Feasibility of holmium-166 microspheres for selective intra-tumoural treatment in head and neck cancer: biodistribution and safety in patients with malignancy of the oral cavity (the HIT study)

Feasibility of holmium-166 microspheres for selective intra-tumoural treatment in head and neck cancer: biodistribution and safety in patients with malignancy of the oral cavity (the HIT study) - HIT study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45143

Enrollment

Registered

2015-11-17

Start date

2016-08-31

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

squamous cell carcinoma of the oral cavity

Interventions

166Ho-microspheres will be injected in the tumour under ultrasound guidance using a needle and syringe with microsphere suspension. This intervention will be performed under local anaesthesia one we

Eligibility

Age

18 Years to 99 Years

Inclusion 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 oral cavity. 4. TNM-stage T1-2 Nx M0. 5. Eigible for local surgery with curative intent. 6. World Health Organization (WHO) Performance status 0-2.

Exclusion criteria

Exclusion criteria: 1. Previous oncologic surgery and/or external beam radiation therapy on the tongue and oral floor. 2. Major surgery (oral cavity) 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.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the total amount of activity in the tumor (in percentage). We consider a leakage of * of the injected activity from the tumor the maximum acceptable leakage. Therefore we consider this treatment feasible, if the detected activity in the tumor is more than two third of the injected activity.	—

Secondary

Measure	Time frame
Secondary endpoints include adverse events occurring between the time of administration until resolution of the adverse events, and determination of radioactivity and holmium content in a blood and urine sample after administration. Furthermore, the biodistribution of 166Ho-microspheres after intra-tumoural injection will be studied ex-vivo with micro CT and histology.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)