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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04258592
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Neural Crest Tumor Neuroendocrine Tumors Drug: (18F)MFBG Device: PET/CT Other: Venous blood samples Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
Experimental: Patients
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.
Drug: (18F)MFBG
One intravenous injection of 4 MBq/kg
Other Name: 18F-MFBG

Device: PET/CT
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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is aged 18 years or older
  • Signed Informed Consent
  • 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
  • Subject should have a routine clinical 123I-MIBG scintigraphy (planar + SPECT/CT) performed within 6 months prior to the inclusion visit or scheduled within 3 months after the inclusion visit
  • Female subjects should be post-menopausal or surgically sterile or using effective contraceptive with negative pregnancy test

Exclusion Criteria:

  • 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 currently, or within two weeks prior to the inclusion visit, a user (including ''recreational use'') of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse
  • 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; subject cannot lie still for 60 minutes inside the scanner
  • 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 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
  • Subject underwent surgery between the selection and inclusion visit
  • Subject is mentally or legally incapacitated

Information from the National Library of Medicine

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


Contacts
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Contact: Christophe Deroose, MD, PhD +32 16 343715 christophe.deroose@uzleuven.be

Locations
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Belgium
Universitaire Ziekenhuizen Leuven Recruiting
Leuven, Belgium, 3000
Contact: Christophe Deroose, MD, PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Christophe Deroose, MD, PhD Universitaire Ziekenhuizen Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04258592    
Other Study ID Numbers: S63142
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
PET/CT
norepinephrine transporter imaging
18F-MFBG
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue