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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
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 5, 2014
Last Updated
November 3, 2015
Sponsor
University Hospital, Lille
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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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