Back to results

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

Primary Purpose

Neuroblastoma

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FLT-PET

About this trial

This is an interventional diagnostic trial for Neuroblastoma focused on measuring Neuroblastoma

Eligibility Criteria

1 Day - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Children's Hospital of MichiganRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FLT-PET

Arm 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: 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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT01308905

First Posted

February 22, 2011

Last Updated

April 4, 2017

Sponsor

Barbara Ann Karmanos Cancer Institute

Collaborators

Children's Hospital of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT01308905

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 2011 (undefined)

Primary Completion Date

February 2018 (Anticipated)

Study Completion Date

February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Barbara Ann Karmanos Cancer Institute

Collaborators

Children's Hospital of Michigan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroblastoma

Keywords

Neuroblastoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FLT-PET

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

FLT-PET

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

1st PET - At diagnosis

Secondary Outcome Measure Information:

Title

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

Time Frame

1st PET - At diagnosis

Title

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)

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

(313) 966-7772

jwang2@wayne.edu

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

(313) 576-8735

shieldsa@karmanos.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Barbara Ann Karmanos Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital of Michigan

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

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

Phone

313-577-5515

First Name & Middle Initial & Last Name & Degree

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

Phone

(313) 576-8735

First Name & Middle Initial & Last Name & Degree

Majid Khalaf, M.D.

First Name & Middle Initial & Last Name & Degree

Yaddanapudi Ravindranath, M.D.

First Name & Middle Initial & Last Name & Degree

Diane Chugani, Ph.D.

First Name & Middle Initial & Last Name & Degree

Thomas Mangner, Ph.D.

First Name & Middle Initial & Last Name & Degree

Otto Muzik, Ph.D.

First Name & Middle Initial & Last Name & Degree

Jeffrey Taub, M.D.

First Name & Middle Initial & Last Name & Degree

Sureyya Savasan, M.D.

First Name & Middle Initial & Last Name & Degree

Roland Chu, M.D.

First Name & Middle Initial & Last Name & Degree

Kanta Bhambhani, M.D.

First Name & Middle Initial & Last Name & Degree

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

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs