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Positron Emission Tomography for detection of histologic transformation of indolent non-Hodgkin’s lymphoma: a pilot study


- candidate number4211
- NTR NumberNTR1487
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-okt-2008
- Secondary IDs2008/191 METC VUmc
- Public TitlePositron Emission Tomography for detection of histologic transformation of indolent non-Hodgkin’s lymphoma: a pilot study
- Scientific TitlePositron Emission Tomography for detection of histologic transformation of indolent non-Hodgkin’s lymphoma: a pilot study
- ACRONYMN/A
- hypothesisThe 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) studiedNon Hodkin's lymfoma (NHL), Positron Emission Tomography (PET)
- Inclusion criteria1. 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 criteria1. Uncontrolled diabetes mellitus.
2. Physical inability to access PET facilities.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 15-okt-2008
- planned closingdate15-okt-2009
- Target number of participants34
- InterventionsPatients 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 outcomeN/A
- Timepoints- At entry
- After performing both PET-scans
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMw. Drs. M.J. Wondergem
- CONTACT for SCIENTIFIC QUERIESMw. Drs. M.J. Wondergem
- Sponsor/Initiator VU University Medical Center, Department of Hematology
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center, Department of Hematology
- PublicationsN/A
- Brief summaryA 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)
- RECORD9-okt-2008 - 19-okt-2008


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