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

NCT04258592 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-08-12

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Christophe Deroose, MD, PhD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-07
Primary Completion
2022-07-07
Completion
2022-07-07

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04258592 on ClinicalTrials.gov