MRI Perfusion on T1 and T2 Brain Lesion(s)

NCT ID: NCT02250755

Last Updated: 2015-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-11-30

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

Conditions

Lung Carcinoma Metastatic to the Brain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MRI T1 T2 sequences

comparison of perfusion sequences T1 T2 in patients with brain metastase cancer

Group Type: EXPERIMENTAL

MRI T1 T2 sequences

Intervention Type: OTHER

MRI

Interventions

MRI T1 T2 sequences

MRI

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xavier LECLERC, Professor

Role: STUDY_DIRECTOR

CHRU of Lille

Locations

Hopital Salengro CHRU de Lille

Lille, , France

Countries

France

Other Identifiers

2012-A01644-39

Identifier Type: OTHER

Identifier Source: secondary_id

2012_27

Identifier Type: -

Identifier Source: org_study_id