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MRI Scans in Evaluating the Effects of Radiation Therapy and Chemotherapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Glioma

28 avril 2020 mis à jour par: Elizabeth R. Gerstner, MD, Massachusetts General Hospital

Quantitative Assessment of the Early and Late Effects of Radiation and Chemotherapy on Glioblastoma Using Multiple MRI Techniques

RATIONALE: Diagnostic procedures, such as MRI, may help in learning how well radiation therapy and chemotherapy work in killing tumor cells and allow doctors to plan better treatment.

PURPOSE: This clinical trial is studying MRI scans to see how well they evaluate the effects of radiation therapy and chemotherapy in patients with newly diagnosed glioblastoma multiforme or anaplastic glioma.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

OBJECTIVES:

Primary

  • To quantitatively compare the relative cerebral blood volume/flow, mean transit time, and mean vessel diameter as measured by perfusion-weighted MRI before, during, and after chemoradiotherapy in patients with newly diagnosed glioblastoma multiforme.
  • To measure the permeability-surface area product on a voxel-by-voxel basis before, during, and after chemoradiotherapy in these patients.
  • To measure the full water self-diffusion tensor on a voxel-by-voxel basis before, during, and after chemoradiotherapy in these patients.
  • To compare the tensor fractional anisotropy before, during, and after chemoradiotherapy in these patients.
  • To compare the relative regional concentrations of choline, N-acetyl-asparate, and myoinositol as measured by magnetic resonance spectroscopy before, during, and after chemoradiotherapy to interrogate cell membrane turnover, neuronal integrity, and glial reactions.
  • To test the affects of a short period of 100% oxygen inhalation on imaging of tumor and surrounding tissue regions of interest, specifically cerebral blood volume changes in each area as compared to room air.

Secondary

  • To collect blood and urine samples for correlation analysis between imaging changes, molecular markers (including genetic markers), and clinical outcome of glioblastoma multiforme (phenotypic information).
  • To correlate blood and urine biomarkers and blood genetic markers with tumor expression of these markers.

OUTLINE: Patients undergo radiotherapy once daily 5 days a week for 6 weeks. Patients also receive oral temozolomide once daily 7 days a week during radiotherapy. After completion of chemoradiotherapy, patients receive oral temozolomide once daily for 5 days. Treatment with temozolomide repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo MRI, including perfusion- and diffusion-weighted MRI, diffusion tensor imaging, and magnetic resonance spectroscopy prior to initiation of chemoradiotherapy, once weekly during chemoradiotherapy, and then monthly until tumor progression or until completion of 6 courses of post chemoradiotherapy.

After completion of study treatment, patients are followed annually.

Type d'étude

Interventionnel

Inscription (Réel)

15

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02114
        • Massachusetts General Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

DISEASE CHARACTERISTICS:

  • Newly diagnosed anaplastic glioma (WHO grade III) or glioblastoma multiforme (WHO grade IV)

  • Measurable disease

    • Residual tumor size after surgery ≥ 1 cm in one dimension
  • Planning to undergo standard chemoradiotherapy with temozolomide

PATIENT CHARACTERISTICS:

  • Glomerular filtration rate ≥ 60 mL/min
  • Mini Mental Status Exam score > 15
  • Sufficiently competent to give informed consent
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 2 months after completion of study treatment

  • No contraindication to MRI or to use of the contrast agent gadolinium, including any of the following:

    • Claustrophobia
    • Metallic objects or implanted medical devices (e.g., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)
    • Sickle cell disease
    • Renal failure
    • High risk for kidney disease (e.g., age > 60 years, diabetes, or history of systemic lupus erythematosus or multiple myeloma)
  • No known history of chronic obstructive pulmonary disease or emphysema
  • No other co-existing condition that, in the judgement of the investigator, may increase risk to the patient

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Non-VEGF investigational agent allowed
  • No concurrent chemotherapy (other than temozolomide)
  • No concurrent electron, proton, particle, or implant radiotherapy
  • No concurrent stereotactic radiosurgery
  • No concurrent anti-VEGF anti-tumor agents

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Temozolomide and Radiation Therapy
Médicament: temozolomide
Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.
Autre: Imaging biomarker analysis
MRI
Radiation: Photon Radiation Therapy
Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy
Délai: Baseline, weekly during treatment, monthly following treatment for up to six months

Relative cerebral blood volume (rCBV) is the blood volume in the region of interest (ROI) divided by the blood volume in the symmetrical region on the other side of the normal brain (control region). CBV was assessed using spin-echo post-contrast T1-weighted images. Multiple images were used to assess each participant at every time-point and the median value for each participant was calculated by time-point. The data presented represent the average of those median values at each time-point. The baseline value was measured twice (representing baseline 1 and 2) to make sure that the value was reproducible and to account for any variation attributable to measurement variation.

CRT: Chemoradiotherapy Cx: The cycle number TMZ: temozolomide
Baseline, weekly during treatment, monthly following treatment for up to six months
Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy
Délai: Baseline, weekly during treatment, monthly following treatment for up to six months

Relative cerebral blood flow (rCBF) is the blood flow rate (the volume of blood passing through the specified are over a specified period of time) in the region of interest (ROI) divided by the blood flow rate in the symmetrical region on the other side of the normal brain (control region). CBF was assessed using spin-echo post-contrast T1-weighted images. CBF was assessed using spin-echo post-contrast T1-weighted images. Multiple images were used to assess each participant at every time-point and the median value for each participant was calculated by time-point. The data presented represent the average of those median values at each time-point. The baseline value was measured twice (representing baseline 1 and 2) to make sure that the value was reproducible and to account for any variation attributable to measurement variation.

CRT: Chemoradiotherapy Cx: The cycle number TMZ: temozolomide
Baseline, weekly during treatment, monthly following treatment for up to six months
Vessel Diameter as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy
Délai: Baseline, weekly during treatment, monthly following treatment for up to six months
Baseline, weekly during treatment, monthly following treatment for up to six months
Mean Transit Time as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy
Délai: Baseline, weekly during treatment, monthly following treatment for up to six months
Mean transit time (MTT) corresponds to the average time, in seconds, that red blood cells spend within a determinate volume of capillary circulation.
Baseline, weekly during treatment, monthly following treatment for up to six months
Permeability-surface Area Product Before, During, and After Chemoradiotherapy
Délai: Baseline, weekly during treatment, monthly following treatment for up to six months

Permeability-surface Area Product (Ktrans). Ktrans reflects the efflux rate of contrast from blood plasma into the tissue extravascular extracellular space (EES). Ktrans was assessed using post-contrast T1-weighted images. Multiple images were used to assess each participant at every time-point and the median value for each participant was calculated by time-point. The data presented represent the average of those median values at each time-point.

CRT: Chemoradiotherapy Cx: The cycle number TMZ: temozolomide
Baseline, weekly during treatment, monthly following treatment for up to six months
Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy
Délai: Baseline, weekly during treatment, monthly following treatment for up to six months

Apparent diffusion coefficient (ADC) is a measure of the magnitude of diffusion (of water molecules) within tissue. ADC was assessed using post-contrast T1-weighted images. Multiple images were used to assess each participant at every time-point and the median value for each participant was calculated by time-point. The data presented represent the average of those median values at each time-point.

CRT: Chemoradiotherapy Cx: The cycle number TMZ: temozolomide
Baseline, weekly during treatment, monthly following treatment for up to six months
Tensor Fractional Anisotropy Before, During, and After Chemoradiotherapy
Délai: Baseline, weekly during treatment, monthly following treatment for up to six months
Fractional anisotropy (FA) is a measure of the directionality of the molecular motion of water.
Baseline, weekly during treatment, monthly following treatment for up to six months
Relative Regional Concentrations of Choline, N-acetyl-asparate, and Myoinositol as Measured by Magnetic Resonance Spectroscopy Before, During, and After Chemoradiotherapy to Interrogate Cell Membrane Turnover, Neuronal Integrity, and Glial Reactions
Délai: Baseline, weekly during treatment, monthly following treatment for up to six months
Baseline, weekly during treatment, monthly following treatment for up to six months
Affects of a Short Period of 100% Oxygen Inhalation on Imaging of Tumor and Surrounding Tissue Regions of Interest, Specifically Cerebral Blood Volume Changes in Each Area as Compared to Room Air
Délai: Baseline, weekly during treatment, monthly following treatment for up to six months
Baseline, weekly during treatment, monthly following treatment for up to six months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Massachusetts General Hospital

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Elizabeth Gerstner, MD, Massachusetts General Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juillet 2008

Achèvement primaire (Réel)

1 février 2012

Achèvement de l'étude (Réel)

1 février 2012

Dates d'inscription aux études

Première soumission

18 septembre 2008

Première soumission répondant aux critères de contrôle qualité

18 septembre 2008

Première publication (Estimation)

19 septembre 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 mai 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 avril 2020

Dernière vérification

1 avril 2020

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 07-292

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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