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Contribution of the CEST Sequence in the Characterization of Radionecrosis of Brain Metastases of Pulmonary Origin (ACROP)

Primary Purpose

Brain Metastases, Radionecrosis, Pulmonary Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI with CEST sequence, IVIM and ASL sequence
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Metastases focused on measuring radionecrosis, metastases,

Eligibility Criteria

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

Inclusion Criteria: Patients > 18 years of age Histologically proven primary lung cancer Histologically proven or not brain metastases Irradiated metastases Inclusion in a treatment protocol for brain metastases by brain metastasis in toto or stereotactic or gamma-knife radiotherapy Morphological increase of one or more lesions of secondary brain metastases on a follow-up MRI Patients affiliated to a social security scheme Exclusion Criteria: 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

Sites / Locations

  • Hôpital Bichat-Claude Bernard

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Radiation therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Diagnostic performances for the IVIM sequence using IVIM scattering derivatives: f', ADC
Diagnostic performances for the ASL (arterial spin labeling) sequence using ASL infusion derivatives: intralesional CBF (cerebral blood flow) relative to contralateral white matter CBF
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.
Diagnostic performances of coupled CEST, IVIM and ASL sequences, evaluated by the derivates of the IVIM scattering : f', ADC
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
Tolerance of acquisition of all CEST, IVIM and ASL sequences evaluated by the percentage of exams interrupted.
Describtion of non-tumor white matter changes in the irradiation field and outside the CEST sequence irradiation field during follow-up

Full Information

First Posted
June 21, 2023
Last Updated
August 3, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05977803
Brief Title
Contribution of the CEST Sequence in the Characterization of Radionecrosis of Brain Metastases of Pulmonary Origin
Acronym
ACROP
Official Title
Contribution of the CEST Sequence in the Characterization of Radionecrosis of Brain Metastases of Pulmonary Origin
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

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

5. Study Description

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.
Detailed Description
Brain metastases are frequent secondary sites in the evolution of cancers, with an incidence of all cancers combined of about 20% and up to 40% in the later phases of the disease. Among these metastases, the lung is the most common primary lesion (responsible for 20-56% of brain metastases). The overall prognosis for metastatic brain cancers is poor, with treatment-free survival of 1 to 2 months, and with treatment averaging 7-8 months. Their treatment is based on systemic medical treatment (chemotherapy, immunotherapy or targeted therapy depending on the status of the lesion) and on the other hand on the response to local treatment (surgery or radiotherapy). Radiotherapy is performed either as a first-line or post-operative depending on the resectability of the lesions and the operability of the patient. Radionecrosis is a late complication (6 months to 2 years on average) and frequent (5-25%) of stereotactic radiotherapy. It may be promoted by the concomitant use of immunotherapy such as checkpoint inhibitors, which implies a probable increase in its incidence. Treatment of radionecrosis is based on corticosteroids; recent studies also propose Bevacizumab. The distinction in MRI between tumor progression and radionecrosis is based on a multimodal approach. Indeed, conventional sequences alone have average performance (sensitivity 76% and specificity 59%). Several MRI methods have been evaluated, but their performance varies according to the studies. Cerebral perfusion is the most widely used method, requiring contrast injection with correct performance. However, there is no standardized perfusion value to directly extrapolate these results. MRI spectroscopy has also been studied, with correct performance but only evaluated on weak samples and retrospectively. CEST is an MRI technique that uses endogenous contrast, i.e. does not require injection of contrast medium. It consists of specifically altering the signal of a molecular compound by causing saturation (i.e. cancellation of its signal) and studying the saturation of the solute (i.e. water) on contact. Indeed, due to a process called 'chemical saturation transfer', the signal from the water in contact with the targeted compound will also become partially saturated. The subtraction of the MRI signals acquired before and after saturation makes it possible to obtain a tissue mapping of the molecular compound initially targeted obtaining an indirect reflection of its concentration. Indeed, the macromolecular composition of tissues (inaccessible for physical reasons in spectroscopy) differs according to radionecrosis status or tumor progression, with more ""amide"" compounds in the second case. This relatively recent development technique has been studied in primary and secondary brain tumors, especially in the context of radionecrosis, but mainly in primary brain tumors. It seems to allow a more precise and earlier detection of possible tumor progressions. The diagnosis of radionecrosis is therefore a major step forward for the management of patients with irradiated brain metastases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases, Radionecrosis, Pulmonary Cancer
Keywords
radionecrosis, metastases,

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Radiation therapy
Arm Type
Other
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
MRI with CEST sequence, IVIM and ASL sequence
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Description
Diagnostic performance of the CEST sequence in the diagnosis of radionecrosis on irradiated metastases of primary lung cancer compared to injected T2* infusion sequence
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Diagnostic performances for the IVIM sequence using IVIM scattering derivatives: f', ADC
Time Frame
24 months
Title
Diagnostic performances for the ASL (arterial spin labeling) sequence using ASL infusion derivatives: intralesional CBF (cerebral blood flow) relative to contralateral white matter CBF
Time Frame
24 months
Title
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.
Time Frame
24 months
Title
Diagnostic performances of coupled CEST, IVIM and ASL sequences, evaluated by the derivates of the IVIM scattering : f', ADC
Time Frame
24 months
Title
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
Time Frame
24 months
Title
Tolerance of acquisition of all CEST, IVIM and ASL sequences evaluated by the percentage of exams interrupted.
Time Frame
24 months
Title
Describtion of non-tumor white matter changes in the irradiation field and outside the CEST sequence irradiation field during follow-up
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients > 18 years of age Histologically proven primary lung cancer Histologically proven or not brain metastases Irradiated metastases Inclusion in a treatment protocol for brain metastases by brain metastasis in toto or stereotactic or gamma-knife radiotherapy Morphological increase of one or more lesions of secondary brain metastases on a follow-up MRI Patients affiliated to a social security scheme Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Augustin Gaudemer, MD
Phone
01 40 25 76 13
Email
augustin.gaudemer@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Cécile Henry-Feugeas, MD
Phone
01 40 25 81 52
Email
marie-cecile.henry-feugeas@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Augustin Gaudemer, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Bichat-Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

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Contribution of the CEST Sequence in the Characterization of Radionecrosis of Brain Metastases of Pulmonary Origin

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