- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02031237
MRI Study of Changes in Blood-Brain/Tumor-Barrier Permeability in Patients With Brain Metastases During and After Radiotherapy
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Michigan
-
Ann Arbor, Michigan, Stati Uniti, 48109
- University of Michigan Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
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. |
Intervention will not be assigned by the investigator.
Treatment determination will be made prior to study enrollment.
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. |
MRI scans will include a routine clinical MRI series.
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. |
MRI scans will include a routine clinical MRI series.
Intervention will not be assigned by the investigator.
Treatment determination will be made prior to study enrollment.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Percentage of the Gross Tumor Volume With a BTB Opening of Ktrans > 0.005 Min-1
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in Mean K^Trans During and After Radiation Therapy
Lasso di tempo: 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
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Yue Cao, Ph.D., University of Michigan Rogel Cancer Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UMCC 2005.003
- HUM00043426 (Altro identificatore: University of Michigan)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Metastasi cerebrali
-
University of PadovaCompletatoPropofol | Anestesia Brain MonitoringItalia
-
University of PadovaCompletato
-
University of PadovaReclutamentoAnestesia Brain MonitoringItalia
-
University of PadovaCompletato
-
University of PadovaCompletato
-
University of PadovaCompletatoPropofol | Anestesia Brain MonitoringItalia
-
University of PadovaCompletatoLidocaina | Anestesia Brain MonitoringItalia
-
University of Dublin, Trinity CollegeSconosciutoBrain Health Atleti d'élite in pensione
-
Assiut UniversityCompletatoMorfometria basata su Brain Voxel in ManiaEgitto