Lung Carcinoma Metastatic to the Brain Clinical Trial
— METAPERFOfficial title:
Comparison of MRI Sequences T1 and T2 * Cerebral Perfusion to Aid in the Diagnosis and Evaluation of Brain Therapeutic Response With Chemotherapy or Targeted Therapy(s) Lesion(s) in Patients Treated and Followed for a Pulmonary Neoplasia
This study therefore aims to assess current treatment recommended by scientific societies [
6-13 ] , brain MRI with injection of contrast for the diagnosis and monitoring of brain
metastases . The recommended dose of this examination gadolinium is from 0.1 to 0.3 mmol /
kg [ 14 ] . Sequences infusion different from one center to the other made : some use the
infusion T1, other infusion T2 * . No recommendation establishes whether it is preferable to
use one or the other of these sequences.
No examination is added for the purposes of protocol. Indications for MRI and the number and
timing of MRI checks under this protocol are consistent with what is done in practice . The
used type of gadolinium and the injected dose will be identical for both sequences infusion
. The assessment shall not in any case the contrast but the interpretation of the sequence
itself. Special procedures monitoring implemented embodiment correspond to the two sequences
instead of infusion (one of T1-weighted and T2 * in the other ) , in the original MRI and
MRI of the first control , in order to compare their effectiveness
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | November 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Major Patients - Addressed to MRI for initial assessment of brain metastases - At a suspicion of one or more brain metastases in the brain scanner routine screening - Followed for lung cancer histologically documented in the Thoracic Oncology Service of Professor Lafitte (contact: Dr Cortot) - To whom treatment with chemotherapy or targeted therapy (including anti-angiogenic) is considered - Be socially insured- Exclusion Criteria: - Absolute contraindication to MRI (pacemaker, implantable pacemaker, metallic foreign body intraorbital) - Patients minors under guardianship / curatorship - Patients with impaired judgment skills or unable to receive information - Pregnant Women - Patients for which lesions are not compatible with lung metastases - Patients with brain metastases or already known and explored MRI - Patients for whom treatment by surgical excision of brain metastases is considered |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| France | Hopital Salengro CHRU de Lille | Lille |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Lille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Comparing different parameters evaluated in T1 and T2 * perfusion | Comparing the area under the ROC curve of different parameters evaluated in T1 and T2 * perfusion during the initial assessment for the diagnosis of maximal tumor | 3 years | No |
| Secondary | Evaluation tumor response | Comparison of the area under the ROC curve of the change in the first control of the various parameters measured in T1 and T2 * infusion, for the diagnosis of maximum tumor response evaluated at 1 year | 1 year | No |
| Secondary | Radiological progression-free survival | Comparison of the ability of the two sequences to predict infusion: | 1 year | No |
| Secondary | Survival without neurological signs | Comparison of the ability of the two sequences to predict infusion: | 1 year | No |