Detroit, Michigan 48201


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

WSU 2009-031


NCT ID:

NCT01308905


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

21 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Barbara Ann Karmanos Cancer Institute


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

50


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Anthony F. Shields, M.D., Ph.D.
Principal Investigator
Barbara Ann Karmanos Cancer Institute
Primary Contact:Zhihong J Wang, M.D., Ph.D.
(313) 966-7772
jwang2@wayne.edu
Backup Contact:Anthony F Shields, M.D., Ph.D
(313) 576-8735
shieldsa@karmanos.org

Study Dates

Start Date:February 2011
Completion Date:February 2018
Completion Type:Anticipated
Primary Completion Date:February 2018
Primary Completion Type:Anticipated
Verification Date:April 2017
Last Changed Date:April 4, 2017
First Received Date:February 22, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To evaluate the utility of FLT-PET in early assessment of patient response to treatment.
Time Frame:1st PET - At diagnosis
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To determine whether 18F-FLT-PET is a sensitive tool to image neuroblastoma.
Time Frame:1st PET - At diagnosis
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:FLT-PET
Description:PET scan will be conducted at diagnosis, at the end of the first cycle of treatment and prior to the surgical procedure (resection).
Arm Name:FLT-PET

Study Arms

Study Arm Type:Experimental
Arm Name:FLT-PET
Description: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. Low risk patients: observation only. Intermediate risk patients: chemotherapy stratified according to risk sub-groups followed by surgical resection. High risk patients

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Barbara Ann Karmanos Cancer Institute
Agency Class:Other
Agency Type:Collaborator
Agency Name:Children's Hospital of Michigan

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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