|- candidate number||4211|
|- NTR Number||NTR1487|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-okt-2008|
|- Secondary IDs||2008/191 METC VUmc |
|- Public Title||Positron Emission Tomography for detection of histologic transformation of indolent non-Hodgkin’s lymphoma: a pilot study|
|- Scientific Title||Positron Emission Tomography for detection of histologic transformation of indolent non-Hodgkin’s lymphoma: a pilot study|
|- hypothesis||The survival of patients with histological transformation might be better as treatment is started when there is still limited disease. PET-scanning can be used to to diagnose the process of transformation early. But it is not clear yet, which tracer, FLT or FDG, is better in distinguishing indolent lymphoma from histological transformation. |
|- Healt Condition(s) or Problem(s) studied||Non Hodkin's lymfoma (NHL), Positron Emission Tomography (PET)|
|- 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||1. Uncontrolled diabetes mellitus. |
2. Physical inability to access PET facilities.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||15-okt-2008|
|- planned closingdate||15-okt-2009|
|- Target number of participants||34|
|- Interventions||Patients will receive two PET-scans: one with FDG tracer and one with FLT tracer.|
After the diagnosis and before performing both PET-scans, patients have not received any treatment. PET-scans will be performed minimally one day, maximally 7 days apart, in random order.
|- Primary outcome||- Maximal Standard Uptake Value (SUVmax), SUV mean and intraindividual variability|
|- Secondary outcome||N/A|
|- Timepoints||- At entry|
- After performing both PET-scans
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Mw. Drs. M.J. Wondergem|
|- CONTACT for SCIENTIFIC QUERIES||Mw. Drs. M.J. Wondergem|
|- Sponsor/Initiator ||VU University Medical Center, Department of Hematology|
(Source(s) of Monetary or Material Support)
|VU University Medical Center, Department of Hematology|
|- Brief summary||A pilot study 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: a prospective observational study. Patient population: patients with newly diagnosed follicular lymphoma and patients with newly diagnosed histological transformation of follicular lymphoma.|
|- Main changes (audit trail)|
|- RECORD||9-okt-2008 - 19-okt-2008|