Whole-Body MRI in the Evaluation of Pediatric Malignancies
Collecte de données
Lymphome de Burkitt+27
+ Infections par virus ADN
+ Maladies hématologiques et lymphatiques
Étude diagnostique
Résumé
Date de début de l'étude : 1 octobre 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Compare non-inferior diagnostic performance of whole-body MRI (i.e., combination of turbo short-tau inversion-recovery (STIR) and out-of-phase imaging) vs conventional imaging (i.e., the combination of chest CT scan, scintigraphy \[bone, gallium, meta-iodobenzylguanidine (MIBG), or optional fludeoxyglucose F 18 positron emission tomography (FDG-PET)\] and abdominal/pelvic CT scan/MRI as indicated) for detecting distant metastases for use in staging common tumors in pediatric patients. Secondary * Determine the incremental benefit of adding out-of-phase T1-weighted gradient-recalled echo imaging to turbo STIR for detecting distant disease in these patients. * Determine, preliminarily, the relative accuracies of FDG-PET, whole-body MRI, and a combination of FDG-PET and whole-body MRI in detecting stage IV disease in these patients. * Determine the effects of multiple factors, including cancer type, site of primary tumor, and patient age, on diagnostic accuracy of whole-body MRI in these patients. * Determine the interobserver variability associated with interpreting whole-body MRI exams for detecting distant metastases in these patients. OUTLINE: This is a multicenter study. Patients undergo conventional MRI, CT scan, and/or scintigraphy (e.g., bone, meta-iodobenzylguanidine \[MIBG\], or gallium) and experimental whole-body MRI sequences. Patients may optionally undergo fludeoxyglucose F18 positron emission tomography (FDG-PET). Patients with a lesion (or lesions) detected on whole-body MRI or FDG-PET at initial staging that are not confirmed by biopsy or other conventional imaging studies at staging repeat standard imaging at 3- to 6-month follow-up. Patients with an abnormality that is considered highly suspicious for a metastasis or when biopsy proof of that metastasis is obtained receive treatment at the discretion of the treating physician. Patients are followed annually for 3 years. PROJECTED ACCRUAL: A total of 226 patients (45 with neuroblastoma, 54 with rhabdomyosarcoma, 27 with other sarcoma, and 100 with lymphoma) will be accrued for this study within 1 year.
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.226 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Diagnostic
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.Jusqu'à 21 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: * Confirmed diagnosis OR newly diagnosed mass strongly suspected to represent 1 of the following: * Rhabdomyosarcoma * Ewing's sarcoma family of tumors * Neuroblastoma * Hodgkin's lymphoma * Non-Hodgkin's lymphoma * All imaging examinations (e.g., CT scan, MRI, or scintigraphy) must be performed within 14 days of each other and within 2 months of any diagnostic or operative procedure * Whole body MRI and positron emission tomography (PET) scanning (if PET scan is being done) must be done before treatment * Prior CT scan, conventional MRI, bone scintigraphy, gallium scintigraphy, or meta-iodobenzylguanidine (MIBG) scintigraphy performed at outside institutions allowed provided the same technical standards specified in this study were practiced * Bone scintigraphy required for patients with neuroblastoma, rhabdomyosarcoma, or other sarcomas * Gallium scintigraphy not required in lymphoma patients if PET scan is performed * No CNS primary tumor PATIENT CHARACTERISTICS: Age * 21 and under Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * No active cardiac pacemakers Other * Not pregnant or nursing * No prior malignancy * No uncontrolled diabetes mellitus (for patients undergoing optional PET) * Patients with controlled diabetes mellitus must have a fasting blood glucose no greater than 200 mg/dL * No contraindications to MRI or CT scan (e.g., intracranial vascular clips) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Prior biopsy or surgery allowed provided no more than 2 months has passed since the procedure
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 21 sites
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, United StatesOuvrir UCSF Helen Diller Family Comprehensive Cancer Center dans Google MapsChildren's Hospital Center for Cancer and Blood Disorders
Aurora, United StatesNemours Children's Clinic
Jacksonville, United StatesUniversity of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, United States