orepinephrine transporter PET imaging in neural crest and neuroendocrine tumors using a new fluorine-18 based norepinephrine transporter tracer (18F-MFBG): a phase I PET/CT study
- Conditions
- eural crest tumors and neuroendocrine tumorsTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-003872-37-BE
- Lead Sponsor
- niversity Hospitals Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
- Age 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.
- 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.
- 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 4
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
- 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
- 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 guardion 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 of childbearing potential) 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
- Adult subject is mentally or legally incapacitated
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate the potential of 18F-MFBG as a PET hNET imaging agent in patients with neural crest and neuroendocrine tumors;Secondary Objective: - Perform a pharmacokinetic assessment of 18F-MFBG in humans.<br>- Identify the ideal time point for imaging after 18F-MFGB injection.<br>- Evaluate the safety and clinical tolerance of administration of 18F-MFBG.<br>- Perform a preliminary assessment of lesion targeting by 18F-MFBG as compared to 123I-MIBG in patients with neural crest and neuroendocrine tumors.;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: After the PET/CT scans of 10 patients.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Pharmacokinetic assessment of 18F-MFBG in humans<br>2. Identification of the ideal time point for imaging after 18F-MFBG injection<br>3. Safety evaluation of administration of 18F-MFBG<br>4. Lesion-by-lesion analysis of the number of detected lesions with 18F-MFBG as compared to 123I-MIBG in patients with neural crest or neuroencorine tumors;Timepoint(s) of evaluation of this end point: 1. After the PET/CT scans of the 10 patients<br>2. After the PET/CT scans of the 10 patients<br>3. After the last safety telephone follow-up interview of the last subject undergoing the trial<br>4. After the PET/CT scans of the 10 patients