Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286832
Status:
COMPLETED
Last Update Posted:
2011-07-06
First Post:
2006-02-03
Brief Title:
Early On-therapy PET at First-line Treatment in Diffuse Large B-cell Lymphoma Stage IIB-IV
Sponsor:
Copenhagen University Hospital at Herlev
Organization:
Copenhagen University Hospital at Herlev
Study Overview
Official Title:
Evaluation of Response to Treatment Using 18F-FDG Positron Emission Tomography Imaging PET With Special Emphasize on the Prognostic Significance of Early On-therapy PET at First-line Treatment in Diffuse Large B-cell Lymphoma Stage IIB-IV
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Early identification of refractory lymphoma patients provides a basis for stratification between responders to standard approaches and non-responders who may benefit from an early change to an alternative treatment strategyMetabolic or molecular imaging with fluorine-18 fluorodeoxyglucose positron emission tomography 18F-FDG-PET has emerged as a powerful imaging modality for diagnosis staging and therapy monitoring of a variety of cancers The primary hypothesis of the present study is that early response can be pinpointed by PET reflecting both tumor burden and activity as a surrogate for final outcome An increasing number of studies have suggested the potential role of 18F-FDG PET in the staging and monitoring of lymphomas The optimal timing of PET scans and the potential role of quantitative PET using SUV to assess response to chemotherapy remain to be defined Confirmation of very early 18F-FDG-PET as a significant predictor of treatment response in a homogenous group of aggressive lymphoma patients would potentially change the prognosis of the patient by allowing earlier use of alternative therapies and discontinuation of therapy that will not lead to a significant tumour response
Detailed Description:
Title Evaluation of response to treatment using 18F-FDG positron emission tomography imaging PET in diffuse large B-cell lymphoma stage IIB-IV with special emphasize on the prognostic significance of early on-therapy PET at first-line treatment
Study design Multicenter trial
Planned sample size 100 patients
Number of centers Denmark 2 Sweden 1 Norway 1 Finland 1
Aim of the study 1 To evaluate the prognostic significance of PET early after treatment initiation 2 To compare early PET with standard response criteria for NHL and the International Prognostic Index IPI in the prediction of response and outcome
Primary objective The prognostic significance of FDG-PET after 1 cycle of chemotherapy
End-points Progression-free survival PFS Overall survival OS Response to treatment standardized response criteria at mid-treatment and post-treatment
Inclusion criteria
Age 18 years Newly diagnosed consecutive patients with diffuse large B-cell lymphoma DLBCL according to the WHO classification
Ann Arbor stage IIB-IV Written informed consent
Exclusion criteria Previously treated with chemotherapy or irradiation Previous malignant diagnosis except basal cell carcinoma and cervical carcinoma in situ
Pregnancy Lactation Diabetes mellitus Extreme adipositas Claustrophobia Active inflammatory disease or infection
PET-CT evaluation PET and CT at primary staging before initiation of therapy and PET after one cycle of intravenous chemotherapy day 10-20 are mandatory The results of the PET scans are blinded and will not be available for the local physicians If the PET result is opened the patient will be excluded from the study
Only post-treatment PET scans are allowed outside the protocol The local physician may use post-treatment PET in diagnostic or therapeutic considerations
Only dedicated full-ring PET scanners are allowed in this study
Treatment Therapy with a CHOP-like backbone according to local standards of the individual centers Treatment according to other protocols allowed
Study design Multicenter trial
Planned sample size 100 patients
Number of centers Denmark 2 Sweden 1 Norway 1 Finland 1
Aim of the study 1 To evaluate the prognostic significance of PET early after treatment initiation 2 To compare early PET with standard response criteria for NHL and the International Prognostic Index IPI in the prediction of response and outcome
Primary objective The prognostic significance of FDG-PET after 1 cycle of chemotherapy
End-points Progression-free survival PFS Overall survival OS Response to treatment standardized response criteria at mid-treatment and post-treatment
Inclusion criteria
Age 18 years Newly diagnosed consecutive patients with diffuse large B-cell lymphoma DLBCL according to the WHO classification
Ann Arbor stage IIB-IV Written informed consent
Exclusion criteria Previously treated with chemotherapy or irradiation Previous malignant diagnosis except basal cell carcinoma and cervical carcinoma in situ
Pregnancy Lactation Diabetes mellitus Extreme adipositas Claustrophobia Active inflammatory disease or infection
PET-CT evaluation PET and CT at primary staging before initiation of therapy and PET after one cycle of intravenous chemotherapy day 10-20 are mandatory The results of the PET scans are blinded and will not be available for the local physicians If the PET result is opened the patient will be excluded from the study
Only post-treatment PET scans are allowed outside the protocol The local physician may use post-treatment PET in diagnostic or therapeutic considerations
Only dedicated full-ring PET scanners are allowed in this study
Treatment Therapy with a CHOP-like backbone according to local standards of the individual centers Treatment according to other protocols allowed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None