PET/CT Scans for Neuroendocrine Cancer
Recruiting in Palo Alto (17 mi)
Overseen byJonathan Abele
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Alberta
Disqualifiers: Pregnant, Breastfeeding, Allergic to 18F-DOPA, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
This study is a single centre non-randomized non-blinded phase II prospective cohort study including 50 participants. The objective of this study is to directly compare 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG activity in patients with metastatic neuroendocrine tumors (NETs) on a lesion-by-lesion basis. The investigators will determine the prevalence of concordant versus discordant disease. Secondary objectives include assessing the standardized uptake value (SUV) and determining if there is any correlation between discordance and disease progression.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the drug 18F-DOPA for neuroendocrine cancer?
Is 18F-DOPA PET/CT safe for humans?
How does the PET/CT scan treatment for neuroendocrine cancer differ from other treatments?
The PET/CT scan using 18F-DOPA is unique because it provides highly sensitive imaging for neuroendocrine tumors by taking advantage of the tumors' ability to absorb certain substances, making it more effective than conventional imaging methods. This approach is particularly useful for detecting tumors that might be missed by traditional scans, offering a more accurate diagnosis and aiding in better clinical management.12457
Eligibility Criteria
This trial is for adults aged 40 or older with a confirmed diagnosis of neuroendocrine tumors, including various types such as gastrointestinal, pancreatic, pulmonary NETs and others. Participants must have at least two abnormal lesions that are positive on a specific PET/CT scan. It's not suitable for those over 225 kg, with serious illnesses affecting the study outcome, previous allergic reactions to the imaging drug used in the trial (18F-DOPA), pregnant or breastfeeding women, or those unable to undergo scans.Inclusion Criteria
Ability to provide written informed consent prior to participation in the study
I am 40 years old or older.
I have at least two lesions suspected to be a neuroendocrine tumor.
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Exclusion Criteria
I am under 40 years old.
Any medical condition, serious inter-current illness, or other extenuating circumstance that, in the opinion of the investigator or attending department physician, may significantly interfere with study performance or interpretation
Previous allergic reaction to 18F-DOPA
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Imaging
Participants undergo 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT scans to evaluate metastatic neuroendocrine tumors
1-2 weeks
3 visits (in-person)
Follow-up
Participants are monitored for disease progression and treatment response
18 months
Periodic assessments
Treatment Details
Interventions
- 18F-DOPA (Radiopharmaceutical)
Trial OverviewThe study compares three different PET/CT imaging agents—68Ga-HA-DOTATATE, 18F-DOPA with furosemide, and 18F-FDG—to see which one better detects metastatic neuroendocrine tumors on a lesion-by-lesion basis. The goal is also to understand if differences in tumor detection correlate with disease progression.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 18F-DOPA PET/CT scanExperimental Treatment1 Intervention
4 MBq/kg (minimum 100 MBq, maximum 600 MBq) 18F-DOPA injected intravenously with 40 mg furosemide and subsequent whole body PET/CT scan
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Alberta HospitalEdmonton, Canada
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Who Is Running the Clinical Trial?
University of AlbertaLead Sponsor
References
Pancreatic neuroendocrine tumors: diagnosis with PET. [2016]To evaluate the use of carbon-11-labeled L-dihydroxyphenylalanine (L-DOPA) and hydroxytryptophan (5-HTP) in the diagnosis of pancreatic endocrine tumors with positron emission tomography (PET).
6-L-18F-fluorodihydroxyphenylalanine PET in neuroendocrine tumors: basic aspects and emerging clinical applications. [2022]In recent years, 6-l-18F-fluorodihydroxyphenylalanine (18F-DOPA) PET has emerged as a new diagnostic tool for the imaging of neuroendocrine tumors. This application is based on the unique property of neuroendocrine tumors to produce and secrete various substances, a process that requires the uptake of metabolic precursors, which leads to the uptake of 18F-DOPA. This nonsystematic review first describes basic aspects of 18F-DOPA imaging, including radiosynthesis, factors involved in tracer uptake, and various aspects of metabolism and imaging. Subsequently, this review provides an overview of current clinical applications in neuroendocrine tumors, including carcinoid tumors, pancreatic islet cell tumors, pheochromocytoma, paraganglioma, medullary thyroid cancer, hyperinsulinism, and various other clinical entities. The application of PET/CT in carcinoid tumors has unsurpassed sensitivity. In medullary thyroid cancer, pheochromocytoma, and hyperinsulinism, results are also excellent and contribute significantly to clinical management. In the remaining conditions, the initial experience with 18F-DOPA PET indicates that it seems to be less valuable, but further study is required.
Value of combined 6-[18F]fluorodihydroxyphenylalanine PET/CT for imaging of neuroendocrine tumours. [2019]Accurate knowledge of tumour presence and location is essential to treat neuroendocrine tumours (NETs). Standard imaging has been hampered by low sensitivity and lack of spatial resolution. This study assessed prospectively the diagnostic value and impact of combined 6-[18F]fluorodihydroxyphenylalanine positron emission tomography-computed tomography (18F-DOPA-PET/CT) in the management of NET.
Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) positron emission tomography as a tool to localize an insulinoma or beta-cell hyperplasia in adult patients. [2022]Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) positron emission tomography (PET) is a promising method in localizing neuroendocrine tumors. Recently, it has been shown to differentiate focal forms of congenital hyperinsulinism of infancy. The current study was set up to determine the potential of 18F-DOPA PET in identifying the insulin-secreting tumors or beta-cell hyperplasia of the pancreas in adults.
Fluorine-18-fluorodihydroxyphenylalanine Positron-emission Tomography Scans of Neuroendocrine Tumors (Carcinoids and Pheochromocytomas). [2020]Conventional methods of imaging neuroendocrine tumors with computed tomography, magnetic resonance imaging, indium-111-octreotide, or radiolabeled metaiodobenzilguanidine scintigraphy have limitations. This pilot study tried to improve the localization of these tumors with fluorine-18-fluorodihydroxyphenylalanine (F-DOPA) positron-emission tomography (PET) scanning.
Limited role of carbidopa-assisted 18F-FDOPA PET/CT in patients with sporadic non-functional gastroduodenal neuroendocrine neoplasms. [2020]Label="OBJECTIVE" NlmCategory="OBJECTIVE">To evaluate 18F-fluorodihydroxyphenylalanine (18F-FDOPA) positron emission tomography/computed tomography (PET/CT) after carbidopa premedication to localize sporadic, well-differentiated, nonfunctioning gastroduodenal neuroendocrine neoplasms (NENs).
[Contemporary nuclear medicine diagnostics of neuroendocrine tumors]. [2019]The new positron emission tomography (PET/CT) methods for neuroendocrine tumors detection are presented and compared with classic, conventional methods. Conventional methods use a gamma scintillation camera for patients with neuroendocrine tumor imaging, after intravenous injection of one of the following radiopharmaceuticals: 1) somatostatin analogues labeled with indium-111 (111In-pentetreotide) or technetium-99m (99mTc-EDDA/HYNIC-TOC); 2) noradrenaline analogue labeled with iodine-131 or -123 (131/123I-MIBG); or 3) 99mTc(V)-DMSA. Contemporary methods use PET/CT equipment for patients with neuroendocrine tumor imaging, after intravenous injection of pharmaceuticals labeled with positron emitters [fluorine-18 (18F), galium-68 (68Ga), or carbon-11 (11C)]: 1) glucose analogue (18FDG); 2) somatostatin analogue (68Ga-DOTATOC/68Ga-DOTATATE/68Ga-DOTANOC); 3) aminoacid precursors of bioamines: [a) dopamine precursor 18F-DOPA (6-18F-dihydroxyphenylalanine), b) serotonin precursor 11C-5HTP (11C-5-hydroxytryptophan)]; or 4) dopamine analogue 18F-DA (6-18F-fluorodopamine). Conventional and contemporary (PET/ CT) somatostatin receptor detection showed identical high spe- cificity (92%), but conventional had very low sensitivity (52%) compared to PET/CT (97%). It means that almost every second neuroendocrine tumor detected by contemporary method cannot be discovered using conventional (classic) method. In metastatic pheochromocytoma detection contemporary (PET/ CT) methods (18F-DOPA and 18F-DA) have higher sensitivity than conventional (131I/123I-MIBG). In medullary thyroid carcinoma diagnostics contemporary method ([18F-DOPA) is more sensitive than conventional 99mTc(V)-DMSA method, and is similar to 18FDG, computed tomography and magnetic resonance. In carcinoid detection contemporary method (18F-DOPA) shows similar results with contemporary somatostatin receptor detection, while for gastroenteropancreatic neuroendocrine tumors it is worse. To conclude, contemporary (PET/CT) methods for somatostatin receptor detection (68Ga-DOTATOC/-NOC/-TATE) in neuroendocrine tumors are much more sensitive (almost twice) and more accurate than conventional. Therefore the classical methods should be urgently replaced by contemporary methods.