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

Not Applicable

Terminated

• Conditions: Radioisotopes; Head and Neck Neoplasms
• Interventions: Device: Holmium-166 (poly L lactic acid) microspheres

• Registration Number: NCT02975739
• Lead Sponsor: UMC Utrecht

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-29
• Status Verified: 2018-09
• Primary Completion: 2018-09-05
• Study Completion: 2018-09-05
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Holmium-166 microspheres	Holmium-166 (poly L lactic acid) microspheres	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.

Primary Outcome Measures

Name	Time	Method
Total amount of activity leakage (in percentage) in the oral cavity rinsing fluid.	upto 5 minutes after administration

Secondary Outcome Measures

Name	Time	Method
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	3 hours after administration	Radioactivity in blood and urine sample

Trial Locations

Locations (1)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands