NCT04258592

18F-MFBG PET Imaging of the Norepinephrine Transporter in Neural Crest and Neuroendocrine Tumors

18F-MFBG PET Imaging of the Norepinephrine Transporter in Neural Crest and Neuroendocrine Tumors: a Phase I PET/CT Study

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Neural Crest Tumor
• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	(18F)MFBG	One intravenous injection of 4 MBq/kg (adults) One intravenous injection of 2 MBq/kg (minor participants)
DEVICE	PET/CT	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.
OTHER	Venous blood samples	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).

Timeline

• Start date: 2020-02-07
• Primary completion: 2022-07-07
• Completion: 2022-07-07
• First posted: 2020-02-06
• Last updated: 2022-08-12

Locations

1 site across 1 country: Belgium