- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04258592
18F-MFBG PET Imaging of the Norepinephrine Transporter in Neural Crest and Neuroendocrine Tumors
August 9, 2022 updated by: Universitaire Ziekenhuizen KU Leuven
18F-MFBG PET Imaging of the Norepinephrine Transporter in Neural Crest and Neuroendocrine Tumors: a Phase I PET/CT Study
The aim of this study is to evaluate the potential and feasibility of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) in patients with neural crest and neuroendocrine tumors.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Ten neural crest tumor or neuroendocrine tumor (NET) patients, with a routine clinical 123I-metaiodobenzylguanidine (123I-MIBG imaging) (planar + single photon emission tomography (SPECT)) performed in the previous six months or scheduled within three months, will undergo a dynamic PET scan for the first 30 minutes, followed by 3 static whole-body PET/CTs up to three hours post injection for a pharmacokinetics study and efficacy assessment of 18F-MFBG in humans.
Furthermore, a comparison with 123I-MIBG imaging will be performed.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Leuven, Belgium, 3000
- Universitaire Ziekenhuizen Leuven
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 months and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is aged 1 year or older
- Signed Informed Consent by the participant (adult) or his/her parents or legal guardian (minors)
- Subject is diagnosed with a neural crest tumor or neuroendocrine tumor
- Subject is judged to be in good general condition by the investigator on the basis of medical history, physical examination including vital signs and clinical laboratory tests, besides the diagnosis of a neural crest tumor
- Subject should have a routine clinical 123I-MIBG scintigraphy (planar + SPECT/CT) performed within 6 months prior to the inclusion visit or scheduled within 3 months after the inclusion visit
- Adult female subjects should be post-menopausal or surgically sterile or using effective contraceptive with negative pregnancy test. Minor female participants of childbearing potential that are sexually active should be using effective contraceptive with negative pregnancy test
Exclusion Criteria:
- Subject has a previous or ongoing recurrent or chronic disease, other than a neural crest tumor, at high risk to interfere with the evaluation of the trial according to the judgement of the investigator, e.g. known gastro-intestinal, hepatic, renal, cardiovascular, metabolic or hormonal disease, cancer, major neurological or convulsive disorder or any psychiatric disease
- Subject is currently, or within two weeks prior to the inclusion visit, a user (including ''recreational use'') of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse
- Subject is unable to refrain from smoking more than 10 cigarettes per day during the study
- Subject has had exposure to ionizing radiation (> 1 mSv) in other research studies within the last 12 months
- Subject suffers from claustrophobia or cannot tolerate confinement during PET/CT scanning procedures
- Adult subject cannot lie still for 45 minutes inside the scanner. Minor participant cannot lie still for the duration of at least one whole-body PET/CT, varying from 15 to 30 minutes depending on the length of the child, except for children who will be sedated for one scan
- Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e. weight lifting, running, bicycling) from the time of the selection visit until the final safety telephone follow-up interview
- Subject or his/her parents or legal guardian in case of minors, does not understand the study procedure
- Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator.
- Subject is potentially pregnant (serum and urinary hCG test will be performed in women where pregnancy is not excluded) or is breast-feeding
- Subject has recently (< 30 days or 5 times the plasma half-life of the investigated drug, whichever is longest) participated or is simultaneously participating in another prospective interventional clinical trial
- Subject has a history of multiple and/or severe allergies to drugs or food
- Subject underwent surgery between the selection and inclusion visit
- Adult subject is mentally or legally incapacitated
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients
A single dose of 18F-MFBG will be intravenously injected in 10 patients with neural crest tumors or neuroendocrine tumors.
Adult patients will first undergo a dynamic PET scan, followed by whole-body PET/CT scans at various time points for a pharmacokinetics study and efficacy assessment.
Pediatric patients will undergo, depending on what is feasible for the child, at least 1 and up to 2 static whole-body PET/CTs.
In patients 12 years or older, also a dynamic PET scan can be performed.
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One intravenous injection of 4 MBq/kg (adults) One intravenous injection of 2 MBq/kg (minor participants)
Other Names:
Adult patients will undergo a dynamic PET scan for the first 30 minutes, followed by 3 static whole-body PET/CTs at 60 ± 10 min, 120 ± 30 min and 180 ± 30 min post injection.
Pediatric patients will undergo, depending on what is feasible for the child, at least 1 and up to 2 static whole-body PET/CTs.
In patients 12 years or older, also a dynamic PET scan can be performed.
Blood samples will be obtained for laboratory safety evaluation for initial screening and safety evaluation after injection.
Furthermore, in patients undergoing a dynamic PET scan venous blood samples will be obtained for metabolite analysis and activity measurements at various time points post injection (5 ± 2 min, 10 ± 5 min, 20 ± 10 min, 40 ± 20 min, 60 ± 30 min and 120 ± 60 min in adult participants; 5 ± 2 min, 10 ± 5 min, 30 ± 15 min, 50 ± 25 min, 90 ± 30 min in minor participants).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confirmation of 18F-MFBG as a hNET imaging agent in patients with neural crest and neuroendocrine tumors.
Time Frame: 20 months
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The primary endpoint will be met if in 8 out of 10 patients, at least 80% of the known positive lesions on 123I-MIBG imaging is visualized.
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20 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Normal-organ and tumor uptake of 18F-MFBG as a function of time
Time Frame: 20 months
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Patients will undergo dynamic PET scanning followed by three static whole-body PET/CT scans at different time points post injection.
Uptake as a function of time (pharmacokinetics) will be studied using the software package PMOD (PMOD technologies LLC, Zürich, Switzerland).
Volumes of interest (VOIs) will be delineated in relevant normal organs and tumor lesions on all PET images and standardized uptake values (SUV) in all these VOIs will be measured to compute normal-organ and tumor uptake as a function of time.
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20 months
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Identify the ideal time point for imaging after 18F-MFBG injection.
Time Frame: 20 months
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Tumor-to-background ratios as a function of time will be measured.
The time point resulting in optimal tumor-to-background ratios, taking into account a realistic implementation in clinical practice, will be defined as the ideal time point for imaging.
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20 months
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Safety analysis of 18F-MFBG administration: Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time Frame: 20 months
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The impact of 18F-MFBG administration on clinical symptoms and signs and biochemistry values will be evaluated.
Baseline values will be recorded and subjects will be assessed clinically and with serial biochemical analysis.
Adverse events will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
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20 months
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Assessment of lesion targeting by 18F-MFBG as compared to 123I-MIBG
Time Frame: 20 months
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A lesion-by-lesion analysis (visual and semi-quantitative) will be performed to compare the number of detected lesions using both tracers.
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20 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 7, 2020
Primary Completion (Actual)
July 7, 2022
Study Completion (Actual)
July 7, 2022
Study Registration Dates
First Submitted
February 3, 2020
First Submitted That Met QC Criteria
February 3, 2020
First Posted (Actual)
February 6, 2020
Study Record Updates
Last Update Posted (Actual)
August 12, 2022
Last Update Submitted That Met QC Criteria
August 9, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S63142
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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