- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01672021
Initial Assessment of 18FDG-PET/MRIin Determining the Extent of Systemic Disease in Breast Cancer Patients
Initial Assessment of 18FDG-PET/MRI in Determining the Extent of Systemic Disease in Breast Cancer Patients.
Aperçu de l'étude
Description détaillée
This study is an initial assessment of the ability of 18FDG-PET/MR imaging to detect systemic disease in breast cancer patients as compared with conventional 18FDG-PET/CT.
Rationale: Accurate assessment of the extent systemic disease in breast cancer patients both initially and throughout treatment and surveillance comprises the basis for clinical care including surgical planning, radiation and drug selection. Shortcomings in FDG-PET/CT, a common current method of disease detection and surveillance, include decreased sensitivity in brain, liver and bone and a relatively high radiation dose, which could cause up to 5 new cancers per 1,000 patients (young American women) per scan. Initial studies assessing whole body MRI, a technique which involves no radiation, in the staging of breast cancer patients show promise, but can suffer from decreased ability to detect nodal disease and from detection of false positive lesions. Manual fusion of PET and MRI data in bowel and breast organ systems has been shown to decrease false positive lesions as compared with MRI alone. In the past year, molecular MRI imaging machines which combine PET and MRI imaging have become available for research purposes.
Hypothesis 1: We therefore hypothesize that FDG-PET/MRI will provide concordant or improved lesion detection as compared with FDG-PET/CT in breast cancer patients at a decreased radiation dose.
Hypothesis 2: In addition, the simultaneously acquired PET and MRI data allows for analysis of local tumor characteristics including perfusion, cellularity and glucose metabolism. In the subgroup of patients with an index breast cancer, we hypothesize that these local tumor metrics correlate with number and sites of systemic lesions.
Methods: All newly diagnosed breast cancer patients who are undergoing imaging evaluation for initial extent of disease or disease surveillance at NYU Cancer Center and Bellevue hospital are candidates for study in this protocol. Patients will be invited for follow-up FDG-PET/MRI imaging at any time they are undergoing FDG-PET/CT as part of their clinical care.
Subjects are undergoing FDG-PET/CT at the Cancer Center on 34th St and Lexington Avenue as part of routine care and will be transferred directly to the 38th St. facility by car in a timely manner so that an additional dose of 18-FDG labeled glucose will be unnecessary for the experimental FDG-PET/MRI.
FDG-PET/MRI will be performed and is estimated to 45-60 minutes of scanning time. The patient will then be free to leave the department. Data will be transferred to a workstation and interpreted by two independent radiologists. Size and location of each lesion will be recorded in a confidentiality protected spreadsheet for each component of the scan and the lesion load will be defined by the union of all detected lesions from all three components (DCE-MRI, diffusion-weighted imaging (DWI), FDG-PET). Data will be compared on a per lesion, per organ system and per patient basis with the patient's routine FDG-PET/CT for presence of metastatic disease and size and number of metastatic lesions.
In the case where PET/MRI demonstrates metastatic disease not seen on routine modalities, the referring physician will be alerted. Additional dedicated radiologic studies and biopsy may be recommended and performed at the discretion of the referring physician.
Results: Results of FDG-PET/MRI and FDG-PET/CT findings will be reported in a descriptive format together with related biopsy results and histopathologic correlation. An exact 95% confidence interval will be derived for the true percentage of times the assessment of disease state lesion, per organ system and per patient from FDG-PET/MRI will be concordant with the assessments derived for the same patient using the FDG-PET/CT. In patients with an index breast cancer, Pearson and Spearman rank correlations will be used to characterize the association between local tumor metrics and metastatic burden and location.
Potential benefits: 1. Equal or improved ability to detect metastatic disease in breast cancer patients at a decreased radiation dose. 2. An improved understanding of index tumor metrics help stratify risk for metastatic disease based on the index tumor and enable individually tailored surveillance.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
New York
-
New York, New York, États-Unis, 10016
- NYU School of Medicine
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Any patient with a history or breast cancer undergoing PET/CT either for initial staging or for disease surveillance
-
Exclusion Criteria:
- Pregnant patients and patients with known contraindications for whole body MR imaging (e.g., pacemakers, recent surgery, brain vascular clips, etc.) will be excluded from the study. Patients will be screened with a questionnaire to be sure they have no medical devices that could make the procedure unsafe. Patients with glomerular filtration rate (GFR) < 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study.
Plan d'étude
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 |
---|---|
Autre: PET/MRI
|
TEP/IRM
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Number of metastatic lesions seen on PET/MRI as compared with PET/CT
Délai: 1 year
|
1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Patient stage as imaged by PET/MRI as compared with PET/CT
Délai: 1 year
|
1 year
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Laura Heacock, MD, NYU School of Medicine
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 12-02243
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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 .
Essais cliniques sur Cancer du sein
-
AstraZenecaRecrutementAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian CancerEspagne, États-Unis, Belgique, Royaume-Uni, France, Hongrie, Canada, Corée, République de, Australie
Essais cliniques sur TEP/IRM
-
University of Alabama at BirminghamRecrutement
-
General University Hospital, PragueCharles University, Czech RepublicRecrutementCancer du col de l'utérus | Métastase ganglionnaireTchéquie
-
Abbott Medical DevicesRésilié
-
Centre Hospitalier St AnneAssistance Publique - Hôpitaux de Paris; National Research Agency, France; CENIR... et autres collaborateursInconnueDépression chez les adolescentsFrance
-
Tianjin Third Central HospitalRecrutementDiagnostique la maladie | Cancer hépatocellulaire | Cirrhose du foieChine
-
Universitaire Ziekenhuizen KU LeuvenInconnueRécurrence | Cancer du col de l'utérus | IRM pondérée en diffusionBelgique
-
Centre Georges Francois LeclercActif, ne recrute pas
-
Abbott Medical DevicesComplétéBradycardieL'Autriche
-
Abbott Medical DevicesComplétéLa douleur chronique | Douleur intraitableEspagne, Canada, États-Unis, Finlande, Allemagne, Italie, Suisse
-
Seoul National University Bundang HospitalBayerComplété