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

UMC Utrecht1 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Radioisotopes Head and Neck Neoplasms

Interventions

Holmium-166 (poly L lactic acid) microspheresDEVICE

Intratumoral injections of Holmium-166 (poly L lactic acid) microspheres

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients must have given written informed consent. 2. Aged 18 years and over. 3. Confirmed histological diagnosis of squamous cell carcinoma of the tongue. 4. primary tumor, regional nodes, metastasis (TNM) stage T1-2 Nx M0. 5. Eligible for local surgery with curative intent. 6. World Health Organization (WHO) Performance status 0-2. Exclusion Criteria: 1. Previous oncologic surgery and/or external beam radiation therapy on the tongue and oral floor. 2. Major surgery (Oro-facial) within the past 4 weeks or incompletely healed surgical incisions before starting study therapy. 3. 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. 4. Pregnancy or nursing (women of child-bearing potential). 5. Patients suffering from psychic disorders that make a comprehensive judgment impossible, such as psychosis, hallucinations and/or depression. 6. Previous enrolment in the present study.

Locations (1)

University Medical Center Utrecht

Utrecht, Netherlands

Outcomes

Primary Outcomes

Total amount of activity leakage (in percentage) in the oral cavity rinsing fluid.

Time frame: upto 5 minutes after administration

Secondary Outcomes

Occurrence of (serious) adverse events

Time frame: 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

Time frame: upto 30 minutes after administration

The biodistribution of Holmium-166 microspheres after intra-tumoural injection

MRI

Time frame: 1-2 hours after administration

The biodistribution of Holmium-166 microspheres after intra-tumoural injection

Radioactivity in blood and urine sample

Time frame: 3 hours after administration

Data from ClinicalTrials.gov

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