Imaging Multiparametric/Multimodality for Lungcancer | NCT02977663

Studies
Imaging Multiparametric/Multimodality for Lungcancer

NCT02977663

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Jan 8, 2021Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Lungcancer

Interventions

Magnetic Resonance Imaging (MRI)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ANSM	Registry Identifier	N° ID RCB : 2016-A00813-48

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 28, 2017Actual

Primary Completion Date

Aug 2022Estimated

Completion Date

Aug 2023Estimated

First Submitted Date

Nov 10, 2016

First Submission Date that Met QC Criteria

Nov 25, 2016

First Posted Date

Nov 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2021

Last Update Posted Date

Jan 8, 2021Actual

Name	Class
General Electric	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Magnetic Resonance Imaging (MRI)	Other	Thoracic Magnetic Resonance Imaging (MRI)	Other: Magnetic Resonance Imaging (MRI)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnetic Resonance Imaging (MRI)	Other	Chest MRI during the MRI cerebral 2 tubes of blood taken during the medical visit	Magnetic Resonance Imaging (MRI)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Event-free survival of patients with lungcancer		3 years

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sabine Helfen	Contact	33148957732		sabine.helfen@aphp.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BRILLET	Recruiting	Bobigny		93000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided