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

NCT04258592 | Terminated Phase 1

• 1 other identifier: S63142
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Neural Crest Tumor; Neuroendocrine Tumors

Keywords

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

Outcome Measures

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.

  20 months

Secondary Outcomes (4)

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

  20 months

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

  20 months

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

  20 months

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

  20 months

Study Arms (1)

Patients

EXPERIMENTAL

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

(18F)MFBG DRUG

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

Also known as: 18F-MFBG

Patients

PET/CT DEVICE

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.

Patients

Venous blood samples OTHER

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).

Patients

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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 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
• Adult subject is mentally or legally incapacitated

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

Related Publications (2)

• Pauwels E, Celen S, Baete K, Koole M, Bechter O, Bex M, Renard M, Clement PM, Jentjens S, Serdons K, Van Laere K, Bormans G, Deroose CM. [18F] MFBG PET imaging: biodistribution, pharmacokinetics, and comparison with [123I] MIBG in neural crest tumour patients. Eur J Nucl Med Mol Imaging. 2023 Mar;50(4):1134-1145. doi: 10.1007/s00259-022-06046-7. Epub 2022 Nov 26.

  PMID: 36435928 DERIVED

• 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.

  PMID: 32385645 DERIVED

MeSH Terms

Conditions

Neural crest tumor; Neuroendocrine Tumors

Interventions

3-fluorobenzylguanidine; Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Christophe Deroose, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 6, 2020
• Study Start: February 7, 2020
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)