To compare the volume of the tumour as determined using DW-MRI images of laryngeal and hypopharyngeal tumours with that of the actual tumour as determined using histopathology after laryngectomy. Further, histopathology will be used to determine theā¦
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The accuracy of DW-MRI in determining the volume of the tumour.
Secondary outcome
The sensitivity (part of the tumour that is delineated) and positive predictive
power (part of the delineated volume that is tumour) of DW-MRI based tumour
delineation compared with values obtained using CT, PET and anatomical MR
imaging.
The microscopic extension of the tumour measured as the distance between the
gross tumour volume and the most distant microscopic lesions in the
histopathology.
Background summary
Irradiation of the larynx and the hypopharynx using modern radiotherapy
techniques leads to favourable cure rates at the expense of a relatively large
number of severe (15%) and mild complications (40%). These complications are
caused by the irradiation of healthy tissues. The volume of healthy tissue
exposed to a high dose of radiation can be reduced since in imaging validation
studies it has been observed that the tumour volume is overestimated using
current imaging techniques.
The hypothesis of this study is that the tumour volume can be determined
accurately using a newly developed diffusion weighted magnetic resonance
imaging contrast (DW-MRI). Reduction of the target volume for radiation therapy
will reduce the number of complications and decrease the severity of
complications.
Study objective
To compare the volume of the tumour as determined using DW-MRI images of
laryngeal and hypopharyngeal tumours with that of the actual tumour as
determined using histopathology after laryngectomy. Further, histopathology
will be used to determine the exact location, extent and the microscopical
extension of the tumour in the surrounding tissue.
Study design
This study is a descriptive, diagnostic study that will evaluate DW-MRI images
for tumour delineation in laryngeal and hypopharyngeal cancer.
Study burden and risks
In the normal clinical procedure patients will undergo a magnetic resonance
imaging (MRI) scan, a computed tomography (CT) scan with iodine contrast and a
Fluor-18-Fluorodeoxyglucose positron emission tomography (FDG-PET) scan. As
part of standard care, all the imaging procedures before the total laryngectomy
will be performed in a radiotherapy mask.
If standard clinical imaging is not available, too old (>20 days prior to
surgery) or of insufficient quality for study purposes, participants will
undergo an extra FDG-PET/CT and/or MRI. This ensures that all participants
receive FDG-PET/CT and MRI prior to treatment. However, most participants will
receive clinical imaging, therefore, no study burden to the participant due to
imaging is expected. If additional FDG-PET/CT is needed, participants will be
exposed to extra radiation due to study participation.
In the days before surgery patients are hospitalized and consequently no extra
visits to the hospital will generally be required.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- Patients with a T3 or T4 laryngeal or hypopharyngeal cancer scheduled for
total laryngectomy.
- Age >= 18 years.
- Informed consent.
Exclusion criteria
- Patients with indications for primary radiotherapy.
- Patients with contraindications for surgery.
- Patients who meet exclusion criteria for MRI at 3T as defined in the
protocols of the Radiology department.
- Patients with contraindication for CT contrast administration as defined in
the protocols of the Radiology department.
- Patients with insulin dependent diabetes mellitus.
Design
Recruitment
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 | NL53576.041.15 |