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18F-DA PET Scan for Neuroblastoma

Phase < 1
Recruiting
Led By Barry Shulkin, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have
Patients less than 3 years of age who require a total length of anesthesia time greater than 3 hours (for the FLOPET scan in conjunction with another clinical procedure requiring sedation) will be excluded from the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to half year following injection of the radiotracer 18f-da.
Awards & highlights
No Placebo-Only Group

Summary

This trial will use PET scans combined with a radioactive tracer (18F-DA) to examine neuroblastoma tumors. The goal is to see if this tracer is safe and more effective than the current standard (123I-mIBG).

Who is the study for?
This trial is for children over 1 year old with known or suspected neuroblastoma or pheochromocytoma, under a St. Jude physician's care. Participants must not be pregnant, breastfeeding, and should avoid pregnancy within one month after the scan. Those on certain medications may need to stop them before joining.
What is being tested?
The study tests if a PET scan using the tracer 18F-DA is safe and more effective than the current standard (123I-mIBG) in detecting small areas of neuroblastoma and pheochromocytoma tumors in about 20 patients at St. Jude.
What are the potential side effects?
While specific side effects are not listed for this imaging study, potential risks generally include exposure to radiation which could lead to long-term health issues like cancer.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under 3 years old and need anesthesia for more than 3 hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to half year following injection of the radiotracer 18f-da.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to half year following injection of the radiotracer 18f-da. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse event rate
Secondary study objectives
The frequency of localization of 18F-DA in different organs.
max SUV from 18F-DA and 123I-mIBG PET
Other study objectives
Mean and standard deviation of the difference of Curie scoring of 18F-DA and 123I-mIBG imaging

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Injection of 18F-DAExperimental Treatment1 Intervention
18F-DA will be injected into a vein in the arm or leg, or via central venous access line.

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
443 Previous Clinical Trials
5,305,461 Total Patients Enrolled
24 Trials studying Neuroblastoma
5,976 Patients Enrolled for Neuroblastoma
Barry Shulkin, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

Media Library

18F-DA Clinical Trial Eligibility Overview. Trial Name: NCT03541720 — Phase < 1
Neuroblastoma Research Study Groups: Injection of 18F-DA
Neuroblastoma Clinical Trial 2023: 18F-DA Highlights & Side Effects. Trial Name: NCT03541720 — Phase < 1
18F-DA 2023 Treatment Timeline for Medical Study. Trial Name: NCT03541720 — Phase < 1
~6 spots leftby Jul 2027
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