RadioisotopesHITNCT02975739
Feasibility of Holmium-166 Micro Brachytherapy in Head and Neck Tumors
A study testing Holmium-166 (poly L lactic acid) microspheres in people with Radioisotopes and Head and Neck Neoplasms, run by UMC Utrecht at 1 site in Netherlands.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radioisotopes, Head and Neck Neoplasms
- What is being tested?
- Holmium-166 (poly L lactic acid) microspheres
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2016to 5 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Radioisotopes, Head and Neck Neoplasms
- Being tested
- Holmium-166 (poly L lactic acid) microspheres
- Keywords
- Intratumoral, Tongue, Microspheres
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium-166 (poly L lactic acid) microspheresDevice
Also called Holmium microspheres
Intratumoral injections of Holmium-166 (poly L lactic acid) microspheres
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Holmium-166 (poly L lactic acid) microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of activity leakage (in percentage) in the oral cavity rinsing fluid.
Measured: upto 5 minutes after administration
Secondary outcomes (4)
Occurrence of (serious) adverse events
Measured: Between administration and resection of the tumor (max 12 days)
The biodistribution of Holmium-166 microspheres after intra-tumoural injection
SPECT Thorax and Abdomen Radioactivity in a blood and urine sample
Measured: upto 30 minutes after administration
The biodistribution of Holmium-166 microspheres after intra-tumoural injection
MRI
Measured: 1-2 hours after administration
The biodistribution of Holmium-166 microspheres after intra-tumoural injection
Radioactivity in blood and urine sample
Measured: 3 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startSep 2016
- Primary completion5 Sep 2018
- Study completion5 Sep 2018
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for RadioisotopesStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marnix Lam, UMC Utrecht
- Investigators
- Marnix G Lam, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975739
- Sponsor's protocol ID
- NL54535.041.15
- Acronym
- HIT
- Status last verified
- Sep 2018
- First submitted
- 15 Nov 2016
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 11720043Bult 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.
PubMed 22999975Smits 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.
PubMed 22920685Bult 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.
PubMed 22068276
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02975739
- Acronym / sponsor ID
- HIT / NL54535.041.15
- Conditions
- Radioisotopes, Head and Neck Neoplasms
- Keywords
- Intratumoral, Tongue, Microspheres
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Holmium-166 microspheres | Experimental | Device: Holmium-166 (poly L lactic acid) microspheresSingle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holmium-166 (poly L lactic acid) microspheresAlso: Holmium microspheresIntratumoral injections of Holmium-166 (poly L lactic acid) microspheres | Device | Holmium-166 microspheres |
Primary outcome
Total amount of activity leakage (in percentage) in the oral cavity rinsing fluid.
Time frame: upto 5 minutes after administration
4 secondary outcomes
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
The biodistribution of Holmium-166 microspheres after intra-tumoural injection
Time frame: 1-2 hours after administration
The biodistribution of Holmium-166 microspheres after intra-tumoural injection
Time frame: 3 hours after administration
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Background: PubMed 11720043van 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.
- Background: PubMed 22999975Bult 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.
- Background: PubMed 22920685Smits 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.
- Background: PubMed 22068276Bult 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marnix G Lam, MD, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holmium-166 (poly L lactic acid) microspheres in people with Radioisotopes and Head and Neck Neoplasms, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of activity leakage (in percentage) in the oral cavity rinsing fluid. (time frame: upto 5 minutes after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02975739, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.