Head and Neck Neoplasms, Radioisotopes
Conditions
Keywords
Intratumoral, Tongue, Microspheres
Brief summary
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
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.
Interventions
DEVICEHolmium-166 (poly L lactic acid) microspheres
Intratumoral injections of Holmium-166 (poly L lactic acid) microspheres
Sponsors
UMC Utrecht
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total amount of activity leakage (in percentage) in the oral cavity rinsing fluid. | upto 5 minutes after administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | upto 30 minutes after administration | SPECT Thorax and Abdomen Radioactivity in a blood and urine sample |
Countries
Netherlands
Outcome results
None listed