MRI Perfusion on T1 and T2 Brain Lesion(s) (METAPERF)
Primary Purpose
Lung Carcinoma Metastatic to the Brain
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI T1 T2 sequences
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Carcinoma Metastatic to the Brain focused on measuring MRI perfusion, therapeutic response, chemotherapy, brain metastases
Eligibility Criteria
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
Sites / Locations
- Hopital Salengro CHRU de Lille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRI T1 T2 sequences
Arm Description
comparison of perfusion sequences T1 T2 in patients with brain metastase cancer
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Radiological progression-free survival
Comparison of the ability of the two sequences to predict infusion:
Survival without neurological signs
Comparison of the ability of the two sequences to predict infusion:
Full Information
NCT ID
NCT02250755
First Posted
June 5, 2014
Last Updated
November 3, 2015
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT02250755
Brief Title
MRI Perfusion on T1 and T2 Brain Lesion(s)
Acronym
METAPERF
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Carcinoma Metastatic to the Brain
Keywords
MRI perfusion, therapeutic response, chemotherapy, brain metastases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI T1 T2 sequences
Arm Type
Experimental
Arm Description
comparison of perfusion sequences T1 T2 in patients with brain metastase cancer
Intervention Type
Other
Intervention Name(s)
MRI T1 T2 sequences
Intervention Description
MRI
Primary Outcome Measure Information:
Title
Comparing different parameters evaluated in T1 and T2 * perfusion
Description
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
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Evaluation tumor response
Description
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
Time Frame
1 year
Title
Radiological progression-free survival
Description
Comparison of the ability of the two sequences to predict infusion:
Time Frame
1 year
Title
Survival without neurological signs
Description
Comparison of the ability of the two sequences to predict infusion:
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier LECLERC, Professor
Organizational Affiliation
CHRU of Lille
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Salengro CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
12. IPD Sharing Statement
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MRI Perfusion on T1 and T2 Brain Lesion(s)
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