|- candidate number||13363|
|- NTR Number||NTR3628|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-sep-2012|
|- Secondary IDs||12-4-126 METC acM/UM|
|- Public Title||Screening for brain metastasis in patients with stage III Non-Small Cell Lung Cancer: Has Magnetic Resonance Imaging an additive value compared to contrast enhanced Computed Tomography of the brain Incorporated in the staging whole body 18FDG-PET-CT scanning?|
|- Scientific Title||Screening for brain metastasis in patients with stage III Non-Small Cell Lung Cancer: Has Magnetic Resonance Imaging an additive value compared to contrast enhanced Computed Tomography of the brain Incorporated in the staging whole body 18FDG-PET-CT scanning?|
|- hypothesis||We hypothesise that there is no clinically relevant additive value of post contrast MRI to contrast enhanced computed tomography (CE-CT) of the brain when both are performed in standard work-up, including 18FDG-PET-CE-CT, in detecting asymptomatic brain metastasis.
Clinically relevant is defined by our study group as: additional brain metastasis found on MRI in more than two out of one hundred patients who have a negative 18FDG-PET-CE-CT. We base this number on the fact that already up to 15% of stage III NSCLC patients develop symptomatic brain metastasis within a year after an initial negative MRI.
|- Healt Condition(s) or Problem(s) studied||Non small cell lung cancer (NSCLC), Brain metastases, MRI, FDG-PET|
|- Inclusion criteria||1. Pathology proven NSCLC;|
2. UICC stage III;
3. Eligible for therapy with curative intent;
4. Staging based on 18FDG-PET-CE-CT;
5. No contra-indication for MRI or CE-CT;
6. MRI within 3 weeks after 18FDG-PET-CE-CT.
|- Exclusion criteria||1. Other malignancy that is not controlled or that was diagnosed less than 2 years before enrolment in this study, except skin cancer or cervical cancer in situ;|
2. Contra-indication for MRI or CE-CT;
3. Mixed histologies such as combined small cell and non-small cell lung cancer;
4. Recurrent disease only if not eligible for therapy with curative intent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-okt-2012|
|- planned closingdate||1-mei-2014|
|- Target number of participants||118|
|- Interventions||None, observational. |
|- Primary outcome||Number of patients with additional brain metastasis found on MRI after negative CE-CT.|
|- Secondary outcome||1. Asymptomatic brain metastasis found on 18FDG-PET-CE-CT in otherwise stage III NSCLC patients;|
2. Cost analysis;
3. Number of patients with symptomatic brain metastasis within a year after an initially negative MRI and time to symptomatic brain metastasis.
|- Timepoints||Follow up will be one year.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD PhD Anne-Marie C. Dingemans|
|- CONTACT for SCIENTIFIC QUERIES||MD PhD Anne-Marie C. Dingemans|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|Maastricht University Medical Center (MUMC+)|
|- Publications||Data will be published within a year after the study is finished. According to the CCMO guidelines.|
|- Brief summary||In current NSCLC guidelines imaging of the brain is advised in all stage III patients eligible for therapy with curative intent. MRI is preferred to contrast enhanced CT of the brain (CE-CT), but this advise is based on older studies. These studies did not include only (stage III) NSCLC nor 18FDG-PET. In a recently performed retrospective study using up-to-date MRI and CT techniques, no additional brain metastasis were found on MRI in patients with stage III NSCLC after 18FDG-PET-CT with CE-CT of the brain. Moreover, in most hospitals MRI availability is scarce and MRI is difficult to obtain within a reasonable time scale. Also, MRI adds extra costs to the diagnostic evaluation. Finally, there are also some contra-indications for MRI, for example intracorporal metallic objects, pacemakers and claustrophobia.
Although it is known that MRI of the brain is more sensitive than a CE-CT, it is unclear whether this is still the case in the setting of excluding brain metastasis in neurological asymptomatic patients with stage III NSCLC.
The question whether post contrast MRI offers a benefit to CE-CT in the initial staging of patients with NSCLC has become more urgent in view of the increasing wide-spread use of 18FDG-PET-CT scanners. If CE-CT performed in the same setting as 18FDG-PET-CT could lead to the same yield of brain metastasis detection as 18FDG-PET-CT with LD-CT and separately a post contrast MRI, a substantial gain in time and resources can be expected without increasing the radiation dose and quantity of contrast agent administered to the patient.
We hypothesise that there is no clinically relevant additive value of post contrast MRI to CE-CT of the brain when both are performed in standard work-up, including 18FDG-PET-CE-CT, in detecting asymptomatic brain metastasis.
|- Main changes (audit trail)|
|- RECORD||24-sep-2012 - 7-nov-2012|