PET Study in Patients With Non-Hodgkin Lymphoma
This study has been completed.
Sponsor:
Vanderbilt-Ingram Cancer Center
Information provided by (Responsible Party):
Adetola A. Kassim, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00712556
First received: July 9, 2008
Last updated: February 25, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Radiation: fluorine 18-fludeoxyglucose positron emission tomography |
Phase 1 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Positron Emission Tomography Study in Patients With Non-Hodgkin Lymphoma |
Resource links provided by NLM:
Further study details as provided by Vanderbilt-Ingram Cancer Center:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: from date of stem cell transplant to date of clinical disease progression or date of last follow-up ] [ Designated as safety issue: No ]
| Enrollment: | 55 |
| Study Start Date: | May 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Flourine 18-fluorodeoxyglucose PET
PET using fluorine 18-fluorodeoxyglucose to image cancer tumors
|
Radiation: fluorine 18-fludeoxyglucose positron emission tomography
fluorine 18-fludeoxyglucose is a radioactive isotope used in PET to detect cancer tumors
Other Name: fluorine 18-fludeoxyglucose PET
|
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).
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with non-Hodgkin lymphoma
Criteria
Inclusion Criteria:
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
Exclusion Criteria:
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712556
Locations
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | |
| Nashville, Tennessee, United States, 37064 | |
| Vanderbilt-Ingram Cancer Center at Franklin | |
| Nashville, Tennessee, United States, 37064 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
| Principal Investigator: | Adetola A. Kassim, MD | Vanderbilt-Ingram Cancer Center |
More Information
No publications provided
| Responsible Party: | Adetola A. Kassim, Associate Professor of Medicine; Clinical Director, Sickle Cell Anemia Program; Hematologist/Oncologist, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00712556 History of Changes |
| Other Study ID Numbers: | VICC BMT 0828, VU-VICC-BMT-0828, VU-VICC-080426 |
| Study First Received: | July 9, 2008 |
| Last Updated: | February 25, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Vanderbilt-Ingram Cancer Center:
|
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 stage IV grade 3 follicular lymphoma stage IV mantle cell lymphoma stage IV marginal zone lymphoma stage IV small lymphocytic lymphoma recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Fluorides Cariostatic Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013