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Pilot Study to Determine the Utility of [18F] 3'-Deoxy-3'-Fluorothymidine- Positron Emission Tomography in Monitoring Patient Response to Chemotherapy in Neuroblastoma


Phase 1
N/A
21 Years
Open (Enrolling)
Both
Neuroblastoma

Thank you

Trial Information

Pilot Study to Determine the Utility of [18F] 3'-Deoxy-3'-Fluorothymidine- Positron Emission Tomography in Monitoring Patient Response to Chemotherapy in Neuroblastoma


The purpose of this research study is to observe the changes within the tumor cells which
may improve the understanding of how tumors grow and how they respond to various treatments.
These changes will be compared with results of the physical examination and scans (CT and
MRI) that are done as part of clinical care. Images will be made showing the distribution
throughout the body of substances containing a small amount of radioactive material. This
procedure is called a PET scan. The radioactive substances (tracer compound) in this study
are [F-18] FLT.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To determine whether 18F-FLT-PET is a sensitive tool to image neuroblastoma.

Outcome Time Frame:

1st PET - At diagnosis

Safety Issue:

No

Principal Investigator

Anthony F. Shields, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Karmanos Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

WSU 2009-031

NCT ID:

NCT01308905

Start Date:

February 2011

Completion Date:

February 2016

Related Keywords:

  • Neuroblastoma
  • Neuroblastoma
  • Neuroblastoma

Name

Location

Children's Hospital of Michigan Detroit, Michigan  48201