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OpenTrials
Terminated

NCT Number: NCT03606070

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

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).

Why the study stopped: Lack of inclusion
Terminated

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

PET-MRI

Diagnostic Test
  • 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Acronym: IMAHTEP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 30, 2018
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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