NCT02977663UnknownNot Applicable
Imaging Multiparametric/Multimodality (Magnetic Resonance Imaging Combined With Positron Emission Tomography) for Lungcancer
Assistance Publique - Hôpitaux de Paris1 site in 1 country200 target enrollmentStarted: August 28, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Event-free survival of patients with lungcancer
Study Overview
Brief Summary
- To build an imaging biobank of 200 patients with lungcancer, including pathologic and molecular characteristics of the tumor (mutational status, circulating DeoxyriboNucleic Acid (DNA) from serum biobank...), staging of the cancer (according to the new 2016 Tumor Node Metastasis (TNM) status, the table that classify non-small cell lungcancer) and follow-up informations (Response to first-line treatment (Response Evaluation Criteria in Solid Tumors (RECIST)), disease-free survival, 1-3 years survival).
- To propose a simple severity scoring system based on tumor features such as size, doubling time (if available), location, amount of enhancement and necrosis. Such approach has been proposed for glioma evaluation (Visually Accessible Rembrandt Images (VASARI)) but is not available for the lung. The objective is to do better than the Tumor Node Metastasis (TNM) staging.
- To develop and evaluate an IntraVoxel Incoherent Motion (IVIM) protocol for lungcancer evaluation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults over 18 years
- •High suspicion of lungcancer confirmed
- •Tumor > 2 cm
- •Incomplete cerebral staging or not yet realized in the initial consultation of screening
Exclusion Criteria
- •Lungcancer medical history
- •During Pregnancy
- •Contraindications to MRI
- •Patient not able to understand the information of the protocol, taking into account the state of the brain
- •Patient unable to keep lying in MRI the necessary time
Arms & Interventions
Magnetic Resonance Imaging (MRI)
Other
Thoracic Magnetic Resonance Imaging (MRI)
Intervention: Magnetic Resonance Imaging (MRI) (Other)
Outcomes
Primary Outcomes
Event-free survival of patients with lungcancer
Time Frame: 3 years
Secondary Outcomes
- Overall survival(3 months, 1 year, 2 years and 3 years)
- Number of patients by histologic subtypes(3 months, 1 year, 2 years and 3 years)
- Number of patients by mutational profile(3 months, 1 year, 2 years and 3 years)
- Number of patients with metastases(3 months, 1 year, 2 years and 3 years)
- Number of metastases by patient(3 months, 1 year, 2 years and 3 years)
- Therapeutic responses assessed by scanner/MRI and/or Positron Emission Tomography (PET) based on consensus criteria (RECIST 1.1 and PET Response Criteria in Solid Tumors (PERCIST))(3 months, 1 year, 2 years and 3 years)
- Number of patients with brain metastases(3 months, 1 year, 2 years and 3 years)
Investigators
Study Sites (1)
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