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

NCT02975739 | Terminated DMC

• 1 other identifier: NL54535.041.15
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Radioisotopes; Head and Neck Neoplasms

Keywords

Intratumoral; Tongue; Microspheres

Outcome Measures

Primary Outcomes (1)

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

  upto 5 minutes after administration

Secondary Outcomes (4)

• 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

  upto 30 minutes after administration

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

  1-2 hours after administration

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

  3 hours after administration

Study Arms (1)

Holmium-166 microspheres

EXPERIMENTAL

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

Interventions

Holmium-166 (poly L lactic acid) microspheres DEVICE

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

Also known as: Holmium microspheres

Holmium-166 microspheres

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 11720043 BACKGROUND

• 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.

  PMID: 22999975 BACKGROUND

• 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.

  PMID: 22920685 BACKGROUND

• 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.

  PMID: 22068276 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Microspheres

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Marnix G Lam, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Nuclear medicine

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 29, 2016
• Study Start: September 1, 2016
• Primary Completion: September 5, 2018
• Study Completion: September 5, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

NL (1)