18F-MFBG PET Imaging of the Norepinephrine Transporter in Neural Crest and Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT04258592|
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : February 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neural Crest Tumor Neuroendocrine Tumors||Drug: (18F)MFBG Device: PET/CT Other: Venous blood samples||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||18F-MFBG PET Imaging of the Norepinephrine Transporter in Neural Crest and Neuroendocrine Tumors: a Phase I PET/CT Study|
|Actual Study Start Date :||February 7, 2020|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||August 1, 2021|
A single dose of 18F-MFBG will be intravenously injected in 10 patients with neural crest tumors or neuroendocrine tumors. 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.
One intravenous injection of 4 MBq/kg
Other Name: 18F-MFBG
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.
Other: Venous blood samples
Blood samples will be obtained for laboratory safety evaluation for initial screening and safety evaluation after injection. Furthermore, 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, 120 ± 60 min).
- Confirmation of 18F-MFBG as a hNET imaging agent in patients with neural crest and neuroendocrine tumors. [ Time Frame: 20 months ]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.
- Normal-organ and tumor uptake of 18F-MFBG as a function of time [ Time Frame: 20 months ]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.
- Identify the ideal time point for imaging after 18F-MFBG injection. [ Time Frame: 20 months ]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.
- Safety analysis of 18F-MFBG administration: Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [ Time Frame: 20 months ]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.
- Assessment of lesion targeting by 18F-MFBG as compared to 123I-MIBG [ Time Frame: 20 months ]A lesion-by-lesion analysis (visual and semi-quantitative) will be performed to compare the number of detected lesions using both tracers.
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): NCT04258592
|Contact: Christophe Deroose, MD, PhD||+32 16 firstname.lastname@example.org|
|Universitaire Ziekenhuizen Leuven||Recruiting|
|Leuven, Belgium, 3000|
|Contact: Christophe Deroose, MD, PhD|
|Principal Investigator:||Christophe Deroose, MD, PhD||Universitaire Ziekenhuizen Leuven|