An NCI-Sponsored Exploratory Study For Determining Optimum Timing For The Imaging Of Intravenous Superparamagnetic Particle Ferumoxytol (Code7228) For The Differentiation of Metastatic and Non Metastatic Lymph Nodes in Patients With Known Primary Cancer Scheduled For Possible Surgical Lymph Node Biopsy/Dissection
Collecte de données
Maladies génito-urinaires+10
+ Maladies Génitales
+ Maladies du sein
Résumé
Date de début de l'étude : 1 septembre 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Determine the range of optimal timing for magnetic resonance imaging of lymph nodes after administration of ferumoxytol, in terms of assessing signal intensity using pre-defined pulse sequences in regions of interest and visual criteria, in patients with primary prostate or breast cancer who are scheduled to undergo surgical lymph node dissection or sampling. Secondary * Correlate MRI signal intensity with histological findings in patients undergoing this procedure. OUTLINE: This is an open-label, pilot study. Patients undergo a baseline MRI. Within 24 hours after the baseline MRI, patients receive ferumoxytol IV over 10-15 seconds (or over 1 hour). Patients then undergo MRI immediately after ferumoxytol administration (at the discretion of the principal investigator) and then at 24-28 hours. Patients are followed at 2 weeks. PROJECTED ACCRUAL: A total of 10-14 patients (6-8 with prostate cancer and 4-6 with breast cancer) will be accrued for this study.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.14 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: * Histologically confirmed primary prostate or breast cancer * Suspected lymph node metastatic disease by standard MRI or CT scan * Scheduled for surgical lymph node dissection or sampling * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Not specified Menopausal status * Not specified Performance status * Not specified Life expectancy * Not specified Hematopoietic * No prior ferritin \> 800 ng/mL * No prior transferrin saturation \> 60% * No history of iron overload or hemachromatosis * Patients with a clinical history of suspected iron overload or hemachromatosis must have normal serum iron, ferritin, and transferrin saturation Hepatic * Bilirubin ≤ 2 times upper limit of normal (ULN) * SGOT ≤ 2 times ULN Renal * Not specified Other * No requirement for monitored anesthesia during MRI * No known allergic or hypersensitivity reaction to any of the following parenterally-administered preparations: * Iron * Dextran * Iron dextran * Iron polysaccharide * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for at least 1 month before and during study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No prior therapy for metastatic disease
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site