To demonstrate the accuracy of FLT-PET to be an early response parameter for haematological recovery.
ID
Source
Brief title
Condition
- Haematological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-To define the uptake of 18F-FLT in the bone marrow compartment 12-14 days
post-ASCT.
-Correlation of 18F-FLT uptake with short and long-term engraftment.
Secondary outcome
not applicable.
Background summary
18F-FLT is an important tool for demonstrating cycling activity of the
hematopoietic bone marrow compartment. In addition it provides the opportunity
to visualize the total bone marrow compartment in contrast to a bone marrow
biopsy. Since no parameters are available that are predictive for the speed of
haematological recovery post autologous stem cell transplantation (ASCT) we
questioned whether the uptake of 18F-FLT early post-ASCT might be an early
response parameter for haematological recovery.
Study objective
To demonstrate the accuracy of FLT-PET to be an early response parameter for
haematological recovery.
Study design
Pilot study in patients post-ASCT. 18F-FLT scan will be performed and compared
with the standard parameters of haematological recovery i.e. the time of
platelet and granulocyte recovery and transfusion independency.
Study burden and risks
-The radiation dose is 6.2 mSv for a patient of 80 kg. According to the RIVM
the annual background from natural radiation in the Netherlands is 2.5 mSv. No
adverse events are to be expected during the PET scanning.
-No additional investigations will be performed in the studied patient group.
- Visit to PET center and scan.
Hanzeplein 1
9713 GZ Groningen
Nederland
Hanzeplein 1
9713 GZ Groningen
Nederland
Listed location countries
Age
Inclusion criteria
- Patients following ASCT
- Patient > 18 years of age
Exclusion criteria
- Ineligible to perform a scan
- Age <18 years
- Severe kidney dysfunction; serum-creatinine >=250 µM
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 | NL27598.042.09 |