Back to results18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma
Primary Purpose
Neuroblastoma, Pheochromocytoma
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-DA
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuroblastoma
Eligibility Criteria
Inclusion Criteria:
Patients with known or suspected neuroblastoma or pheochromocytoma are eligible. 18F-DA PET/CT scanning will not be the initial imaging study in a newly diagnosed patient.
Patients with positive findings on prior imaging within the past 4 weeks are eligible.
Prior therapy is allowed.
Patients > 1 year of age, under the care of a SJCRH physician.
Patients of both genders, and all ethnic groups, under the care of a SJCRH physician.
Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.
Informed consent signed by participant, parent, or guardian according to the guidelines of the institutional review board.
Exclusion Criteria:
Inability or unwillingness of patient, parent, or guardian to consent.
Pregnancy or lactation. Future plans for pregnancy do not exclude patient participation. Patient should not become pregnant within one month of completion of 18F-DA PET scan.
Use of medications known to interfere with 123I-mIBG uptake (principal considerations are phenylephrine and pseudoephedrine containing compounds which need to be discontinued for 48 hours, and labetalol which needs to be discontinued for 6 weeks).
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.
Sites / Locations
- St. Jude Children's Research HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Injection of 18F-DA
Arm Description
18F-DA will be injected into a vein in the arm or leg, or via central venous access line.
Outcomes
Primary Outcome Measures
Adverse event rate
The adverse events will be recorded and monitored up to two days after the injection of radiotracer 18F-DA. The 95% CI for the adverse event rate will be calculated and reported. If one adverse event grade 2 or above, attributable to study drug, the study will be stopped until completion of IRB review and a decision about whether the study should be modified or closed.
Secondary Outcome Measures
The frequency of localization of 18F-DA in different organs.
The localization of 18F-DA throughout the whole body will be described descriptively in different organs such as salivary glands, heart, liver, kidneys, bladder, and bowel. The frequency of the localization of 18F-DA in those regions will be listed. Unexpected sites of uptake, such as bone or focally within soft tissue, are not normal and will be considered abnormal and documented descriptively as well.
max SUV from 18F-DA and 123I-mIBG PET
Standardized uptake values of soft tissue and tumor (SUV) will be generated by drawing regions of interest on the images scaled to SUV. Descriptive statistics of SUV values, such as max SUV, from 18F-DA and 123I-mIBG PET will be provided.
Full Information
NCT ID
NCT03541720
First Posted
May 2, 2018
Last Updated
March 28, 2023
Sponsor
St. Jude Children's Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03541720
Brief Title
18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma
Official Title
18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Jude Children's Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
PET (positron emission tomography) scans combined with a radioactive tracer will be used to identify and analyze tumors. Currently, the most common tracer used to analyze neuroblastoma tumors is called 123I-mIBG. However, the picture it provides is not always clear enough to see the very small areas of the disease.
18F-DA (18F-fluorodopamine) has been shown to be safe and more effective than 123I-mIBG in analyzing the tumor pheochromocytoma, which is closely related to neuroblastoma.
With this research study, the investigators plan to meet the following goals:
Investigate to see if 18F-DA is safe to administer to pediatric patients with known or suspected neuroblastoma or pheochromocytoma
Examine where in the body 18F-DA goes.
Obtain information comparing 18F-DA to 123I-mIBG to see if 18F-DA could replace 123I-mIBG in the future.
About 20 people, with known or suspected neuroblastoma or pheochromocytoma, will take part in this Pilot study at St. Jude.
Detailed Description
Neuroblastoma is the most common extracranial malignant tumor of childhood. Nuclear imaging with 123I-mIBG is the standard test to follow and manage these patients. Because of the inherent imaging characteristics of I-123, there is suboptimal resolution within the images, causing them to appear somewhat blurry, which reduces our ability to find small areas of disease. A chemical that uses positron emission tomography should allow much better resolution of the images, which could improve patient care by allowing us to find small areas of disease that, if untreated, could result in tumor relapse. We have developed 18F-fluorodopamine (18F-DA) for PET imaging in our patients with neuroblastoma.
The primary objective is to explore the safety of 18F-DA in patients with known or suspected neuroblastoma or pheochromocytoma. The secondary objectives are to evaluate the biodistribution of 18F-DA in patients with neuroblastoma and compare the biodistribution of 18F-DA with the biodistribution of 123I-mIBG.
Patients receive an intravenous injection of a small (tracer) dose of 18F-DA. Approximately 1 hour later, patients undergo PET scanning of the entire body to evaluate the localization of the tracer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma, Pheochromocytoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
18F-DA scans will be performed within 4 weeks of standard imaging evaluations, such as CT (computed tomography) and I-123mIBG scanning.
18F-DA will be injected into a vein in the arm or leg, or via central venous access line.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Injection of 18F-DA
Arm Type
Experimental
Arm Description
18F-DA will be injected into a vein in the arm or leg, or via central venous access line.
Intervention Type
Drug
Intervention Name(s)
18F-DA
Intervention Description
18F-DA is an investigational PET radiotracer
Primary Outcome Measure Information:
Title
Adverse event rate
Description
The adverse events will be recorded and monitored up to two days after the injection of radiotracer 18F-DA. The 95% CI for the adverse event rate will be calculated and reported. If one adverse event grade 2 or above, attributable to study drug, the study will be stopped until completion of IRB review and a decision about whether the study should be modified or closed.
Time Frame
up to 2 days following injection of the radiotracer 18F-DA.
Secondary Outcome Measure Information:
Title
The frequency of localization of 18F-DA in different organs.
Description
The localization of 18F-DA throughout the whole body will be described descriptively in different organs such as salivary glands, heart, liver, kidneys, bladder, and bowel. The frequency of the localization of 18F-DA in those regions will be listed. Unexpected sites of uptake, such as bone or focally within soft tissue, are not normal and will be considered abnormal and documented descriptively as well.
Time Frame
up to half year following injection of the radiotracer 18F-DA.
Title
max SUV from 18F-DA and 123I-mIBG PET
Description
Standardized uptake values of soft tissue and tumor (SUV) will be generated by drawing regions of interest on the images scaled to SUV. Descriptive statistics of SUV values, such as max SUV, from 18F-DA and 123I-mIBG PET will be provided.
Time Frame
up to half year following injection of the radiotracer 18F-DA.
Other Pre-specified Outcome Measures:
Title
Mean and standard deviation of the difference of Curie scoring of 18F-DA and 123I-mIBG imaging
Description
The Curie scoring of 18F-DA and 123I-mIBG imaging will be scored for each participant. The difference of the Curie scoring between the two imaging will be calculated for each patient. Summary statistics of the difference such as mean and standard deviation would be calculated. One sample t test or signed rank test may be used to test whether the difference is equal to 0 depending on whether the distribution of the difference is normal or not.
Time Frame
up to half year following injection of the radiotracer 18F-DA.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with known or suspected neuroblastoma or pheochromocytoma are eligible. 18F-DA PET/CT scanning will not be the initial imaging study in a newly diagnosed patient.
Patients with positive findings on prior imaging within the past 4 weeks are eligible.
Prior therapy is allowed.
Patients > 1 year of age, under the care of a SJCRH physician.
Patients of both genders, and all ethnic groups, under the care of a SJCRH physician.
Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.
Informed consent signed by participant, parent, or guardian according to the guidelines of the institutional review board.
Exclusion Criteria:
Inability or unwillingness of patient, parent, or guardian to consent.
Pregnancy or lactation. Future plans for pregnancy do not exclude patient participation. Patient should not become pregnant within one month of completion of 18F-DA PET scan.
Use of medications known to interfere with 123I-mIBG uptake (principal considerations are phenylephrine and pseudoephedrine containing compounds which need to be discontinued for 48 hours, and labetalol which needs to be discontinued for 6 weeks).
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barry Shulkin, MD
Phone
866-278-5833
Email
referralinfo@stjude.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Shulkin, MD
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barry L Shulkin, MD
Phone
866-278-5833
Email
referralinfo@stjude.org
First Name & Middle Initial & Last Name & Degree
Barry L Shulkin, MD
12. IPD Sharing Statement
Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital
URL
http://www.stjude.org/protocols
Description
Clinical Trials Open at St. Jude
Learn more about this trial
18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma
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