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

Head and Neck Neoplasms Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02975739
• Other study ID #: NL54535.041.15
• Status: Terminated
• Phase: N/A
• Start date: September 2016
• Est. completion date: September 5, 2018

Study information

• Verified date: September 2018
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 5, 2018
• Est. primary completion date: September 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Radioisotopes

Intervention

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

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of activity leakage (in percentage) in the oral cavity rinsing fluid.		upto 5 minutes after administration
Secondary	Occurrence of (serious) adverse events		Between administration and resection of the tumor (max 12 days)
Secondary	The biodistribution of Holmium-166 microspheres after intra-tumoural injection	SPECT Thorax and Abdomen Radioactivity in a blood and urine sample	upto 30 minutes after administration
Secondary	The biodistribution of Holmium-166 microspheres after intra-tumoural injection	MRI	1-2 hours after administration
Secondary	The biodistribution of Holmium-166 microspheres after intra-tumoural injection	Radioactivity in blood and urine sample	3 hours after administration