- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02250755
MRI Perfusion on T1 and T2 Brain Lesion(s) (METAPERF)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Eligibility criteria:
- Major Patients
- Addressed MRI for initial assessment of brain metastases
- At a suspicion of one or more brain metastases in the brain scanner routine screening
- Follow for lung cancer histologically documented
- In the Thoracic Oncology Service Professor Lafitte (contact: Dr Cortot)
- To whom treatment with chemotherapy or targeted therapy (including anti-angiogenic) is considered
- Be socially insured
Main Outcomes measures:
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 response evaluated at 1 year
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lille, France, 59037
- Hopital Salengro CHRU de Lille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MRI T1 T2 sequences
comparison of perfusion sequences T1 T2 in patients with brain metastase cancer
|
MRI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparing different parameters evaluated in T1 and T2 * perfusion
Time Frame: 3 years
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation tumor response
Time Frame: 1 year
|
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
|
|
Radiological progression-free survival
Time Frame: 1 year
|
Comparison of the ability of the two sequences to predict infusion:
|
1 year
|
|
Survival without neurological signs
Time Frame: 1 year
|
Comparison of the ability of the two sequences to predict infusion:
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Xavier LECLERC, Professor, CHRU of Lille
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012_27
- 2012-A01644-39 (Other Identifier: ID RCB number, ANSM)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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