Diffuse Large-Cell LymphomaNCT00286832
Early On-therapy PET at First-line Treatment in Diffuse Large B-cell Lymphoma Stage IIB-IV
An observational study of Diffuse Large-Cell Lymphoma, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial 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 strategy.Metabolic or molecular imaging with fluorine-18 fluorodeoxyglucose positron emission tomography… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large-Cell Lymphoma
- What is being tested?
- PET scan
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2005to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample according to the area covered by the participating centers
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Hematology, Odense University Hospital
Odense, 5000
About this study
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
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 strategy.Metabolic 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.
Read the 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.
- Conditions
- Diffuse Large-Cell Lymphoma
- Being tested
- PET scan
- Keywords
- Non-Hodgkin's lymphoma, Diffuse large B-cell lymphoma, PET, Prognosis
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET scanProcedure or surgery
Also called positron emission tomography
One extra PET scan after 1 cycle of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Single group study | Not described Receives: Procedure: PET scan |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startAug 2005
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large-Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Collaborators
- Nordic Lymphoma Group
- Investigators
- Lars M Pedersen, MD, Principal investigator, Nordic Lymphoma Group (Large Cell Group)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286832
- Sponsor's protocol ID
- NLG PET Study
- Status last verified
- Jul 2011
- First submitted
- 3 Feb 2006
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00286832
- Acronym / sponsor ID
- NLG PET Study
- Conditions
- Diffuse Large-Cell Lymphoma
- Keywords
- Non-Hodgkin's lymphoma, Diffuse large B-cell lymphoma, PET, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Collaborators
- Nordic Lymphoma Group
- Study start
- Aug 2005
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 strategy.Metabolic 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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group study | – | Procedure: PET scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample according to the area covered by the participating centers
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Previously treated with chemotherapy or irradiation.
- Previous malignant diagnosis except basal cell carcinoma and cervical carcinoma in situ.
- Pregnancy.
- Lactation.
- Diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET scanAlso: positron emission tomographyOne extra PET scan after 1 cycle of treatment. | Procedure or surgery | Single group study |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars M Pedersen, MD principal investigator
Nordic Lymphoma Group (Large Cell Group)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large-Cell Lymphoma, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2011.