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

UMC Utrecht

Status: Terminated

Conditions: Radioisotopes; Head and Neck Neoplasms

Treatments: Device: Holmium-166 (poly L lactic acid) microspheres

Study type: Interventional

Funder types: Other

Identifiers

NCT02975739

NL54535.041.15

Details and patient eligibility

About

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

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Holmium-166 microspheres

Experimental group

Description:

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.

Treatment:

Device: Holmium-166 (poly L lactic acid) microspheres