The accuracy of the different imaging modalities will be assessed with histopathology as the reference. Further, histopathology will be used to estimate the microscopic extension of the tumour in the surrounding tissue. The topological…
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 the different image modalities to measure the tumour volume and
outline as determined by comparison with histopathology as reference standard.
Secondary outcome
· assessment of microscopic invasion of the tumour in the surrounding tissue by
histopathology.
· determination of the interobserver variation for tumour delineation using the
different image modalities.
· feasibility of diffusion weighted imaging for laryngeal and hypopharyngeal
cancer.
· development of a clinical imaging protocol for gross tumour volume (GTV) and
clinical tumour volume (CTV) delineation.
Background summary
Irradiation of the larynx and the hypopharynx using modern fractionation
schedules leads to favourable cure rates at the expense of a relatively large
number of severe (15%) and mild complications (40%). Currently, radiation
treatment of the larynx consists of high dose irradiation of the complete
larynx without delineation of the tumour volume. This is caused by the lack of
information on the extent of the tumour. The hypothesis of the study is that
the tumour volume can be determined by a combination of MRI, DCE-CT and FDG-PET
and that smaller target volumes will be delineated if a combination of these
image modalities is used. Reduction of the target volume for radiation therapy
will reduce the number and decrease the severity of complications.
Study objective
The accuracy of the different imaging modalities will be assessed with
histopathology as the reference. Further, histopathology will be used to
estimate the microscopic extension of the tumour in the surrounding tissue. The
topological correspondence is defined as the conformity index: 2*
volume_overlap_region/(volume_regio1 + volume_regio2)
Study design
This study is a descriptive, diagnostic study, that will evaluate DCE-CT,
FDG-PET and MRI for tumour delineation in laryngeal and hypopharyngeal cancer.
To account for interobserver variations, the tumour volume will be delineated
independently by two observers in all the image modalities. The overlap between
the delineated GTVs of both observers as calculated for the different image
modalities will be presented as a conformity index. Further, the interobserver
overlap will also be described as a conformity index.
Study burden and risks
Apart from the normal clinical imaging procedure, all patients will undergo a
DCE-CT with a higher dose than the normal multi slice CT. Moreover, all imaging
procedures will be performed in a mask before the total laryngectomy, which may
be burdensome for the patient. This enables the use of the presurgery images to
define the target volume in the routinely performed postsurgery radiotherapy,
that might improve target volume definition and minimize radiation dose to
normal structures. In the days before surgery, patients are hospitalized and,
therefore, generally no extra visits to the hospital will be required. Because
of the extensive histopathological procedure, the pathological diagnosis will
be available several days later than normally. This will not delay the adjuvant
radiotherapy treatment of the patient.
postbus 85500
3508GA Utrecht
NL
postbus 85500
3508GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
Patients of the above population scheduled for total laryngectomy.
Informed consent
Exclusion criteria
Patients with indications for primary radiotherapy.
Patients with contraindications for surgery.
Patients who meet exclusion criteria for MRI at 1.5 T 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.
no informed consent.
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 | NL24342.041.09 |