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MRI Study of Changes in Blood-Brain/Tumor-Barrier Permeability in Patients With Brain Metastases During and After Radiotherapy

23 maj 2019 uppdaterad av: University of Michigan Rogel Cancer Center
This study aims to assess changes in vascular permeability in the brain tumor, and in the surrounding brain, due to radiation therapy, using Magnetic Resonance Imaging (MRI).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Faktisk)

52

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48109
        • University of Michigan Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patients with brain metastasis receiving radiotherapy.

Beskrivning

Inclusion Criteria:

  • Patients with a histological confirmed malignancy and presence of intraparenchymal brain metastases
  • Patients are treated by WBRT, SRS, or FSRT
  • Age greater than or equal to 18 years
  • A life expectancy of greater than or equal to 8 weeks
  • Karnofsky performance status (an assessment of general well being and ability to do activities of daily living; scale ranges from 0 to 100 where 100 is perfect health) greater than or equal to 60
  • Informed consent with signed study-specific informed consent form

Exclusion Criteria:

  • Major medical or psychiatric illness, which, in the investigator's opinion, will prevent completion of the protocol
  • Patients with lepto-meningeal metastases documented by Magnetic Resonance Imagine (MRI), Computed Tomography (CT), or Cerebrospinal Fluid (CSF) evaluation
  • For patients that will undergo Whole Brain Radiation Therapy (WBRT), previous WBRT is not allowed. Patients who have had brain metastases managed by Stereotactic Radiosurgery (SRS), Fractionated Stereotactic Radiation Therapy (FSRT), or surgery are eligible
  • For patients that will undergo Stereotactic Radiosurgery (SRS), previous Whole Brain Radiation Therapy (WBRT) within 5 months prior to study entry is not allowed. Prior Stereotactic Radiosurgery (SRS), Fractionated Stereotactic Radiation Therapy (FSRT), or surgery is allowed if current treatment will be for a lesion(s) not previously treated.
  • For patients that will undergo Fractionated Stereotactic Radiation Therapy (FSRT), previous Whole Brain Radiation Therapy (WBRT) within 5 months prior to study entry is not allowed. Prior Stereotactic Radiosurgery (SRS), Fractionated Stereotactic Radiation Therapy (FSRT), or surgery is allowed if current treatment will be for a lesion(s) not previously treated.
  • Patients unable to undergo or tolerate MRI scans (presence of cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, etc).
  • Patients should have no contraindications to having a contrast enhanced Magnetic Resonance Imaging (MRI) scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the University of Michigan.
  • Women who are pregnant are excluded.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Stereotactic Radiosurgery (SRS)

Patients with brain metastases receiving single fraction Stereotactic Radiosurgery (SRS). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment.

MRI scans will be performed approximately 1-2 weeks prior to SRS, and 1-2 weeks and 1 month after SRS. The MRI scan will include a routine clinical MRI series.
Strålning: Single Fraction Stereotactic Radiosurgery (SRS)
Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.
Enhet: Magnetic Resonance Imaging (MRI) Assessments
MRI scans will include a routine clinical MRI series.
Whole Brain Radiation Therapy

Patients with brain metastases receiving fractionated (spread out over time) Whole Brain Radiation Therapy (WBRT). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment.

MRI scans will be performed approximately 1-2 weeks prior to RT, at the end of RT and 1 month after RT. The MRI scan will include a routine clinical MRI series.
Enhet: Magnetic Resonance Imaging (MRI) Assessments
MRI scans will include a routine clinical MRI series.
Strålning: Fractionated Whole Brain Radiation Therapy (WBRT)
Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.
Stereotactic Radiation Therapy

Patients with brain metastases receiving fractionated (spread out over time) Stereotactic Radiation Therapy (FSRT). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment.

MRI scans will be performed approximately 1-2 weeks prior to FSRT, during the last week of RT but before the last fraction and 1 month after RT. The MRI scan will include a routine clinical MRI series.
Enhet: Magnetic Resonance Imaging (MRI) Assessments
MRI scans will include a routine clinical MRI series.
Strålning: Fractionated Stereotactic Radiation Therapy (FSRT)
Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of the Gross Tumor Volume With a BTB Opening of Ktrans > 0.005 Min-1
Tidsram: Pre-Treatment, 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment
Fifty metastatic lesions from 21 patients received WBRT and 14 lesions from 9 patients treated by SRS were analyzed. Permeability of BTB (Blood-Tumor-Barrier) was quantified by the transfer constant, Ktrans, derived from dynamic contrast enhanced (DCE)-MRI that were acquired pre, 1-2 weeks after starting, and 1-month post-radiotherapy. A percentage volume of the BM with Ktrans >0.005 min-1 (%Vall) was used to evaluate the extent of BTB opening pre-RT and subsequent changes after receiving radiotherapy. The 50 lesions, from the 21 patients treated with Whole Brain Radiation Therapy, were divided into two subgroups: low-leaky (%Vall <50%) and high-leaky, based upon pre-RT measurements. Of the 50 lesions, 7 were classified as low leaky and 43 were classified as high leaky. All 14 SRS lesions were classified as high leaky.
Pre-Treatment, 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment
Change in Magnitude and Regional Variability of Blood Tumor Barrier (BTB)/Blood Brain Barrier (BBB) Permeability (Per Minute) in Tumor, Tumor Margin, Normal Brain and Brain Metastases
Tidsram: Week -2 to -1, End of Treatment (WBRT), 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment
An in-house program, based on a general kinetic model, along with an MRI contrast agent, Gadopentetic Acid (Gd-DTPA), will be used to estimate vascular permeability (per minute).
Week -2 to -1, End of Treatment (WBRT), 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Mean K^Trans During and After Radiation Therapy
Tidsram: Pre-treatment and 1 Month Post Treatment
Effect of radiation dose on vascular permeability (per minute) of the Blood Tumor Barrier (BTB)/Blood Brain Barrier (BBB). Permeability of BTB was quantified by Ktrans.
Pre-treatment and 1 Month Post Treatment

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Michigan Rogel Cancer Center

Utredare

  • Huvudutredare: Yue Cao, Ph.D., University of Michigan Rogel Cancer Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2005

Primärt slutförande (Faktisk)

1 maj 2014

Avslutad studie (Faktisk)

1 december 2014

Studieregistreringsdatum

Först inskickad

13 november 2013

Först inskickad som uppfyllde QC-kriterierna

7 januari 2014

Första postat (Uppskatta)

9 januari 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 juli 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 maj 2019

Senast verifierad

1 maj 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • UMCC 2005.003
  • HUM00043426 (Annan identifierare: University of Michigan)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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