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18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03541720
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Tracking Information
First Submitted Date  ICMJE May 2, 2018
First Posted Date  ICMJE May 30, 2018
Last Update Posted Date January 14, 2020
Actual Study Start Date  ICMJE March 14, 2019
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
Adverse event rate [ Time Frame: up to 2 days following injection of the radiotracer 18F-DA. ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
Adverse event rate [ Time Frame: up to 2 days following injection of the radiotracer 18F. ]
The adverse events will be recorded and monitored up to two days after the injection of radiotracer 18F-DA. The adverse event rate its 95% CI 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.
Change History Complete list of historical versions of study NCT03541720 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
  • The frequency of localization of 18F-DA in different organs. [ Time Frame: up to half year following injection of the radiotracer 18F-DA. ]
    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 [ Time Frame: up to half year following injection of the radiotracer 18F-DA. ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
  • The frequency of localization of 18F-DA in different organs. [ Time Frame: up to half year following injection of the radiotracer 18F. ]
    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 [ Time Frame: up to half year following injection of the radiotracer 18F. ]
    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.
Current Other Pre-specified Outcome Measures
 (submitted: June 4, 2018)
Mean and standard deviation of the difference of Curie scoring of 18F-DA and 123I-mIBG imaging [ Time Frame: up to half year following injection of the radiotracer 18F-DA. ]
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.
Original Other Pre-specified Outcome Measures
 (submitted: May 17, 2018)
Mean and standard deviation of the difference of Curie scoring of 18F-DA and 123I-mIBG imaging [ Time Frame: up to half year following injection of the radiotracer 18F. ]
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.
 
Descriptive Information
Brief Title  ICMJE 18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma
Official Title  ICMJE 18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Neuroblastoma
  • Pheochromocytoma
Intervention  ICMJE Drug: 18F-DA
18F-DA is an investigational PET radiotracer
Study Arms  ICMJE Experimental: Injection of 18F-DA
18F-DA will be injected into a vein in the arm or leg, or via central venous access line.
Intervention: Drug: 18F-DA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 17, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Barry Shulkin, MD 866-278-5833 referralinfo@stjude.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03541720
Other Study ID Numbers  ICMJE FLOPET
NCI-2018-01306 ( Registry Identifier: NCI Clinical Trial Registration Program )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Jude Children's Research Hospital
Study Sponsor  ICMJE St. Jude Children's Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barry Shulkin, MD St. Jude Children's Research Hospital
PRS Account St. Jude Children's Research Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP