Primary objective: - Optimization of MR diffusion quality in head and neck squamous cell carcinoma by an extension of the scan protocol and a pillow filled with pineapple juice. Secundary objective:- To determine the most optimal amount and…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality Diffusion-weighted images
Diffusion parameters (ADC), IVIM-parameters (D, D*, f)
Reproducibility IVIM parameters
Secondary outcome
Optimale aantal en distributie van b-waardencombinatie
Background summary
Nowadays more imaging techniques are used for diagnostic purposes,
treatmentplanning, non-invasive treatment monitoring of (chemo)radiotherapy or
for outcome prediction. Continuous optimization of this imaging is necessary to
optimize the sensitivity and specificity for both diagnosis and prognosis.
On one hand, conventional MRI images are specifically directed to the anatomy
of (tumor) tissue. On the other hand, perfusion MRI (contrast enhancement) and
diffusion MRI can map physiology in tissue, which can be of value in
determining precise staging and predictive response response rate. In addition,
there are indications that changes in functional parameters occur faster than
the classic response parameters based on size (diameter or volume change).
Intravoxel incoherent motion (IVIM) is a technique within the
diffusion-weighted MRI that has recently emerged strongly. This image technique
contribute to the characterization of a tumor, for example to what extent
microperfusion and diffusion is present in tissue or tumor. This study will be
investigated becaus IVIM parameters vary between tissues in head and neck and
this is not previously described in literature, especially for low B values*.
The main problem of imaging in the head-neck area is the inhomogeneity of the
magnetic field. This is expected to be greatly improved by draining a
fluid-filled pillow around the neck, so that there are fewer air-tissue
transitions near the neck region. This fluid contains manganese (pineapple)
juice to reduce T2 time, so that the liquid does not give an excessively strong
signal that can complicate the assessment of the MRI images of the neck.
Study objective
Primary objective:
- Optimization of MR diffusion quality in head and neck squamous cell carcinoma
by an extension of the scan protocol and a pillow filled with pineapple juice.
Secundary objective:
- To determine the most optimal amount and distribution of b-values to obtain a
good bi-exponential fit with IVIM.
- To determine IVIM-parameters of normal tissue of different
areas/structures in head and neck
- To test the reproducibility of IVIM parameters in healty heak and neck
tissue.
Study design
Observational
Study burden and risks
Patients has to lie still for about 6 minutes after the normal MRI, without
risks or benifits.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Healthy volunteer
o No surgical/oncological history in head & neck region;- Patient with head and neck cancer
o Bulky T2, T3, T4 squamous cell carcinoma;- Acquired written informed consent
Exclusion criteria
- Contraindications MRI
- Pregnancy
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 | NL59736.029.16 |