Monitor Response to Treatment in Neuroblastoma Using 3&Apos;-Deoxy-3&Apos;-Fluorothymidine- Positron Emission Tomography (FLT-PET)

NCT01308905 | Unknown DMC

• 1 other identifier: WSU 2009-031
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to gain knowledge about how to best diagnose and treat tumors, how tumors affect normal tissue and how treatment of tumors with radiation therapy and chemotherapy affect tumors.

Conditions

Neuroblastoma

Keywords

Neuroblastoma

Outcome Measures

Primary Outcomes (1)

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

  1st PET - At diagnosis

Secondary Outcomes (3)

• To evaluate the utility of FLT-PET in early assessment of patient response to treatment.

  1st PET - At diagnosis

• To evaluate the utility of FLT-PET in early assessment of patient response to

  2nd PET - Approx. 3 wks (end of 1st cycle)

• To evaluate the utility of FLT-PET in early assessment of patient response to treatment.

  3rd PET: 6-15 wks (Prior to surgery)

Study Arms (1)

FLT-PET

EXPERIMENTAL

Patients will be managed per COG protocol ANBL00B1 (low risk, LR), ANBL0521 (intermediate risk, IR), ANBL0531 (high risk, HR) or other future neuroblastoma studies according to their risk group (risk assignment, treatment schema and protocols are available in COG website). The following is a brief description of the treatment. 1. Low risk patients: observation only. 2. Intermediate risk patients: chemotherapy stratified according to risk sub-groups followed by surgical resection. 3. High risk patients: 6 courses of induction chemotherapy, surgical resection and high dose chemotherapy with autologous stem cell transplant (SCT), involved field radiation and 6 months of Isotrenitoin. PET scan will be conducted at diagnosis, at the end of the first cycle of treatment and prior to the surgical procedure (resection).

Device: FLT-PET

Interventions

FLT-PET DEVICE

PET scan will be conducted at diagnosis, at the end of the first cycle of treatment and prior to the surgical procedure (resection).

FLT-PET

Eligibility Criteria

• Age: 1 Day - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• Children's Hospital of Michigan: collaborator

Study Sites (1)

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Conditions

Neuroblastoma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Anthony F. Shields, M.D., Ph.D.

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhihong J Wang, M.D., Ph.D.

CONTACT

(313) 966-7772; jwang2@wayne.edu

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

CONTACT

(313) 576-8735; shieldsa@karmanos.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: PET scans will be performed to show the distribution throughout the body of substances containing a small amount of radioactive material.

Study Record Dates

• First Submitted: February 22, 2011
• First Posted: March 4, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 6, 2017

Record last verified: 2017-04

Locations

US (1)