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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Barbara Ann Karmanos Cancer Institute
Sponsor:
Collaborators:
Children's Hospital of Michigan
Information provided by (Responsible Party):
Zhihong Wang, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT01308905
First received: February 22, 2011
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Neuroblastoma
Device: FLT-PET
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study to Determine the Utility of [18F] 3'-Deoxy-3'-Fluorothymidine- Positron Emission Tomography in Monitoring Patient Response to Chemotherapy in Neuroblastoma

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • To determine whether 18F-FLT-PET is a sensitive tool to image neuroblastoma. [ Time Frame: 1st PET - At diagnosis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the utility of FLT-PET in early assessment of patient response to treatment. [ Time Frame: 1st PET - At diagnosis ] [ Designated as safety issue: No ]
  • To evaluate the utility of FLT-PET in early assessment of patient response to [ Time Frame: 2nd PET - Approx. 3 wks (end of 1st cycle) ] [ Designated as safety issue: No ]
  • To evaluate the utility of FLT-PET in early assessment of patient response to treatment. [ Time Frame: 3rd PET: 6-15 wks (Prior to surgery) ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FLT-PET

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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308905

Contacts
Contact: Zhihong J Wang, M.D., Ph.D. (313) 966-7772 jwang2@wayne.edu
Contact: Anthony F Shields, M.D., Ph.D (313) 576-8735 shieldsa@karmanos.org

Locations
United States, Michigan
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
Contact: Zhihong J Wang, M.D., Ph.D.    313-577-5515      
Contact: Anthony F Shields, M.D., Ph.D.    (313) 576-8735      
Sub-Investigator: Majid Khalaf, M.D.         
Sub-Investigator: Yaddanapudi Ravindranath, M.D.         
Sub-Investigator: Diane Chugani, Ph.D.         
Sub-Investigator: Thomas Mangner, Ph.D.         
Sub-Investigator: Otto Muzik, Ph.D.         
Sub-Investigator: Jeffrey Taub, M.D.         
Sub-Investigator: Sureyya Savasan, M.D.         
Sub-Investigator: Roland Chu, M.D.         
Sub-Investigator: Kanta Bhambhani, M.D.         
Sub-Investigator: Anthony F Shields, M.D., Ph.D.         
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Children's Hospital of Michigan
Investigators
Principal Investigator: Anthony F. Shields, M.D., Ph.D. Karmanos Cancer Institute
  More Information

No publications provided

Responsible Party: Zhihong Wang, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01308905     History of Changes
Other Study ID Numbers: WSU 2009-031
Study First Received: February 22, 2011
Last Updated: May 16, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Barbara Ann Karmanos Cancer Institute:
Neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Alovudine
Dideoxynucleosides
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014