This investigation aims to test a new, better and faster method voor measurement of the LVEF, that does not depend on technetium. The method relies on the tracer Gallium-citrate, a well-known molecule that is available in unlimited quantities in-…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility of the EF-PET technique, yes or no.
Secondary outcome
To optimize the procedure
To compare the technique with the current standard of planar LVEF measurement.
Background summary
Seriale quantitative evaluation van de left ventricular ejection fraction
(LVEF) is the corner stone of early detection of developing myocardial damage
during cardiotoxic chemotherapy. The LVEF is measured routinely using
technetium-99m based tracers and planar gammacamera imaging. This technique has
a number of disadvantages, such as quantification problems due to
overprojection, interobserver variation due to manual delineation, en
potentially Technetium shortages in the coming years.
Study objective
This investigation aims to test a new, better and faster method voor
measurement of the LVEF, that does not depend on technetium. The method relies
on the tracer Gallium-citrate, a well-known molecule that is available in
unlimited quantities in-house, and on the PET/CT camera that provides
3-dimensional images without overprojection. If the technical feasibility can
be demonstrated, a subsequent study on a larger scale can be performed to
validate the technique, to safeguard and improve the monitoring of the LVEF in
patients using cardiotoxic chemotherapy in the future.
Study design
Twenty patients will be measured twice, with the old and the new technique, on
the same day after each other. The outcomes of the measurements will be
compared using different criteria:
- Visual evaluation of the image quality
- The duration of the procedure (minutes)
- Estimated radiation burden for patients (mSv, based on dose)
- Estimated radiation burden for operating personnel (mSv, measured)
- The LVEF (calculated)
- Interobserver variability in image evaluation (3 blinded operators)
If the outcomes of all parameters are about equal or better than the old
method, the technique will be considered feasible, and a larger validation
study will be proposed.
Study burden and risks
Longer stay in the department of nucleaire geneeskunde for a maximum of several
hours extra (after the normal routine investigation). Intravenous
administration of a (known to be safe and registered) radioactive tracer,
followed by a PET with lowdose CT scan, for a total radiation exposure of 3 mSv
at maximum .
Plesmanlaan 121
1066 CX
NL
Plesmanlaan 121
1066 CX
NL
Listed location countries
Age
Inclusion criteria
- Patients with malignant disease of any kind
- Referred for LVEF measurement according to clinical indications
- Willing to undergo additional EF-PET on the same day
- Signed informed consent
Exclusion criteria
- Age < 18 years
- Pregnancy or laction
- Incapacitated subjects
- Arrythmia (e.g. atrial fibrillation)
Design
Recruitment
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 |
|---|---|
| CCMO | NL32006.031.10 |