To measure changes in lymph nodes on 3D CUBE imaging during (chemo)radiotherapy of head and neck squamous cell carcinoma. By using serial imaging during treatment with a relatively short scan time, we want to establish a biological model of changes…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
oncologie in hoofd/halsgebied
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Lymph nodes will be divided in a benign (< 1cm smallest axis and/or negative
cytology) and a malignant (>1cm smallest axis and/or positive cytology) group.
Volume change (absolute and relative) per lymph node and per patient will be
calculated with a confidence interval of 95%. Treatment response is defined as
a decrease in volume > 50%. Predictive value of volume decrease during
(chemo)radiotherapy is defined as sensitivity, specificity, positive and
negative predictive value of volume change. A ROC curve will be constructed on
the basis of volume decrease between baseline and two weeks. By defining an
optimal area under the curve (AUC) the optimal cut-off value of volume decrease
for prediction of treatment response can be estimated.
Secondary outcome
nvt
Background summary
Imaging studies in squamous cell carcinoma and accompanied lymph node
metastasis have so far focussed mainly on 2D-imaging techniques. E.g. a
disadvantage is the thickness of the slices in de CT imaging, using mostly 5 mm
slice thickness.[18] Therefore it is possible that measured sizes are an
approach of the true size, as lymph nodes commonly vary between 3 and 10 mm in
size.
3D imaging has certain advantages over 2D-imaging. When a scan is performed
with isotropic voxels, it is possible to reconstruct images in all desired
arbitrary planes.[23] Therefore the smallest and biggest axial diameter can be
measured adequately and the volume can be determined more accurately.
Most studies were small and show heterogeneous results. Most studies have used
CT. Although CT provides a good contrast between air, fat and bone, the
contrast between tumor and non-tumor is difficult to visualise. MRI imaging has
excellent soft tissue delineation and is therefore more suitable for tumor and
lymph node imaging. [20]
Current MRI with 3D-FSE CUBE sequence provides isotropic voxels. Slices in
3D-FSE CUBE are smaller in comparison with conventional 2D imaging. Partial
volume artefacts could be reduced.[24] In 3D-sequence the signal-to-noise-ratio
is better compared with 2D-imaging[25] and could provide better visualisation
of anatomical structures.[25, 26]
We expect that with this technique information about the location, size and
shape of the lymph nodes in head and neck can be generated with a relative
short imaging time.
With this technique we want to analyse the response of lymph nodes during
chemoradiotherapy, more particular to analyse whether volume decrease is
gradual over time.
Why is it important to assess the tumor and lymph node response during
treatment?
When volume change has been assessed, a biological model that predicts response
to treatment on the basis of early volume change can be realized. The best
time-point during chemoradiotherapy in which to evaluate the treatment effect
with imaging can be assessed.
This model allows for the possibility to predict response to therapy in an
early time frame in the future. When response to therapy can be evaluated,
treatment can be adjusted early in the course of treatment. Using this
biological model, further possibilities of the optimal time-frame to adapt the
dosage in adaptive radiotherapy can be explored.
Study objective
To measure changes in lymph nodes on 3D CUBE imaging during (chemo)radiotherapy
of head and neck squamous cell carcinoma. By using serial imaging during
treatment with a relatively short scan time, we want to establish a biological
model of changes in lymph nodes during radiotherapy.
Study design
This study will be a single center diagnostic study. The duration of the study
will be 8 months, with an inclusion rate of 1 patient per 2 weeks.
Study burden and risks
Subjects in this study will not be at risk due to the MRI examination. The only
burden that they will have is that they undergo an additional 3D-CUBE MRI in
addition to the standard Baseline MRI, which takes a maximum additional
scanning time of approximately 6 minutes. In the 6 weeks of radiotherapy the
patient is asked to be scanned in the MRI scanner another three times at week
2, 4 and 6 weeks during radiotherapy treatment.
's Gravendijkwal 230
rotterdam 3015 CE
NL
's Gravendijkwal 230
rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- Patients with untreated primary squamous cell carcinomas of pharynx, the oral cavity, and larynx with proven metastases in cervical lymph nodes.
- Scheduled for (chemo)radiotherapy with curative intention.
- Signed informed consent.
Exclusion criteria
carcinoma.
-Patients undergoing any other treatment option like surgery for lymph node metastasis.
-Patients with other types of head and neck malignancies: lymphatic neoplasms, esophageal malignancies, thyroid cancer, lip cancer, skin cancers and other malignancies not originating from the pharynx, laryngeal or oral cavity epithelial origin.
-Having any physical or mental status that interferes with the informed consent procedure.
-Contraindications for MRI (e.g. claustrophobia, arterial clips in central nervous system)
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 | NL40941.078.12 |