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

Browse trials for

• Neoplasms 9,365
• Neuroendocrine Tumors 676

Keywords

• PET/CT
• norepinephrine transporter imaging
• 18F-MFBG

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 6 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Study arms

• 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.

  Drug: (18F)MFBG · Device: PET/CT · Other: Venous blood samples

Interventions

• Drug(18F)MFBG

  One intravenous injection of 4 MBq/kg (adults) One intravenous injection of 2 MBq/kg (minor participants)

  Also known as: 18F-MFBG

• DevicePET/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.

• OtherVenous 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).

Primary outcomes

1. Confirmation of 18F-MFBG as a hNET imaging agent in patients with neural crest and neuroendocrine tumors.

   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.

   Time frame: 20 months

Secondary outcomes

1. Normal-organ and tumor uptake of 18F-MFBG as a function of time

   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.

   Time frame: 20 months

2. Identify the ideal time point for imaging after 18F-MFBG injection.

   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.

   Time frame: 20 months

3. Safety analysis of 18F-MFBG administration: Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

   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.

   Time frame: 20 months

4. Assessment of lesion targeting by 18F-MFBG as compared to 123I-MIBG

   A lesion-by-lesion analysis (visual and semi-quantitative) will be performed to compare the number of detected lesions using both tracers.

   Time frame: 20 months

Publications

• Pauwels E, Celen S, Vandamme M, Leysen W, Baete K, Bechter O, Bex M, Serdons K, Van Laere K, Bormans G, Deroose CM. Improved resolution and sensitivity of [18F]MFBG PET compared with [123I]MIBG SPECT in a patient with a norepinephrine transporter-expressing tumour. Eur J Nucl Med Mol Imaging. 2021 Jan;48(1):313-315. doi: 10.1007/s00259-020-04830-x. Epub 2020 May 8. No abstract available. PubMed 32385645 ↗

Individual participant data

Plan to share: No