Healthy volunteers* To select the appropriate techniques to image lung and mediastinal parenchyma. Furthermore, MRI settings will be sought which can be used for motion compensation.Patients* To optimize and validate MRI for the visualization and…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Healthy volunteers:
Quality of the scans will be assessed by rating the motion artifacts and
visibility of the lung and mediastinal parenchyma.
* Patients with stage III NSCLC:
Optimization of lung MRI for radiotherapy purposes (i.e. tumor delineation and
motion characterization) defined by the quality of the images. Quality will be
assessed by rating of the scans regarding the visibility of the primary tumor,
lymph nodes and mediastinal parenchyma.
Secondary outcome
The results of this optimization study will be used for the power analysis of
consecutive studies.
Background summary
Patients with stage III non-small cell lung cancer (NSCLC) have a poor survival
due to inadequate loco-regional control. Increasing the dose will lead to
better loco-regional control and survival. However, with the current treatment
planning strategies, increasing this dose would result in intolerable toxicity
of the organs at risk (OARs, healthy tissue surrounding the tumor).Therefore,
new treatment planning strategies have to be developed to improve local control
and therefore overall survival of patients with stage III NSCLC.
Currently, the radiation oncologist uses a combination of imaging modalities
for the delineation of the lung tumor and lymph nodes: 4D- computed tomography
(CT) scan, CT-scan with intravenous contrast and the positron emission
tomography(PET)-CT with fluorodeoxyglucose as a radioactive tracer. However
these imaging modalities have some disadvantages.In current clinical practice,
large treatment volumes are irradiated. This results in an increased dose to
OARs. Consequently, further increasing of the dose to the tumor would result in
intolerable toxicity.
We believe that MRI can be used to improve visualization of the tumor and lymph
nodes and characterize their motion, based on promising results in recent
literature. MRI can potentially be used to obtain more accurate (thus smaller)
treatment volumes. This will lead to a smaller dose to the OARs and enable safe
dose escalation.
Unfortunately there are no MRI protocols in the literature available aimed at
radiotherapy of lung cancer.
The objective of this study is twofold. We would first like to use MRI in
volunteers to select the appropriate techniques for motion compensation.
Furthermore, MRI settings will be sought which can be used to image lung and
mediastinal parenchyma. Second, we would like to assess the MRI sequences found
in volunteers for the visualization of tumors and lymph nodes in patients with
stage III NSCLC.
Furthermore, we would like to assess if MRI can be used for (automatic) motion
characterization of tumor, lymph nodes and organs at risk.
The sequences found in this study will be used in a future study on the added
value of MRI for radiotherapy treatment planning of stage III NSCLC, in which
MRI will also be compared to PET-CT.
Study objective
Healthy volunteers
* To select the appropriate techniques to image lung and mediastinal
parenchyma. Furthermore, MRI settings will be sought which can be used for
motion compensation.
Patients
* To optimize and validate MRI for the visualization and motion
characterization of tumor, lymph nodes and mediastinal parenchyma in patients
with stage III NSCLC.
Study design
Observational study: 20 volunteers will receive an MRI-scan without contrast
and 20 patients with stage III NSCLC will receive a contrast-enhanced MRI-scan.
Study burden and risks
* Healthy volunteers will undergo an MRI scan with a maximal duration of 45
minutes. One visit to the hospital (lasting approximately 75 minutes) is
required and the healthy volunteers will receive a gift voucher with a value of
25 euros. MRI-safety screening is required before the MRI scan, and consists of
routine screening according to the clinical guidelines as determined by the
Department of Radiology of the UMCU.
* Patients will undergo an MRI scan with a maximal duration of 45 minutes. The
total visit to the department (including patient preparation, changing of
clothes etc.) will last approximately 75 minutes. For determination of renal
function, a recent value of the Glomerular Filtration Rate (GFR) (* 3 months)
has to be available.
After proper screening, the use of MRI is safe. The use of gadolinium contrast
(Gadovist) has a very low risk of contrast induced allergy.
For the patients included in the study there is no individual benefit.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteers
- *18 years
- written informed consent;Patients:
- patients with histopathologically or cytologically proven stage III NSCLC (excluding T4N0) referred to the department of Radiation Oncology
- * 18 years
- written informed consent
- recent (* 3 months) GFR value available
Exclusion criteria
Healthy volunteers:
- volunteers who meet exclusion criteria for MRI following the protocol of the department of Radiology of the UMC Utrecht;Patients:
- patients who meet exclusion criteria for MRI following the protocol of the department of Radiology of the UMC Utrecht
- patients for whom lying still in a supine position for 45 minutes is physically too strenuous (e.g. due to orthopnea)
- Glomerular Filtration Rate (GFR) of <30 mL/min/1.73m2 (UMCU protocol *MRI Contra-indicaties*, Version 3 January 2013)
- patients with nephrogenic systemic fibrosis, nephrogenic fibrosing dermopathy or severe renal insufficiency (UMCU protocol *MRI Contra-indicaties*, Version 3 January 2013)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL46711.041.13 |
OMON | NL-OMON27984 |