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Fludeoxyglucose F 18 PET Scans in Predicting Outcomes in Patients Who Have Undergone High-Dose Chemotherapy and Autologous Stem Cell Transplant for Non-Hodgkin Lymphoma
This study has been completed.
First Received: July 9, 2008   Last Updated: March 14, 2009   History of Changes
Sponsors and Collaborators: Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00712556
  Purpose

RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18 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 fludeoxyglucose F 18 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: fludeoxyglucose F 18
Phase I

MedlinePlus related topics: Cancer Lymphoma Nuclear Scans
Drug Information available for: Fluorodeoxyglucose F18
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Open Label
Official Title: Positron Emission Tomography Study in Patients With Non-Hodgkin Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Correlation of sensitivity, specificity, positive predictive value, and negative predictive value of fludeoxyglucose F 18 positron emission tomography scan with clinical outcome [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 63
Study Start Date: May 2008
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To determine if a fludeoxyglucose F 18 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 response, disease progression/relapse, or death related to the primary disease).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 fludeoxyglucose F 18 positron emission tomography within 70 days prior to and/or at approximately 30 days and 100 days after high-dose chemotherapy and autologous stem cell transplantation

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

Additional Information:
No publications provided

Study ID Numbers: CDR0000596047, VU-VICC-BMT-0828, VU-VICC-080426
Study First Received: July 9, 2008
Last Updated: March 14, 2009
ClinicalTrials.gov Identifier: NCT00712556     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Sezary Syndrome
Lymphoma, B-Cell, Marginal Zone
Mantle Cell Lymphoma
Mycosis Fungoides
Lymphoblastic Lymphoma
Follicular Lymphoma
Lymphoma, Large-cell, Immunoblastic
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Mycoses
Cutaneous T-cell Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, T-Cell
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Large-cell
Leukemia, B-cell, Chronic
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Small Non-cleaved Cell Lymphoma
Recurrence
Burkitt's Lymphoma
Lymphatic Diseases
Chronic Lymphocytic Leukemia
B-cell Lymphomas
Burkitt Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders

Additional relevant MeSH terms:
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Lymphoma, Large-Cell, Immunoblastic
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009