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Multiparametric PET-MRI Integration for a New Approach to Tumor Heterogeneity in Non-Small Cell Lung Cancer (NSCLC): Pilot Study (IMAHTEP)

Primary Purpose

NSCLC

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PET-MRI
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for NSCLC

Eligibility Criteria

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

Inclusion Criteria:

  1. Locally advanced NSCLC (stages IIB, IIIA or IIIB of the TNM classification 7th edition) or trace metastatic stage IV (</=5 mestastasis, </= 3 organ reached)
  2. Exclusive therapeutic management by concomitant radio-chemotherapy administered in accordance with international recommendations (dual therapy with platinum salts)
  3. Signed consent
  4. Patients affiliated with the social security scheme or beneficiary of a similar scheme.

Exclusion Criteria:

  1. Minor
  2. Pregnant / lactating woman
  3. Person deprived of liberty by judicial or administrative decision, adults who are the subject of a legal protection measure or unable to express their consent
  4. Previous cancer in the 2 years prior to registration
  5. Previousradiotherapy / thoracic surgery
  6. Patients under experimental treatment or for whom the administration of an experimental treatment is planned
  7. Claustrophobic patients
  8. Severe Renal Insufficiency (Clearance MDRD Cockroft <30ml / min)
  9. Uncontrolled diabetes, hyperglycemia> 1.8g / L
  10. Patient with metallic implants not compatible with MRI or any immovable implanted electronic medical device (eg pacemaker, neurostimulator, cochlear implants, etc.)

Sites / Locations

  • Gustave RoussyRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with NSCLC

Arm Description

Characterization of tumor heterogeneity by multiparametric regional mapping PET-MRI. Patients will realize: a PET-MRI examination performed before the chemoradiotherapy treatment (so-called baseline PET-MRI) a PET-MRI examination performed midway through treatment (PET-MRI1 under treatment), after receiving 33 ± 4 Gy (approximately 2.5 months after the first PET-MRI).

Outcomes

Primary Outcome Measures

Measurement of intra and inter-operator reproducibility of multiparametric regional PET-MRI mapping performed before and under treatment.

Secondary Outcome Measures

Full Information

First Posted
July 20, 2018
Last Updated
January 2, 2019
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03606070
Brief Title
Multiparametric PET-MRI Integration for a New Approach to Tumor Heterogeneity in Non-Small Cell Lung Cancer (NSCLC): Pilot Study
Acronym
IMAHTEP
Official Title
Multiparametric PET-MRI Integration for a New Approach to Tumor Heterogeneity in Non-Small Cell Lung Cancer (NSCLC): Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 25, 2017 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To estimate the intra and inter-operator reproducibility of multiparametric regional PET-MRI mapping in locally advanced and trace mestastatic non-small cell lung cancer (NSCLC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with NSCLC
Arm Type
Other
Arm Description
Characterization of tumor heterogeneity by multiparametric regional mapping PET-MRI. Patients will realize: a PET-MRI examination performed before the chemoradiotherapy treatment (so-called baseline PET-MRI) a PET-MRI examination performed midway through treatment (PET-MRI1 under treatment), after receiving 33 ± 4 Gy (approximately 2.5 months after the first PET-MRI).
Intervention Type
Diagnostic Test
Intervention Name(s)
PET-MRI
Intervention Description
a PET-MRI examination performed before the chemoradiotherapy treatment (so-called baseline PET-MRI) a PET-MRI examination performed midway through treatment (PET-MRI1 under treatment), after receiving 33 ± 4 Gy (approximately 2.5 months after the first PET-MRI).
Primary Outcome Measure Information:
Title
Measurement of intra and inter-operator reproducibility of multiparametric regional PET-MRI mapping performed before and under treatment.
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Locally advanced NSCLC (stages IIB, IIIA or IIIB of the TNM classification 7th edition) or trace metastatic stage IV (</=5 mestastasis, </= 3 organ reached) Exclusive therapeutic management by concomitant radio-chemotherapy administered in accordance with international recommendations (dual therapy with platinum salts) Signed consent Patients affiliated with the social security scheme or beneficiary of a similar scheme. Exclusion Criteria: Minor Pregnant / lactating woman Person deprived of liberty by judicial or administrative decision, adults who are the subject of a legal protection measure or unable to express their consent Previous cancer in the 2 years prior to registration Previousradiotherapy / thoracic surgery Patients under experimental treatment or for whom the administration of an experimental treatment is planned Claustrophobic patients Severe Renal Insufficiency (Clearance MDRD Cockroft <30ml / min) Uncontrolled diabetes, hyperglycemia> 1.8g / L Patient with metallic implants not compatible with MRI or any immovable implanted electronic medical device (eg pacemaker, neurostimulator, cochlear implants, etc.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline CARAMELLA, MD
Phone
0142114211
Ext
+33
Email
caroline.caramella@gustaveroussy.fr
Facility Information:
Facility Name
Gustave Roussy
City
Villejuif
State/Province
Val De Marne
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline CARAMELLA, MD
Phone
0142114211
Email
caroline.caramella@gustaveroussy.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Multiparametric PET-MRI Integration for a New Approach to Tumor Heterogeneity in Non-Small Cell Lung Cancer (NSCLC): Pilot Study

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