We would like to develop a method for preparation and preservation of the neck dissection specimen in order to facilitate reliable co-registration with the nano-MR images of the neck.
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity and specificity of the USPIO-enhanced MRI detecting (subclinical)
lymph node metastases in head-and-neck cancer.
Secondary outcome
Development of a scoring system providing criteria for the radiological
assessment of USPIO-enhanced MR images regarding the assessment of cervical
lymph nodes.
Background summary
The presence of lymph node metastases has a large impact on prognosis and
treatment in head*and neck cancer patients and necessitates treatment
intensification. High*resolution imaging techniques such as ultrasound, MRI*
and CT*scanning and ultrasound*guided fine needle aspiration (FNA), have
resulted in an increasingly improved detection rate of lymph node metastasis.
However, despite increased resolution, up to 20% of patients with a pre*
operative clinically negative neck will have occult metastases in the neck
dissection specimen anno 2017. New, non*invasive techniques are needed to
improve the detection of small lymph node metastases. One promising new
technique is nano*MRI, an MR*imaging technique in which ultrasmall
superparamagnetic iron oxide (USPIO) particles are intravenously infused as a
contrast agent in patients 24*36 hours before the MRI examination and has
proven to be of value in detecting lymph node metastases. Results on diagnostic
accuracy of nano*MRI in head*and*neck cancer are sparse, but promising, with
reported sensitivity ranging from 80% to 95% and the specificity from 81 to
100%. Most of these were performed over 10 years ago with older techniques and
were small in cohort size. We want to validate this technique in our large
population of head*and*neck cancer patients and directly translate our findings
into clinical practice.
Study objective
We would like to develop a method for preparation and preservation of the neck
dissection specimen in order to facilitate reliable co-registration with the
nano-MR images of the neck.
Study design
Observational study
Study burden and risks
Except for the discomfort of lying in a MRI scanner for about 30-45 minutes,
MRI offers no risks for patients without pre-assessed contra-indications. The
USPIO contrast agent can cause a contrast reaction during and shortly after
administration. Therefore this administration is performed within the hospital
under supervision of qualified personnel. Surgical interventions are performed
if indicated by the hospital*s current guidelines.
Geert Grooteplein Zuid 32
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 32
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
- Males and females aged >18 years.
- Patients with histopathologically proven cT0-4N0-2M0 squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or unknown primary.
- Patients planned for a neck dissection.
- Patients providing informed consent
Exclusion criteria
- Patients who underwent radio- and/or chemotherapy to the neck before surgery.
- Patients who had a previous lymphadenectomy in the head and neck region.
- Patients who are pregnant and/or breast-feeding.;Patients with contraindications to MRI:
- Epilepsy
- Metallic implants ;Patients with contraindications to ferumoxtran-10:
- prior allergic reaction to ferumoxtran-10 or any other iron preparation
- prior allergic reaction contributed to dextran or other polysaccharide, in any preparation
- prior allergic reaction to contrast media of any type
- hereditary hemochromatosis, thalassemia, sickle cell anemia
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 |
|---|---|
| EudraCT | EUCTR2018-002168-14-NL |
| CCMO | NL66248.091.18 |