Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-25 @ 3:13 AM
NCT ID:
NCT01308905
Eligibility Criteria:
Inclusion Criteria:
* All patients with neuroblastoma or suspected neuroblastoma seen at Children's Hospital of Michigan (CHM). Patients need to be 2 years or older to be eligible for the initial study
* Patients must be 1 day to 21 years old, there is no gender limit.
* Diagnosis: All patients with neuroblastoma or suspected neuroblastoma, including newly diagnosed and relapsed patients, are eligible for Objective 1. To be eligible for Objective 2, patients must have a diagnosis of neuroblastoma verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites, and have measurable disease after the initial surgery
* Female adolescent patients must have a negative pregnancy test within 14 days of first imaging and should not be pregnant
* Patients must be able to lie still for the tests, or have no contraindication for sedation
* Patients or their legal guardian must sign an informed consent indicating that they are aware of the investigational nature of this study
* A total number of 40-50 patients will be included in the study
Exclusion Criteria:
* Patients who do not have a histology diagnosis of neuroblastoma are not eligible for the study
* Patients whose definite diagnosis after surgery is not consistent with the diagnosis of neuroblastoma will be included in the Objective 1 but excluded for Objective 2.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
21 Years
Study:
NCT01308905
Study Brief:
Protocol Section:
NCT01308905