This study has been transitioned to CTIS with ID 2024-513622-35-00 check the CTIS register for the current data. The primary objective of this study is to assess the number of detected pheochromocytoma lesions, proved by histology, with [18F]mFBG…
ID
Source
Brief title
Condition
- Adrenal gland disorders
- Endocrine neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The number of detected pheochromocytoma lesions, proved by histology, with
pathological [18F]mFBG uptake, defined as focal uptake above surrounding normal
tissue, compared to number of lesions detected on protocollary conventional CT
imaging prior to surgery.
Secondary outcome
1) Optimal time point of [18F]mFBG PET-CT imaging via comparison of SUV values
at 1 and 2 hours on PET-CT imaging.
2) Correlation of [18F]mFBG PET findings with pathology and
immunohistochemistry analysis of norepinephrine transporter.
3) Estimation of radiation dose of [18F]mFBG in normal tissues using dynamic
PATLAK imaging
4) Safety analysis of [18F]mFBG administration on clinical symptoms will be
evaluated by Adverse Events outcomes
Background summary
Pheochromocytomas are rare neuroendocrine tumors with a high variability in
clinical presentation. In current diagnostics, a CT is recommended as the first
screening modality. Next step in diagnostics was earlier a [123I]mIBG scan, but
this technique has drawbacks, namely a relatively low resolution due to gamma
camera imaging, long acquisition times, necessary protection for the thyroid
gland and a two-day scan protocol. [18F]mFBG is a new radionuclide tracer
(similar to [123I]mIBG), but with the advantages of higher resolution, no
necessary thyroid protection and a one-day scanning protocol. We want to
compare this new [18F] mFBG PET-CT tracer with CT. In case of good accuracy in
detecting pheochromocytomas, [18F]mFBG could also be used for paragangliomas.
This is important because paragangliomas are often missed during screening.
Study objective
This study has been transitioned to CTIS with ID 2024-513622-35-00 check the CTIS register for the current data.
The primary objective of this study is to assess the number of detected
pheochromocytoma lesions, proved by histology, with [18F]mFBG PET-CT compared
to the conventional CT.
Study design
Phase 2 imaging study
Study burden and risks
Patients will undergo an additional [18F]mFBG PET-CT. The extra expected
radiation dose is 9.6mSv, which is comparable to the radiation exposure one
receives on 4-yearly basis in nature. The time burden for this study is maximal
3 hours, which can be seen as a low burden. The information obtained with
[18F]mFBG PET-CT will be discussed in the weekly neuroendocrine
multidisciplinary tumour board and used in clinical decision making. [18F]mFBG
PET-CT may provide helpful information and may detect additional metastases or
paraganglioma locations that might have clinical consequences. Also PET imaging
might detect disease more accurately, leading to better tailored surgical
and/or radiation therapy treatments.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- The patient has provided written informed consent authorization before
participating in the study.
- The patient is >=18 years of age at the time of consent.
- The patient has a diagnosis of pheochromocytoma with a known anatomical
location or laboratory findings suspicious for pheochromocytoma defined as
elevated serum/plasma metanefrines.
- The patient should have surgery planned.
- The patient should have had a CT scan not older than 8 weeks at time of the
[18F]mFBG PET-CT..
- The patient has an ECOG status of Grade 0 - 2.
Exclusion criteria
- Patient is mentally or legally incapacitated.
- Patient is pregnant or lactating.
- Patient has active serious infections not controlled by antibiotics.
- Patient is unable or unwilling to undergo PET-CT scanning or surgery.
- Patient did receive interfering treatment between conventional CT scanning
and [18F]mFBG PET-CT.
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-513622-35-00 |
| EudraCT | EUCTR2020-005157-24-NL |
| CCMO | NL75688.041.21 |