Recruiting

Radiation & Chemotherapy

Sponsor:

Barbara Ann Karmanos Cancer Institute

Code:

NCT01308905

Conditions

Neuroblastoma

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

FLT-PET

Study Details

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

Study ID

NCT01308905

Start date

Feb, 2011

Status verified date

Apr, 2017

Completion date

Feb, 2018

Anticipated

Primary completion date

Feb, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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).

Interventions

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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

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

(313) 966-7772jwang2@wayne.edu

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

(313) 576-8735shieldsa@karmanos.org

Locations

Children's Hospital of Michigan

Recruiting

Detroit, Michigan, United States, 48201

Contacts

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

313-577-5515

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

(313) 576-8735

More Information

Sponsor

Barbara Ann Karmanos Cancer Institute

Last update posted

Apr 6, 2017

Last verified

Apr, 2017

Keywords

  • Neuroblastoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Barbara Ann Karmanos Cancer Institute on 2017-04-06.