18F-DOPA PET/CT Imaging Optimization
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: University of Alberta
Disqualifiers: Pregnancy, Weight >225 kg, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug 18F-DOPA in the clinical trial?
Research shows that 18F-DOPA PET imaging is useful for detecting and managing brain tumors, movement disorders, and neuroendocrine tumors. It has been used effectively in imaging for Parkinson's disease and carcinoid tumors, helping to locate tumors more accurately than some traditional methods.
12345Is 18F-DOPA PET/CT imaging safe for humans?
18F-DOPA has been used safely for many years in imaging for Parkinson's disease and neuroendocrine tumors. Some formulations may cause a mild burning sensation at the injection site, but studies have shown that new formulations are well-tolerated in cell and animal tests.
23567How does the drug 18F-DOPA differ from other treatments for neuroendocrine tumors?
18F-DOPA is unique because it is a radiotracer used in PET/CT imaging to detect and manage neuroendocrine tumors by mimicking the natural amino acid L-DOPA, which is taken up by specific transporters in the body. This allows for precise imaging of tumor activity, which is different from traditional treatments that may not provide such detailed visualization.
238910Eligibility Criteria
This trial is for children and adults with certain conditions like congenital hyperinsulinism, neuroendocrine tumors, brain tumors, Parkinson's disease or Lewy body dementia. It excludes pregnant individuals, those over 225 kg, patients who can't lie flat for the scan duration or give consent, and young kids who can't be sedated safely.Inclusion Criteria
I am under or over 18 and may have a neuroendocrine tumor.
I am an adult suspected to have Parkinson's disease or Lewy body dementia.
I am under 18 and have been diagnosed with congenital hyperinsulinism.
+2 more
Exclusion Criteria
I cannot lie flat for 20-30 minutes.
You do not have a way for the study drug to be given through a vein.
Unable to obtain consent
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
1 visit (in-person)
Imaging and Assessment
Participants receive an 18F-DOPA PET/CT scan to assess image optimization and gallbladder activity patterns
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after imaging
1 month
1 visit (in-person)
Participant Groups
The study tests how well a PET/CT imaging technique works using an injection of Furosemide and a radioactive drug called 18F-DOPA. The goal is to optimize images for better diagnosis in various diseases including brain tumors and Parkinson's.
1Treatment groups
Experimental Treatment
Group I: 18F-DOPA injectionExperimental Treatment2 Interventions
All enrolled participants will receive an intravenous injection of the investigational 18F-DOPA radiopharmaceutical
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
WC Mackenzie Health Science Centre / University of Alberta HospitalEdmonton, Canada
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Who Is Running the Clinical Trial?
University of AlbertaLead Sponsor
References
18F-DOPA PET/CT Physiological Distribution and Pitfalls: Experience in 215 Patients. [2018]F-DOPA PET/CT is potentially helpful in the management of patients with low-grade brain tumors, movement disorders, and somatic neuroendocrine tumors. We describe the whole-body physiological distribution of F-DOPA uptake.
Radiosynthesis and biological evaluation of N-(2-[18F]fluoropropionyl)-3,4-dihydroxy-l-phenylalanine as a PET tracer for oncologic imaging. [2018]Label="INTRODUCTION" NlmCategory="BACKGROUND">Several 11C and 18F labeled 3,4-dihydroxy-l-phenylalanine (l-DOPA) analogues have been used for neurologic and oncologic diseases, especially for brain tumors and neuroendocrine tumors PET imaging. However, 18F-labeled N-substituted l-DOPA analogues have not been reported so far. In the current study, radiosynthesis and biological evaluation of a new 18F-labeled l-DOPA analogue, N-(2-[18F]fluoropropionyl)-3,4-dihydroxy-l-phenylalanine ([18F]FPDOPA) for tumor PET imaging are performed.
Pharmaceutical development of novel lactate-based 6-fluoro-l-DOPA formulations. [2017]6-[18F]fluoro-l-dihydroxyphenylalanine (18F-DOPA) is a diagnostic positron emission tomography (PET) agent, which has been used for decades in imaging the loss of dopaminergic neurons in Parkinson's disease, and more recently to detect, stage and restage neuroendocrine tumors (NETs) and to search for recurrence of viable glioma tissue. The commercially available 18F-DOPA PET radiopharmaceutical for diagnostic use in European Union countries, is formulated in an aqueous solution of acetic acid (1.05mg/mL) and has the disadvantages that, immediately before injection, the pH must be adjusted to 4.0-5.0 by the addition of a sterile solution of sodium bicarbonate (84mg/mL) causing a light and transient burning sensation at the injection site. To overcome these drawbacks, preformulation studies were accomplished to confirm that F-DOPA degradation was affected by pH. Hence, two formulations of F-DOPA, namely ND1 and ND2, were prepared maintaining the pH=5.0 using 1mM l-(+)-lactate buffer, excluding oxygen, and incorporating in the formula the chelating agent Na2EDTA (1mM). F-DOPA oxygen exposure, the presence of free metal cations in formulation and high pH values seem to promote F-DOPA degradation. The resulting formulations proved to guarantee the chemical stability of F-DOPA in solution at pH5.0, value also compatible with the direct infusion. In vitro cell viability tests on mouse skeletal muscle fibers, renal tsa201 and neuronal SH-SY5Y cell lines, and in vivo studies in rats reported elsewhere, showed cell tolerability to the new F-DOPA formulations providing the basis for their further in vivo evaluation.
Staging of carcinoid tumours with 18F-DOPA PET: a prospective, diagnostic accuracy study. [2022]To assess individual treatment options for patients with carcinoid tumours, accurate knowledge of tumour localisation is essential. We aimed to test the diagnostic sensitivity of 6-[fluoride-18]fluoro-levodopa ((18)F-DOPA PET), compared with conventional imaging methods, in patients with carcinoid tumours.
Prospective F-18 FDOPA PET Imaging Study in Human PD. [2023]We present the findings of our final prospective study submitted to the U.S. Food and Drug Administration (FDA) for New Drug Application (NDA) approval for the use of 3,4-dihydroxy-6-[18F]fluoro-l-phenylalanine (F-18 FDOPA) positron emission tomography (PET) imaging for Parkinson's disease (PD). The primary aim was to determine the sensitivity, specificity, and predictive values of F-18 FDOPA PET in parkinsonian patients with respect to clinical standard-of-truth (SOT). Secondary outcomes included the inter-rater reliability, and correlation of quantitative measures for PET with dopaminergic status.
Meta-analysis of the adverse events associated with extended-release versus standard immediate-release pramipexole in Parkinson disease. [2022]In order to increase treatment choices for patients with Parkinson disease (PD), we performed a retrospective assessment of adverse events associated with a novel once-daily extended-release (ER) formulation versus the standard immediate-release (IR) of the nonergolinic dopamine agonist, pramipexole.
In vivo biodistribution of no-carrier-added 6-18F-fluoro-3,4-dihydroxy-L-phenylalanine (18F-DOPA), produced by a new nucleophilic substitution approach, compared with carrier-added 18F-DOPA, prepared by conventional electrophilic substitution. [2022]A novel synthetic approach to 6-(18)F-fluoro-3,4-dihydroxy-L-phenylalanine ((18)F-DOPA), involving the nucleophilic substitution of a diaryliodonium salt precursor with non-carrier-added (18)F-fluoride, yielded a product with a specific activity that was 3 orders of magnitude higher than the product of the conventional synthesis method, involving an electrophilic substitution of a trialkylstannane precursor with (18)F2. We performed a direct comparison of high- and low-specific-activity (18)F-DOPA in a neuroendocrine tumor model to determine whether this difference in specific activity has implications for the biologic behavior and imaging properties of (18)F-DOPA.
GMP production of 6-[18F]Fluoro-L-DOPA for PET/CT imaging by different synthetic routes: a three center experience. [2021]Label="BACKGROUND" NlmCategory="BACKGROUND">The radiofluorinated levodopa analogue 6-[18F]F-L-DOPA (3,4-dihydroxy-6-18F-L-phenylalanine) is a commonly employed radiotracer for PET/CT imaging of multiple oncological and neurological indications. An unusually large number of different radiosyntheses have been published to the point where two different Ph. Eur. monographs exist depending on whether the chemistry relies on electrophilic or nucleophilic radiosubstitution of appropriate chemical precursors. For new PET imaging sites wishing to adopt [18F]FDOPA into clinical practice, selecting the appropriate production process may be difficult and dependent on the clinical needs of the site.
Overexpression of L-Type Amino Acid Transporter 1 (LAT1) and 2 (LAT2): Novel Markers of Neuroendocrine Tumors. [2019]6-18F-fluoro-L-3,4-dihydroxyphenylalanine (18F-FDOPA) PET is a useful tool in the clinical management of pheochromocytoma (PHEO) and medullary thyroid carcinoma (MTC). 18F-FDOPA is a large neutral amino acid biochemically resembling endogenous L-DOPA and taken up by the L-type amino acid transporters (LAT1 and LAT2). This study was conducted to examine the expression of the LAT system in PHEO and MTC.
Correlation of 6-18F-fluoro-L-dopa PET uptake with proliferation and tumor grade in newly diagnosed and recurrent gliomas. [2016]6-(18)F-fluoro-l-dopa ((18)F-FDOPA) measured with PET as a biomarker of amino acid uptake has been investigated in brain tumor imaging. The aims of the current study were to determine whether the degree of (18)F-FDOPA uptake in brain tumors predicted tumor grade and was associated with tumor proliferative activity in newly diagnosed and recurrent gliomas.