI | 1-2 hours after administration | 
| The biodistribution of Holmium-166 microspheres after intra-tumoural injection | Radioactivity in blood and urine sample | 3 hours after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intratumoral, Tongue, Microspheres