- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01898533
Feasibility of Blood Oxygenation Level-Dependent Contrast (BOLD) Breast MRI Induced by Breath- Holding (BOLD)
A Pilot Study of the Feasibility of Blood Oxygenation Level-Dependent Contrast ( BOLD) Breast MRI Induced by Breath- Holding
In this study, investigators intend to measure changes in BOLD contrast in the breast induced by breath-holding for subjects receiving radiation therapy to the breast. This study will provide the preliminary data and experience needed to successfully apply BOLD to quantify changes in oxygenation and blood flow of breast and tumor for a larger cohort of breast radiotherapy patients. The current study has the following objectives:
- To determine the feasibility of BOLD contrast MRI of the breast, induced by breath-hold.
- To measure the change in BOLD contrast of the breast and / or chest wall tissue for females undergoing radiotherapy
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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North Carolina
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Durham, North Carolina, États-Unis, 27710
- Duke University Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria: • Post-operative patients who are undergoing planning for future whole breast radiation therapy may be included in the study
- Female
- Age ≥18
- Negative serum pregnancy test for women of child bearing potential
- Signed study-specific informed consent
Exclusion Criteria:
- Unable to perform breath-holding of adequate duration.
- Unable to lie prone for approximately one hour during the study procedure
- Breast implants
- Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- MRI compatible surgical clips, shrapnel, etc.
- Positive serum pregnancy test
- Mastectomy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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The change in BOLD contrast of the breasts and / or chest wall tissue will be measured by comparing breath hold sequences to normal breathing.
Délai: During MRI approx 1 hour
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Subjects will be evaluated holding their breath and during normal breathing.
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During MRI approx 1 hour
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Feasibility as measured by a BOLD contrast signal in at least 30% of subjects
Délai: During MRI approx one hour
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The imaging technique will be considered feasible if for any of the proposed imaging sequences, breath-holding induces a measurable (≥3× standard deviation of background) BOLD contrast signal in at least 30% of the subjects.
Contrast will be measured by comparing breath hold sequences to normal breathing.
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During MRI approx one hour
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Rachel Blitzblau, MD PhD, Duke University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Pro00046072
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