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18F-DOPA II - PET Imaging Optimization

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ClinicalTrials.gov Identifier: NCT04706910
Recruitment Status : Recruiting
First Posted : January 13, 2021
Last Update Posted : April 13, 2022
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Brief Summary:

A single centre non-randomized, non-blinded phase III prospective cohort study of 18F-DOPA PET/CT imaging in specific patient populations:

  1. Pediatric patients (less than 18 years old) with congenital hyperinsulinism.
  2. Pediatric patients (less than 18 years old) with neuroblastoma.
  3. Pediatric (less than 18 years old) or Adult patients (18 or older) with known or clinically suspected neuroendocrine tumor.
  4. Adult patients (18 or older) with a clinical suspicion of Parkinson's disease or Lewy body dementia.
  5. Pediatric (less than 18 years old) or Adult patients (18 or older) with brain tumors.

Image optimization (the primary study objective) and gallbladder activity pattern (the secondary objective) will be evaluated.


Condition or disease Intervention/treatment Phase
Congenital Hyperinsulinism Neuroblastoma Parkinson Disease Lewy Body Disease Neuroendocrine Tumors Brain Tumor Drug: 18F-DOPA Drug: Furosemide Injection Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-DOPA II - PET Imaging Optimization
Actual Study Start Date : January 20, 2021
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : July 2026


Arm Intervention/treatment
Experimental: 18F-DOPA injection
All enrolled participants will receive an intravenous injection of the investigational 18F-DOPA radiopharmaceutical
Drug: 18F-DOPA
All participants will receive an intravenous injection of 18F-DOPA (4MBq/kg; minimum 110 MBq, maximum 600 MBq) for this study
Other Name: 18F-dihydroxyphenylalanine

Drug: Furosemide Injection
Some participants will receive an intravenous injection of furosemide (40mg, single dose)
Other Name: 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid




Primary Outcome Measures :
  1. Minimum lesion detectibility (size) [ Time Frame: Within 1 month of PET/CT scan ]
    Measurement of size (mm) of the three smallest lesions

  2. Assessment of bladder activity [ Time Frame: Within 1 month of PET/CT scan ]
    Measurement of standardized uptake value (SUV) for urinary bladder activity

  3. Assessment of bladder activity artifact [ Time Frame: Within 1 month of PET/CT scan ]
    Subjective scoring (0-2 scale) of image artifact in pelvis related to bladder activity

  4. Minimum lesion detectability (SUV) [ Time Frame: Within 1 month of PET/CT scan ]
    Measurement of the standardized uptake value (SUV) of the three smallest lesions


Secondary Outcome Measures :
  1. Gallbladder activity pattern [ Time Frame: Within 3 months of PET/CT scan ]
    Assessment of SUVmax of various segments of the biliary tree at different time points after 18F-DOPA injection using a subgroup of participants (64 total)

  2. Gallbladder disease questionnaire [ Time Frame: At the time of enrollment ]
    All participants will complete a questionnaire regarding a history of gallbladder disease



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pediatric patients (less than 18 years old) with congenital hyperinsulinism.
  2. Pediatric patients (less than 18 years old) with neuroblastoma.
  3. Pediatric (less than 18 years old) or Adult patients (18 or older) with known or clinically suspected neuroendocrine tumor.
  4. Adult patients (18 or older) with a clinical suspicion of Parkinson's disease or Lewy body dementia.
  5. Pediatric (less than 18 years old) or Adult patients (18 or older) with brain tumors.

Exclusion Criteria:

  1. Unable to obtain consent
  2. Weight >225 kg (weight limitation of PET/CT scanner)
  3. Adult patients unable to lie flat for 20-30 minutes to complete the PET-CT session.
  4. Young pediatric patients (less than 13 years old) who are unable to lie flat for 20-30 minutes and for whom clinical sedation is contraindicated (as determined by a pediatric anaesthesiologist).
  5. Lack of intravenous access
  6. History of previous cholecystectomy (excluded from dynamic abdomen sub-study only)
  7. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04706910


Contacts
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Contact: Jonathan Abele, MD 1-780-407-6907 jabele@ualberta.ca

Locations
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Canada, Alberta
WC Mackenzie Health Science Centre / University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Jonathan Abele, MD    780-407-6907    jabele@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Jonathan Abele, MD University of Alberta
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT04706910    
Other Study ID Numbers: Pro00100294
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: April 13, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroblastoma
Neuroendocrine Tumors
Congenital Hyperinsulinism
Nesidioblastosis
Parkinson Disease
Lewy Body Disease
Hyperinsulinism
Neoplasms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Glucose Metabolism Disorders
Metabolic Diseases
Dementia
Neurocognitive Disorders
Mental Disorders
Pancreatic Diseases