NCT00712556

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2008

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

February 26, 2013

Status Verified

February 1, 2013

Enrollment Period

10 months

First QC Date

July 9, 2008

Last Update Submit

February 25, 2013

Conditions

Lymphoma

Keywords

stage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III small lymphocytic lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV small lymphocytic lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood small noncleaved cell lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomarecurrent mycosis fungoides/Sezary syndromenodal marginal zone B-cell lymphomasplenic marginal zone lymphomaNC stage II adult immunoblastic large cell lymphomaNC stage II adult lymphoblastic lymphomaNC stage II grade 1 follicular lymphomaNC stage II grade 2 follicular lymphomaNC stage II grade 3 follicular lymphomaNC stage II mantle cell lymphomaNC stage II marginal zone lymphomaNC stage II small lymphocytic lymphoma

Outcome Measures

Primary Outcomes (1)

  • Correlation of sensitivity, specificity, positive predictive value, and negative predictive value of fluorine 18-fludeoxyglucose positron emission tomography scan with with patients' clinical outcomes.

    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

    from date of stem cell transplant to date of clinical disease progression or date of last follow-up

Study Arms (1)

Flourine 18-fluorodeoxyglucose PET

PET using fluorine 18-fluorodeoxyglucose to image cancer tumors

Radiation: fluorine 18-fludeoxyglucose positron emission tomography

Interventions

fluorine 18-fludeoxyglucose positron emission tomographyRADIATION

fluorine 18-fludeoxyglucose is a radioactive isotope used in PET to detect cancer tumors

Also known as: fluorine 18-fludeoxyglucose PET
Flourine 18-fluorodeoxyglucose PET

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with non-Hodgkin lymphoma

You may qualify if:

  • 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

You may not qualify if:

  • PATIENT CHARACTERISTICS:
  • Not specified
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

LymphomaBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellDendritic Cell Sarcoma, InterdigitatingLymphoma, T-Cell, CutaneousMycosis FungoidesSezary Syndrome

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHistiocytic Disorders, MalignantHistiocytosisLymphoma, T-Cell

Study Officials

  • Adetola A. Kassim, MD

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine; Clinical Director, Sickle Cell Anemia Program; Hematologist/Oncologist

Study Record Dates

First Submitted

July 9, 2008

First Posted

July 10, 2008

Study Start

May 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 26, 2013

Record last verified: 2013-02

Locations

US(3)