NCT05977803

Brief Summary

The aim of the study is to determine whether the use of the CEST sequence would have diagnostic performance equivalent to the reference method of T2\* infusion with contrast injection in the diagnosis of radionecrosis of lung cancer brain metastases.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
35mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Feb 2024Mar 2029

First Submitted

Initial submission to the registry

June 21, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2029

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2029

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

June 21, 2023

Last Update Submit

March 26, 2026

Conditions

Brain MetastasesRadionecrosisPulmonary Cancer

Keywords

radionecrosis, metastases,

Outcome Measures

Primary Outcomes (1)

  • Visually significant hyperperfusion on normalized cerebral blood flow mapping generated from T2* infusion data with injection, confirmed by quantitative measurement of a ratio > 2.5 between tumor DSC and contralateral white matter.

    Diagnostic performance of the CEST sequence in the diagnosis of radionecrosis on irradiated metastases of primary lung cancer compared to injected T2\* infusion sequence

    24 months

Secondary Outcomes (7)

  • Diagnostic performances for the IVIM sequence using IVIM scattering derivatives: f', ADC

    24 months

  • Diagnostic performances for the ASL (arterial spin labeling) sequence using ASL infusion derivatives: intralesional CBF (cerebral blood flow) relative to contralateral white matter CBF

    24 months

  • Diagnostic performances of coupled CEST, IVIM and ASL sequences, evaluated by the derivates of the CEST sequence : APT-AUC (Area Under Curve), NOE-MTR (Magnetization Transfer Ratio) and NOE-AUC.

    24 months

  • Diagnostic performances of coupled CEST, IVIM and ASL sequences, evaluated by the derivates of the IVIM scattering : f', ADC

    24 months

  • Diagnostic performance of coupled CEST, IVIM and ASL sequences, evaluated by the derivates of the ASL infusion : intralesional CBF (cerebral blood flow) relative to contralateral white matter CBF

    24 months

  • +2 more secondary outcomes

Study Arms (1)

Radiation therapy

OTHER

Patient treated for metastatic cerebral lung cancer who has been treated with external beam radiotherapy such as in toto brain irradiation or stereotactic radiosurgery followed in the thoracic oncology department of Bichat Hospital.

Radiation: MRI with CEST sequence, IVIM and ASL sequence

Interventions

MRI with CEST sequence, IVIM and ASL sequenceRADIATION

Three sequences will be added as part of the protocol (for an additional duration of about 10 minutes) : * The CEST sequence * The ASL infusion sequence * The IVIM sequence

Radiation therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \> 18 years of age
  • Histologically proven primary lung cancer
  • Histologically proven or not brain metastases
  • Irradiated metastases
  • Morphological increase of one or more lesions of secondary brain metastases on a follow-up MRI
  • Patients affiliated to a social security scheme

You may not qualify if:

  • Opposition to the study
  • Contraindication to MRI
  • Refusal of imaging by the patient
  • Patient with state medical aid (unless exemption from affiliation)
  • Severe cognitive impairment making informed consent impossible
  • Patients under guardianship or deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Bichat-Claude Bernard

Paris, 75018, France

RECRUITING

MeSH Terms

Conditions

Brain NeoplasmsLung NeoplasmsNeoplasm Metastasis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Augustin Gaudemer, MD

    Assistance Publique Hopitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Augustin Gaudemer, MD

CONTACT

01 40 25 76 13augustin.gaudemer@aphp.fr

Marie-Cécile Henry-Feugeas, MD

CONTACT

01 40 25 81 52marie-cecile.henry-feugeas@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2023

First Posted

August 4, 2023

Study Start

February 15, 2024

Primary Completion (Estimated)

February 15, 2029

Study Completion (Estimated)

March 15, 2029

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

FR(1)