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

September 5, 2018 updated by: Marnix Lam, UMC Utrecht

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Holmium-166 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.
Device: Holmium-166 (poly L lactic acid) microspheres
Intratumoral injections of Holmium-166 (poly L lactic acid) microspheres
Other Names:
  • Holmium microspheres

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: Marnix G Lam, MD, PhD, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

September 5, 2018

Study Completion (Actual)

September 5, 2018

Study Registration Dates

First Submitted

November 15, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL54535.041.15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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