LymphomaNCT00712556
PET Study in Patients With Non-Hodgkin Lymphoma
An observational study of Lymphoma, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
Trial summary
RATIONALE: Diagnostic procedures, such as fluorine 18-fludeoxyglucose positron emission tomography (PET) scans, may help doctors predict a patient's response to treatment and help plan the best treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma
- What is being tested?
- fluorine 18-fludeoxyglucose positron emission tomography
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2008to Mar 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with non-Hodgkin lymphoma
Who may be able to join
- DISEASE CHARACTERISTICS:
- Diagnosis of non-Hodgkin lymphoma
- Has undergone high-dose chemotherapy followed by autologous stem cell transplantation at Vanderbilt University between March 1997 and August 2005
- Has undergone fluorine 18-fludeoxyglucose PET within 70 days prior to and/or at approximately 30 days and 100 days after high-dose chemotherapy and autologous stem cell transplantation
Who cannot join
- PATIENT CHARACTERISTICS:
- Not specified
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Positron Emission Tomography Study in Patients With Non-Hodgkin Lymphoma
RATIONALE: Diagnostic procedures, such as fluorine 18-fludeoxyglucose positron emission tomography (PET) scans, may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase I trial is studying fluorine 18-fludeoxyglucose PET scan to see how well it predicts outcomes in patients who have undergone high-dose chemotherapy and autologous stem cell transplant for non-Hodgkin lymphoma.
Read the detailed description
OBJECTIVES:
- To determine if a fluorine 18-fludeoxyglucose positron emission tomography scan, performed as early as day 30 after high-dose chemotherapy and autologous stem cell transplantation, may be useful in identifying patients with non-Hodgkin lymphoma who may benefit from early interventions, including reduced intensity stem cell transplantation or additional therapy, to preempt disease relapse and improve overall survival.
OUTLINE: Conventional imaging, biopsy, and clinical examination findings are reviewed to determine patient clinical outcome (e.g., complete remission, disease progression/relapse, or death related to the primary disease).
- Conditions
- Lymphoma
- Being tested
- fluorine 18-fludeoxyglucose positron emission tomography
- Keywords
- stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage III marginal zone lymphoma, stage III small lymphocytic lymphoma, stage IV adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma
- Medical subject headings
- Lymphoma, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Follicular, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorine 18-fludeoxyglucose positron emission tomographyRadiation
Also called fluorine 18-fludeoxyglucose PET
fluorine 18-fludeoxyglucose is a radioactive isotope used in PET to detect cancer tumors
| Study group | Role | What they receive |
|---|---|---|
| Flourine 18-fluorodeoxyglucose PET | PET using fluorine 18-fluorodeoxyglucose to image cancer tumors Receives: Radiation: fluorine 18-fludeoxyglucose positron emission tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of sensitivity, specificity, positive predictive value, and negative predictive value of fluorine 18-fludeoxyglucose positron emission tomography scan with with patients' clinical outcomes.
Measured: from the date of stem cell transplant to date of clinical disease progression or to date of last follow-up
Secondary outcomes (1)
Progression-free survival
Measured: from date of stem cell transplant to date of clinical disease progression or date of last follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adetola A. Kassim, Vanderbilt-Ingram Cancer Center
- Investigators
- Adetola A. Kassim, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712556
- Sponsor's protocol ID
- VICC BMT 0828
- Other IDs
- VU-VICC-BMT-0828, VU-VICC-080426
- Status last verified
- Feb 2013
- First submitted
- 9 Jul 2008
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography Study in Patients With Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT00712556
- Acronym / sponsor ID
- VICC BMT 0828
- Conditions
- Lymphoma
- Keywords
- stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 10 Jul 2008 (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.
RATIONALE: Diagnostic procedures, such as fluorine 18-fludeoxyglucose positron emission tomography (PET) scans, may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase I trial is studying fluorine 18-fludeoxyglucose PET scan to see how well it predicts outcomes in patients who have undergone high-dose chemotherapy and autologous stem cell transplant for non-Hodgkin lymphoma.
Detailed description
OBJECTIVES:
- To determine if a fluorine 18-fludeoxyglucose positron emission tomography scan, performed as early as day 30 after high-dose chemotherapy and autologous stem cell transplantation, may be useful in identifying patients with non-Hodgkin lymphoma who may benefit from early interventions, including reduced intensity stem cell transplantation or additional therapy, to preempt disease relapse and improve overall survival.
OUTLINE: Conventional imaging, biopsy, and clinical examination findings are reviewed to determine patient clinical outcome (e.g., complete remission, disease progression/relapse, or death related to the primary disease).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flourine 18-fluorodeoxyglucose PET | – | Radiation: fluorine 18-fludeoxyglucose positron emission tomographyPET using fluorine 18-fluorodeoxyglucose to image cancer tumors |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with non-Hodgkin lymphoma
Key inclusion criteria (4 listed)
- Diagnosis of non-Hodgkin lymphoma
- Has undergone high-dose chemotherapy followed by autologous stem cell transplantation at Vanderbilt University between March 1997 and August 2005
Key exclusion criteria (4 listed)
- Not specified
- See Disease Characteristics
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 |
|---|---|---|
| fluorine 18-fludeoxyglucose positron emission tomographyAlso: fluorine 18-fludeoxyglucose PETfluorine 18-fludeoxyglucose is a radioactive isotope used in PET to detect cancer tumors | Radiation | Flourine 18-fluorodeoxyglucose PET |
Primary outcome
Correlation of sensitivity, specificity, positive predictive value, and negative predictive value of fluorine 18-fludeoxyglucose positron emission tomography scan with with patients' clinical outcomes.
Time frame: from the date of stem cell transplant to date of clinical disease progression or to date of last follow-up
1 secondary outcome
Progression-free survival
Time frame: from date of stem cell transplant to date of clinical disease progression or date of last follow-up
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 26 Feb 2013.
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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.
Adetola A. Kassim, MD principal investigator
Vanderbilt-Ingram Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
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 4 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 26 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
What does the primary outcome measure?
Correlation of sensitivity, specificity, positive predictive value, and negative predictive value of fluorine 18-fludeoxyglucose positron emission tomography scan with with patients' clinical outcomes. (time frame: from the date of stem cell transplant to date of clinical disease progression or to date of last follow-up). It is what the study was designed to measure, not a finding.
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 26 Feb 2013; AzTrials last refreshed its copy on 6 Nov 2026.