Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT06233903
Eligibility Criteria:
Inclusion Criteria:
I. Neuroblastoma subjects (Cohort I)
1. The subject has an established diagnosis of neuroblastoma based on unequivocal histopathology from tissue obtained at any time prior to enrollment in the trial.
2. Functional imaging (123I-mIBG or 18F-FDG) studies performed within 60 days prior to receiving investigational drug in the trial are available for retrieval and independent review.
3. The subject is scheduled to undergo an invasive procedure (surgery or biopsy) for diagnosis or therapy of neuroblastoma within 21 days after receiving investigational drug in the trial, with no therapy in the interval between 18F-mFBG imaging and surgery/biopsy.
4. Histology specimens from the biopsy or surgical procedure are expected to be available and suitable for NET expression analyses.
II. Non-neuroblastoma subjects (Cohort II):
5. The subject is scheduled to undergo an invasive procedure (surgery or biopsy) to obtain tissue from an adrenergically-innervated organ or a neural crest tumor within 21 days after 18F-mFBG imaging.
6. Histology specimens from the biopsy or surgical procedure are expected to be available and suitable for NET expression analyses.
III. All subjects:
7. The subject is able and willing to comply with study procedures and a signed and dated informed consent (supplemented by signed and dated assent from subjects age 7-17) is obtained from the subject and/or at least 1 parent/guardian.
Exclusion Criteria:
Study Population
\- The population will consist of either: subjects with histopathologically confirmed diagnosis of neuroblastoma; or subjects with a clinical indication for biopsy or surgical sampling of an adrenergically-innervated organ or a non-neuroblastoma neural crest tumor.
Inclusion Criteria:
Subjects will be eligible for participation in the study only if they meet ALL of the following criteria:
I. Neuroblastoma subjects (Cohort I)
1. The subject has an established diagnosis of neuroblastoma based on unequivocal histopathology from tissue obtained at any time prior to enrollment in the trial.
2. Functional imaging (123I-mIBG or 18F-FDG) studies performed within 60 days prior to receiving investigational drug in the trial are available for retrieval and independent review.
3. The subject is scheduled to undergo an invasive procedure (surgery or biopsy) for diagnosis or therapy of neuroblastoma within 21 days after receiving investigational drug in the trial, with no therapy in the interval between 18F-mFBG imaging and surgery/biopsy.
4. Histology specimens from the biopsy or surgical procedure are expected to be available and suitable for NET expression analyses.
II. Non-neuroblastoma subjects (Cohort II)
5. The subject is scheduled to undergo an invasive procedure (surgery or biopsy) to obtain tissue from an adrenergically-innervated organ or a neural crest tumor within 21 days after 18F-mFBG imaging.
6. Histology specimens from the biopsy or surgical procedure are expected to be available and suitable for NET expression analyses.
III. All subjects
7. The subject is able and willing to comply with study procedures and a signed and dated informed consent (supplemented by signed and dated assent from subjects age 7-17) is obtained from the subject and/or at least 1 parent/guardian.
Exclusion Criteria:
Subjects will not be eligible for participation in the study if they meet ANY of the following criteria:
1. Previously enrolled in this study.
2. Unable to lie flat or remain still for approximately 30 minutes to allow performance of a PET scan.
3. The subject has a history or suspicion of significant allergic reaction or anaphylaxis to any components of the 18F-mFBG imaging agent.
4. The subject is pregnant, breast feeding, or menarchal and unwilling to use effective contraception during the study.
5. Uses medications that are known to interfere with uptake of NET-dependent agents
(e.g., certain antidepressants and sympathomimetics) and these medications cannot be safely withheld 24 hours before study procedures.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06233903
Study Brief:
Protocol Section:
NCT06233903