NeuroblastomaNCT01308905
Monitor Response to Treatment in Neuroblastoma Using 3&Apos;-Deoxy-3&Apos;-Fluorothymidine- Positron Emission Tomography (FLT-PET)
A study testing FLT-PET in people with Neuroblastoma, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 21 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- FLT-PET
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Michigan
Detroit, Michigan, 48201
Zhihong J Wang, M.D., Ph.D., 313-577-5515
Anthony F Shields, M.D., Ph.D., (313) 576-8735
About this study
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
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.
Read the 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.
- Conditions
- Neuroblastoma
- Being tested
- FLT-PET
- Keywords
- Neuroblastoma
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLT-PETDevice
PET scan will be conducted at diagnosis, at the end of the first cycle of treatment and prior to the surgical procedure (resection).
| Study group | Role | What they receive |
|---|---|---|
| FLT-PET | Experimental | 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). Receives: Device: FLT-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether 18F-FLT-PET is a sensitive tool to image neuroblastoma.
Measured: 1st PET - At diagnosis
Secondary outcomes (3)
To evaluate the utility of FLT-PET in early assessment of patient response to treatment.
Measured: 1st PET - At diagnosis
To evaluate the utility of FLT-PET in early assessment of patient response to
Measured: 2nd PET - Approx. 3 wks (end of 1st cycle)
To evaluate the utility of FLT-PET in early assessment of patient response to treatment.
Measured: 3rd PET: 6-15 wks (Prior to surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Michigan
- Responsible party
- Principal investigator, Zhihong Wang, Barbara Ann Karmanos Cancer Institute
- Investigators
- Anthony F. Shields, M.D., Ph.D., Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308905
- Sponsor's protocol ID
- WSU 2009-031
- Status last verified
- Apr 2017
- First submitted
- 22 Feb 2011
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01308905
- Acronym / sponsor ID
- WSU 2009-031
- Conditions
- Neuroblastoma
- Keywords
- Neuroblastoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- Children's Hospital of Michigan
- Study start
- Feb 2011
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PET scans will be performed to show the distribution throughout the body of substances containing a small amount of radioactive material.
| Arm | Type | Receives |
|---|---|---|
| FLT-PET | Experimental | Device: FLT-PETPatients 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). |
Who may qualify
- Ages
- 1 day to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLT-PETPET 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 |
Primary outcome
To determine whether 18F-FLT-PET is a sensitive tool to image neuroblastoma.
Time frame: 1st PET - At diagnosis
3 secondary outcomes
To evaluate the utility of FLT-PET in early assessment of patient response to treatment.
Time frame: 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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony F. Shields, M.D., Ph.D. principal investigator
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLT-PET in people with Neuroblastoma, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhihong J Wang, M.D., Ph.D. ((313) 966-7772, jwang2@wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether 18F-FLT-PET is a sensitive tool to image neuroblastoma. (time frame: 1st PET - At diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.