- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00001574
A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors
Brain tumors represent the most common solid tumor of childhood. Treatment generally entails surgery and radiation, but local recurrence is frequent. Chemotherapy is often used in an adjuvant setting, to delay radiation therapy or for resistant disease. Children with brain tumors are generally followed by imaging studies, such as CT or MRI. Difficulty arises in trying to distinguish tumor regrowth from treatment related edema, necrosis or radiation injury. Proton Nuclear Magnetic Resonance Spectroscopic (NMRS) Imaging is a non-invasive method of detecting and measuring cellular metabolites in vivo. NMRS imaging complements routine MRI by giving chemical information in conjunction with spatial information obtained by MRI.
This study will be conducted to determine NMRS imaging patterns before, during and after chemotherapy in pediatric patients with primary or metastatic brain tumors in an attempt to identify and characterize specific patterns of metabolites related to tumor regrowth, tumor response to therapy, edema or necrosis.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
Background:
- Brain tumors represent the most common solid tumor of childhood. Treatment generally includes surgery and radiation, but recurrences are frequent, particularly for high-grade lesions.
- Chemotherapy is often used in an adjuvant setting, to delay radiation therapy or for resistant disease.
- Children with brain tumors are generally followed by imaging studies, such as CT or MRI.
- Difficulty arises in trying to distinguish tumor regrowth from treatment related edema, necrosis or radiation injury.
- Proton Nuclear Magnetic Resonance Spectroscopic (NMRS) Imaging is a non-invasive method of detecting and measuring cellular metabolites in vivo.
Objective:
- To determine NMRS imaging patterns before, during and after chemotherapy in pediatric patients with primary or metastatic brain tumors
- To identify and characterize specific patterns of metabolites related to tumor regrowth, tumor response to therapy, edema or necrosis.
Eligibility:
- Age less than or equal to 21 years.
- Patients entered on this trial will also be entered on one of the Branch s primary brain tumor treatment trials.
- Histologically confirmed primary or metastatic brain tumor. Patients with a brainstem glioma or optic pathway gliomas are not required to have a histologic diagnosis.
- Measurable or evaluable tumor at the time of study entry.
Design:
- This is intended to be a pilot study to define metabolite patterns associated with tumor growth, tumor edema and tumor necrosis as seen on standard MRI; and determine the feasibility of using metabolite patterns to predict response to therapy in pediatric patients with brain tumors.
- Contalateral spectroscopic analysis of normal appearing brain will also be performed when feasible.
- Analysis of results will be stratified according to type of tumor, and prior history of radiation therapy or surgery.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Maryland
-
Bethesda, Maryland, Yhdysvallat, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
- INCLUSION CRITERIA:
Age less than or equal to 21 years.
Patients entered on this trial will also be entered on one of the Pediatric Oncology Branch's primary treatment trials (e.g., phenylacetate, phenylbutyrate, SU-101) or on the Natural History or Standard Therapy protocols. The patient's management will be determined by the primary treatment protocol.
Histology confirmed primary or metastatic brain tumor. Patients with a brainstem glioma are not required to have previously had a histologic diagnosis.
Measurable or evaluable tumor at the time of study entry.
Durable Power of Attorney (DPA): A DPA is required of all patients 18 - 21 years of age.
All patients or their legal guardians (if the patient is less than 18 years of age) must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study. When appropriate the minor patient will give verbal assent.
EXCLUSION CRITERIA:
Pregnant women.
Any patient who is unable (either because of physical or psychological factors) to undergo imaging studies and who is not an anesthesia candidate.
Any patient with a metallic implant, including cardiac pacemakers, neural pacemakers, shrapnel, cochlear implants or ferrous surgical clips.
Any patient with a history of a severe reaction to Gadolinium or other contrast agents.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
To define specific patterns of metabolises using long-echo time multislice proton nuclear magnetic resonance spectroscopic imaging in pediatric patients with brain tumors.
Aikaikkuna: at time of disease evaluation
|
in vivo measurements of tissue metabolites (NAA, Cho,Cr, Lac) and what they reflect
|
at time of disease evaluation
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Distinguish spectroscopic patterns associated with tumor progression, necrosis and edema
Aikaikkuna: at time of disease evaluation
|
measurements and differences of signal intensity of peaks obtained for tissue metabolites (NAA, Cho, Cr, Lac)
|
at time of disease evaluation
|
Determine if early metabolic changes are predictive of response
Aikaikkuna: at time of disease evaluation
|
Contalateral spectroscopic analysis results, stratified according to type of tumor, history of radiation therapy or surgery
|
at time of disease evaluation
|
Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Castillo M, Kwock L, Mukherji SK. Clinical applications of proton MR spectroscopy. AJNR Am J Neuroradiol. 1996 Jan;17(1):1-15. No abstract available.
- Sutton LN, Wang Z, Gusnard D, Lange B, Perilongo G, Bogdan AR, Detre JA, Rorke L, Zimmerman RA. Proton magnetic resonance spectroscopy of pediatric brain tumors. Neurosurgery. 1992 Aug;31(2):195-202. doi: 10.1227/00006123-199208000-00004.
- Duyn JH, Gillen J, Sobering G, van Zijl PC, Moonen CT. Multisection proton MR spectroscopic imaging of the brain. Radiology. 1993 Jul;188(1):277-82. doi: 10.1148/radiology.188.1.8511313.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 970093
- 97-C-0093
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Aivosyöpä
-
Assistance Publique Hopitaux De MarseilleTuntematon
-
University of PadovaEi vielä rekrytointiaTarget Controlled Infuusio | Sufentaniili | Anestesia Brain MonitorItalia
-
University of MichiganLopetettuMuutokset Brain-verkkoyhteyksissäYhdysvallat
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)ValmisLymfaödeema | Perioperatiiviset/postoperatiiviset komplikaatiot | Vaiheen II Vulvar Cancer AJCC v7 | Vaihe IIIA Vulvar Cancer AJCC v7 | Vaihe IIIB Vulvar Cancer AJCC v7 | Vaihe IIIC Vulvar Cancer AJCC v7 | Stage IVA Vulvar Cancer AJCC v7 | Vaihe IA Vulvar Cancer AJCC v7 | Vaihe IB Vulvar Cancer AJCC v7 | Vaihe...Yhdysvallat
-
Fore BiotherapeuticsRekrytointiCancer sisältää BRAF-muutoksiaYhdysvallat, Saksa, Espanja, Yhdistynyt kuningaskunta, Ranska, Korean tasavalta, Italia, Ruotsi, Kanada
-
University of Texas Southwestern Medical CenterRekrytointiBrain MassYhdysvallat
-
Assiut UniversityValmisBrain Voxel -pohjainen morfometria ManiassaEgypti
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Aktiivinen, ei rekrytointiVaiheen III vulvar Cancer AJCC v7 | Vaihe IIIA Vulvar Cancer AJCC v7 | Vaihe IIIB Vulvar Cancer AJCC v7 | Vaihe IIIC Vulvar Cancer AJCC v7 | Epäsuoran levyepiteelisyöpä | Stage IVA Vulvar Cancer AJCC v7Yhdysvallat
-
Samsung Medical CenterValmisHER2-positiivinen Refractory Advanced CancerKorean tasavalta
-
University of Alabama at BirminghamRekrytointiHypertensio | BMI | Harjoittele | Brain Care -pisteetYhdysvallat