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

April 4, 2017 updated by: Zhihong Wang, Barbara Ann Karmanos Cancer Institute

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhihong J Wang, M.D., Ph.D.
  • Phone Number: (313) 966-7772
  • Email: jwang2@wayne.edu

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Children's Hospital of Michigan
        • Contact:
          • Zhihong J Wang, M.D., Ph.D.
          • Phone Number: 313-577-5515
        • Contact:
          • Anthony F Shields, M.D., Ph.D.
          • Phone Number: (313) 576-8735
        • Sub-Investigator:
          • Majid Khalaf, M.D.
        • Sub-Investigator:
          • Yaddanapudi Ravindranath, M.D.
        • Sub-Investigator:
          • Diane Chugani, 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine whether 18F-FLT-PET is a sensitive tool to image neuroblastoma.
Time Frame: 1st PET - At diagnosis
1st PET - At diagnosis

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the utility of FLT-PET in early assessment of patient response to treatment.
Time Frame: 1st PET - At diagnosis
1st PET - At diagnosis
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)
2nd PET - Approx. 3 wks (end of 1st cycle)
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)
3rd PET: 6-15 wks (Prior to surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barbara Ann Karmanos Cancer Institute

Collaborators

Children's Hospital of Michigan

Investigators

  • Principal Investigator: Anthony F. Shields, M.D., Ph.D., Barbara Ann Karmanos Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

February 22, 2011

First Submitted That Met QC Criteria

March 3, 2011

First Posted (Estimate)

March 4, 2011

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WSU 2009-031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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