The main objective is to establish the feasibility of 166Ho-microspheres for intra-tumoural injections in OSCC by defining the total amount of leakage. The secondary objectives are to assess the safety profile by recording the adverse events, and…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Patients with an early stage (T1-2) oral squamous cell carcinoma (OSCC) < 4 cm
receive local surgery. Morbidity and functional loss may be significant. Local
treatment by intra-tumoural injection of radioactive 166Ho-microspheres may
result in effective treatment for downscaling of the tumour. Subsequently
limited surgical resection associated with less morbidity could be a
possibility. The feasibility, biodistribution, safety and efficacy of this
approach will be tested in this clinical study.
Study objective
The main objective is to establish the feasibility of 166Ho-microspheres for
intra-tumoural injections in OSCC by defining the total amount of leakage. The
secondary objectives are to assess the safety profile by recording the adverse
events, and radioactivity and holmium content in a blood and a urine sample
after administration. In addition, the biodistribution of 166Ho -microspheres
in the tumour after intra-tumoural injection will be studied ex-vivo with micro
CT and histology.
Study design
Observational with invasive measurements, first-in-man, non-randomized, open
label, non-comparative, proof of concept study.
Intervention
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 week before the planned surgery in a
*treat-and-resect* protocol.
Study burden and risks
The burden and risk associated with participation in this study is expected to
be moderate due to;
* The injected activity will be a factor >200 less compared to the HEPAR study
on hepatic radioembolization (30 MBq versus approximately 6000 MBq).
* The risk of radionecrosis to healthy neighbouring tissue is minimal because
90% of the dose will be absorbed within 3.2 mm.
* No severe adverse events were observed in >40 animal patients with more
challenging anatomy, treated with much higher activities (factor 10).
* Incorrect administration will be avoided in clearly visible and palpable
tumours of the oral cavity.
* Even after complete leakage in the gastrointestinal system or in the case of
IV injection no theoretical risk exists on serious adverse events.
During an outpatient visit, the patients will receive a radioactive
166Ho-microspheres suspension, injected in the tumour under local anaesthesia.
Furthermore, MR and SPECT/CT imaging will be performed after administration,
and a blood and urine sample will be collected before discharge.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54535.041.15 |