To assess the impact on treatment decision of a screening MRI brain in asymptomatic patients with newly diagnosed stage IV non-oncogene addicted NSCLC, fit for systemic treatment.
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical value of the MRI evaluated by the treating thoracic oncologist to
assess the impact on treatment decision of a screening MRI brain in
asymptomatic patients with newly diagnosed stage IV non-oncogene addicted
NSCLC, fit for systemic treatment.
Secondary outcome
We aim to assess incidence of brain disease, the clinical course of brain
metastasis, related symptoms and treatment received in patients with positive
and negative screenings MRI throughout the course of disease. We will also
perform a cost-benefit analysis of the baseline MRI brain scan in this study
population.
Background summary
Brain metastases frequently arise in patients with lung cancer. They are
associated with poor quality of life (QoL) and decreased survival. Patients
with brain metastasis are usually excluded from clinical trials, despite the
need for improved and more personalized treatment. Knowledge of the presence of
asymptomatic brain metastases in the standard of care setting would be of great
value to initiate adequate and timely treatment before symptoms arise thereby
potentially prolonging the period with a good QoL and survival.
Study objective
To assess the impact on treatment decision of a screening MRI brain in
asymptomatic patients with newly diagnosed stage IV non-oncogene addicted
NSCLC, fit for systemic treatment.
Study design
Prospective, single center cohort study.
Before start of standard of care treatment, an MRI of the brain will be
conducted to screen for brain disease. In case of brain metastases, treatment
will be discussed in the multidisciplinary tumor board as part of standard of
care. The treating thoracic oncologist will be asked to complete questionnaires
regarding therapy and the value of the scan at three time points, before (<3
weeks), right after (<= 3 weeks) and a while after (3-6 months) the MRI.
Study burden and risks
Patients participating in this study will have an extra MRI of the brain
(approximately 40 min). This potentially can cause psychological distress.
If feasible, the scan will be planned together with standard of care
evaluations to minimize burden for the patient. In case of a separate
appointment for the trial, travel and parking costs will be reimbursed.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
•Capable of giving signed informed consent.
•Age >=18 years at the time of screening.
•Histologically or cytologically confirmed stage IV metastatic NSCLC, not
amenable to curative treatment.
•Fit for systemic treatment (PS 0-2) according to standard of care.
•No symptoms of brain disease assessed according to standard clinical care by
the thoracic oncologist.
Exclusion criteria
•Prior/concomitant therapy for stage IV disease.
•Oncogenic diver mutation (e.g. EGFR, ALK, ROS1, RET, MET, and BRAF) with
approved targeted treatment.
•Contraindications for MRI scan with contrast as per standard of care protocol
of the institution.
Design
Recruitment
Medical products/devices used
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 | NL84338.042.23 |