The primary objective is to compare18F-MFBG PET-CT imaging for neuroblastoma patients with the current standard of imaging, 123I-MIBG SPECT, using the SIOPEN score for skeletal lesions and the number of detected soft tissue lesions as endpoints.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study endpoints are the number of lesions and sites of disease
detected with 18F-mFBG PET-CT compared to the current imaging standard of care,
123I-mIBG scan using the SIOPEN imaging scoring method for skeletal lesions and
the total number of detected soft tissue lesions
Secondary outcome
o Determine optimum imaging time of 18F-mFBG PET CT(60 min vs 120-150 min post
injection)
o Determine the estimation of radiation absorbed dose of 18F-mFBG
o Adverse events of 18F-mFBG injection and PET CT s
Background summary
123I-mIBG imaging is considered the best imaging modality in patients with
neuroblastoma, however, the radioactive tracer and imaging technique (planar
scintigraphy and SPECT) have several disadvantages:
* image acquisition takes a long time (+/- 2 hours)
* imaging requires two hospital visits as scanning is performed 24 hours after
administration of the radioactive tracer
* false-negative scans are seen in patients because of the limited resolution
of SPECT and planar scintigraphy images
* patients need medication to protect thyroid irradiation by 123I
These disadvantages might be overcome with 18F-mFBG, a slightly different
radioactive tracer that can be visualised by PET-CT, which has a superior
anatomical imaging capacity.
In this pilot study, the feasibility, safety and diagnostic accuracy of
18F-mFBG PET-CT will be assessed in 20 patients and compare with the 123I-mIBG
imaging.
Study objective
The primary objective is to compare18F-MFBG PET-CT imaging for neuroblastoma
patients with the current standard of imaging, 123I-MIBG SPECT, using the
SIOPEN score for skeletal lesions and the number of detected soft tissue
lesions as endpoints.
Study design
A prospective explorative diagnostic pilot-study. In this study the accuracy of
18F-mFBG PET in the detection of neuroblastoma sites will be investigated,
compared to the current imaging standard with 123I-mIBG scanning in 20
patients.
Intervention
na
Study burden and risks
Possible radiation exposure of extra scan.
Duration of the dynamic scan.
Possible side effects of the 18F-mFBG tracer
Heidelberglaan 25
Utrecht 3584 CS
NL
Heidelberglaan 25
Utrecht 3584 CS
NL
Listed location countries
Age
Inclusion criteria
- Patients with a (clinical suspicion of) neuroblastoma who are refferred for
conventional [123I]mIBG imaging.
- age between 0-18 years old.
- written informed consent from patients and/or from parents or legal
guardians, according to local law and regulations.
Exclusion criteria
Pregnancy of the patient
Age > 18 years
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-003713-33-NL |
| CCMO | NL70903.041.19 |
| OMON | NL-OMON28070 |