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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)

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ClinicalTrials.gov Identifier: NCT03606070
Recruitment Status : Unknown
Verified January 2019 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
First Posted : July 30, 2018
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Study Description
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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).

Condition or disease Intervention/treatment Phase
NSCLC Diagnostic Test: PET-MRI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multiparametric PET-MRI Integration for a New Approach to Tumor Heterogeneity in Non-Small Cell Lung Cancer (NSCLC): Pilot Study
Actual Study Start Date : November 25, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Patients with NSCLC

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).
 Diagnostic Test: PET-MRI
  • 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).


Outcome Measures
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Primary Outcome Measures :
  1. Measurement of intra and inter-operator reproducibility of multiparametric regional PET-MRI mapping performed before and under treatment. [ Time Frame: Up to 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606070


Contacts
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Contact: Caroline CARAMELLA, MD 0142114211 ext +33 caroline.caramella@gustaveroussy.fr

Locations
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France
Gustave Roussy Recruiting
Villejuif, Val De Marne, France, 94805
Contact: Caroline CARAMELLA, MD    0142114211    caroline.caramella@gustaveroussy.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
More Information
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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT03606070    
Other Study ID Numbers: 2016-A02074-47
2016/2499 ( Other Identifier: CSET number )
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases