The aim of this pilot study is to investigate which PET tracer (FDG or FLT) is best suited for early PET diagnosis of transformation in patients with low grade NHL
ID
Source
Brief title
Condition
- Lymphomas non-Hodgkin's B-cell
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. detection rate (number of true positive PET lesions for either tracer, using
CT as reference test)
2. relative tracer uptake (SUV) for either tracer (lesion by lesion analysis,
lesion with highest uptake of FDG or FLT)
3. lowest and highest SUV for either tracer within one patient.
Secondary outcome
not applicable.
Background summary
The survival of patients with histological transformation might be better as
treatment is started when there is still limited disease (2), creating a need
for a non-invasive technique to diagnose the process of transformation early.
PET scanning can be this technique, but it is not clear yet, which PET tracer;
FDG or FLT, can distinguish better between indolent and transformed lymphoma.
The tracer that distinguishes best could then be used in a follow-up study to
analyze whether increasing uptake of the tracer in the same patient indicates
histologic transformation.
Study objective
The aim of this pilot study is to investigate which PET tracer (FDG or FLT) is
best suited for early PET diagnosis of transformation in patients with low
grade NHL
Study design
The design of the study is a pilot study with patients with newly diagnosed
follicular lymphoma or histologic transformation. In each patient a PET scan
will be made with both FDG and FLT as a tracer. It is a prospective
observational study using head-to-head comparison of FLT and FDG in consecutive
eligible patients with follicular and transformed lymphoma. Considering the
small series in literature we expect that after including 17 patients in each
group (follicular/transformed) we can determine which PET tracer is best in
distinguishing indolent from transformed lymphoma.
Study burden and risks
PET-CT: 1,2+3,5+3,5=8,2 mSv for both scans including CT. PET scans will be
performed minimally 1 day, maximally 7 days apart, in random order.
De Boelelaan 1117
1081 HV Amsterdam
Nederland
De Boelelaan 1117
1081 HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Inclusion criteria
1. Patients with newly diagnosed follicular lymphoma or newly diagnosed histological transformation of follicular lymphoma proven by histological examination.
2. Ann Arbor stage at diagnosis: II, III or IV.
3. at least one lesion > 2 cm diameter
4. After the diagnosis and before performing both PET scans they have not received any treatment.
5. Ability to remain supine for 60 min. (PET)
6. Written informed consent.
Exclusion criteria
Exclusion criteria
1. Uncontrolled diabetes mellitus.
2. Physical inability to access PET facilities.
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 | NL24544.029.08 |