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

Primary Purpose

Radioisotopes, Head and Neck Neoplasms

Status

Terminated

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Holmium-166 (poly L lactic acid) microspheres

About this trial

This is an interventional treatment trial for Radioisotopes focused on measuring Intratumoral, Tongue, Microspheres

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must have given written informed consent.
Aged 18 years and over.
Confirmed histological diagnosis of squamous cell carcinoma of the tongue.
primary tumor, regional nodes, metastasis (TNM) stage T1-2 Nx M0.
Eligible for local surgery with curative intent.
World Health Organization (WHO) Performance status 0-2.

Exclusion Criteria:

Previous oncologic surgery and/or external beam radiation therapy on the tongue and oral floor.
Major surgery (Oro-facial) within the past 4 weeks or incompletely healed surgical incisions before starting study therapy.
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.
Pregnancy or nursing (women of child-bearing potential).
Patients suffering from psychic disorders that make a comprehensive judgment impossible, such as psychosis, hallucinations and/or depression.
Previous enrolment in the present study.

Sites / Locations

University Medical Center Utrecht

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Holmium-166 microspheres

Arm 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.

Outcomes

Primary Outcome Measures

Total amount of activity leakage (in percentage) in the oral cavity rinsing fluid.

Secondary Outcome Measures

Occurrence of (serious) adverse events

The biodistribution of Holmium-166 microspheres after intra-tumoural injection

SPECT Thorax and Abdomen Radioactivity in a blood and urine sample

The biodistribution of Holmium-166 microspheres after intra-tumoural injection

MRI

The biodistribution of Holmium-166 microspheres after intra-tumoural injection

Radioactivity in blood and urine sample

Full Information

NCT ID

NCT02975739

First Posted

November 15, 2016

Last Updated

September 5, 2018

Sponsor

UMC Utrecht

1. Study Identification

Unique Protocol Identification Number

NCT02975739

Brief Title

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

Acronym

HIT

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Terminated

Why Stopped

Slow accrual

Study Start Date

September 2016 (undefined)

Primary Completion Date

September 5, 2018 (Actual)

Study Completion Date

September 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

UMC Utrecht

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Radioisotopes, Head and Neck Neoplasms

Keywords

Intratumoral, Tongue, Microspheres

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Holmium-166 microspheres

Arm Type

Experimental

Arm 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.

Intervention Type

Device

Intervention Name(s)

Holmium-166 (poly L lactic acid) microspheres

Other Intervention Name(s)

Holmium microspheres

Intervention Description

Intratumoral injections of Holmium-166 (poly L lactic acid) microspheres

Primary Outcome Measure Information:

Title

Total amount of activity leakage (in percentage) in the oral cavity rinsing fluid.

Time Frame

upto 5 minutes after administration

Secondary Outcome Measure Information:

Title

Occurrence of (serious) adverse events

Time Frame

Between administration and resection of the tumor (max 12 days)

Title

The biodistribution of Holmium-166 microspheres after intra-tumoural injection

Description

SPECT Thorax and Abdomen Radioactivity in a blood and urine sample

Time Frame

upto 30 minutes after administration

Title

The biodistribution of Holmium-166 microspheres after intra-tumoural injection

Description

MRI

Time Frame

1-2 hours after administration

Title

The biodistribution of Holmium-166 microspheres after intra-tumoural injection

Description

Radioactivity in blood and urine sample

Time Frame

3 hours after administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must have given written informed consent. Aged 18 years and over. Confirmed histological diagnosis of squamous cell carcinoma of the tongue. primary tumor, regional nodes, metastasis (TNM) stage T1-2 Nx M0. Eligible for local surgery with curative intent. World Health Organization (WHO) Performance status 0-2. Exclusion Criteria: Previous oncologic surgery and/or external beam radiation therapy on the tongue and oral floor. Major surgery (Oro-facial) within the past 4 weeks or incompletely healed surgical incisions before starting study therapy. 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. Pregnancy or nursing (women of child-bearing potential). Patients suffering from psychic disorders that make a comprehensive judgment impossible, such as psychosis, hallucinations and/or depression. Previous enrolment in the present study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marnix G Lam, MD, PhD

Organizational Affiliation

UMC Utrecht

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Medical Center Utrecht

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

11720043

Citation

van Es RJ, Nijsen JF, van het Schip AD, Dullens HF, Slootweg PJ, Koole R. Intra-arterial embolization of head-and-neck cancer with radioactive holmium-166 poly(L-lactic acid) microspheres: an experimental study in rabbits. Int J Oral Maxillofac Surg. 2001 Oct;30(5):407-13. doi: 10.1054/ijom.2001.0129.

Results Reference

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PubMed Identifier

22999975

Citation

Bult W, Vente MA, Vandermeulen E, Gielen I, Seevinck PR, Saunders J, van Het Schip AD, Bakker CJ, Krijger GC, Peremans K, Nijsen JF. Microbrachytherapy using holmium-166 acetylacetonate microspheres: a pilot study in a spontaneous cancer animal model. Brachytherapy. 2013 Mar-Apr;12(2):171-7. doi: 10.1016/j.brachy.2012.08.001. Epub 2012 Sep 19.

Results Reference

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PubMed Identifier

22920685

Citation

Smits ML, Nijsen JF, van den Bosch MA, Lam MG, Vente MA, Mali WP, van Het Schip AD, Zonnenberg BA. Holmium-166 radioembolisation in patients with unresectable, chemorefractory liver metastases (HEPAR trial): a phase 1, dose-escalation study. Lancet Oncol. 2012 Oct;13(10):1025-34. doi: 10.1016/S1470-2045(12)70334-0. Epub 2012 Aug 22. Erratum In: Lancet Oncol. 2012 Nov;13(11):e464.

Results Reference

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PubMed Identifier

22068276

Citation

Bult W, de Leeuw H, Steinebach OM, van der Bom MJ, Wolterbeek HT, Heeren RM, Bakker CJ, van Het Schip AD, Hennink WE, Nijsen JF. Radioactive holmium acetylacetonate microspheres for interstitial microbrachytherapy: an in vitro and in vivo stability study. Pharm Res. 2012 Mar;29(3):827-36. doi: 10.1007/s11095-011-0610-7. Epub 2011 Nov 9.

Results Reference

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

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