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

This study is currently recruiting participants.
Verified November 2016 by Marnix Lam, UMC Utrecht
Sponsor:
ClinicalTrials.gov Identifier:
NCT02975739
First Posted: November 29, 2016
Last Update Posted: November 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Marnix Lam, UMC Utrecht
  Purpose

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


Condition Intervention Phase
Radioisotopes Head and Neck Neoplasms Device: Holmium-166 (poly L lactic acid) microspheres Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Marnix Lam, UMC Utrecht:

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

Secondary Outcome Measures:
  • 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 [ Time Frame: upto 30 minutes after administration ]
    SPECT Thorax and Abdomen Radioactivity in a blood and urine sample

  • The biodistribution of Holmium-166 microspheres after intra-tumoural injection [ Time Frame: 1-2 hours after administration ]
    MRI

  • The biodistribution of Holmium-166 microspheres after intra-tumoural injection [ Time Frame: 3 hours after administration ]
    Radioactivity in blood and urine sample


Estimated Enrollment: 10
Study Start Date: September 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Holmium microspheres

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975739


Locations
Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Robbert C Bakker, MD, MsC       r.c.bakker@umcutrecht.nl   
Principal Investigator: Marnix G Lam, MD, PhD         
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Marnix G Lam, MD, PhD UMC Utrecht
  More Information

Publications:
Responsible Party: Marnix Lam, Professor Nuclear medicine, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02975739     History of Changes
Other Study ID Numbers: NL54535.041.15
First Submitted: November 15, 2016
First Posted: November 29, 2016
Last Update Posted: November 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Marnix Lam, UMC Utrecht:
Intratumoral
Tongue
Microspheres

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms