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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to half year following injection of the radiotracer 18f-da.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to half year following injection of the radiotracer 18f-da.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to half year following injection of the radiotracer 18f-da.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse event rate
Secondary outcome measures
The frequency of localization of 18F-DA in different organs.
max SUV from 18F-DA and 123I-mIBG PET
Other outcome measures
Mean and standard deviation of the difference of Curie scoring of 18F-DA and 123I-mIBG imaging
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.
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Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
428 Previous Clinical Trials
5,306,593 Total Patients Enrolled
23 Trials studying Neuroblastoma
7,004 Patients Enrolled for Neuroblastoma
Barry Shulkin, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have stopped taking medications like phenylephrine and pseudoephedrine for 2 days, and labetalol for 6 weeks.I am under the care of a St. Jude Children's Research Hospital doctor.I am not breastfeeding as I might need to undergo treatments involving radiation.I am under 3 years old and need anesthesia for more than 3 hours.You have had a positive result on a recent imaging test within the last 4 weeks.I have or might have neuroblastoma or pheochromocytoma.I am over 1 year old and being treated by a SJCRH doctor.I have received treatment for my condition before.
Research Study Groups:
This trial has the following groups:- Group 1: Injection of 18F-DA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have been included in this experiment thus far?
"Indeed, the data hosted on clinicaltrials.gov affirms that this research endeavour is presently recruiting for participants. This trial was initially published on March 14th 2019 and last amended on February 15th 2022; 20 people are needed at one site to join in."
Answered by AI
Are there any remaining vacancies for participants in this experiment?
"Data from clinicaltrials.gov indicates that, as of this time, enrollment for the trial is open. Initially posted on March 14th 2019, it was last updated on February 15th 2022."
Answered by AI
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