PET Study in Patients With Non-Hodgkin Lymphoma

Lymphoma Clinical Trial

Official title:

Positron Emission Tomography Study in Patients With Non-Hodgkin Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712556
• Other study ID #: VICC BMT 0828
• Secondary ID: VU-VICC-BMT-0828
• Status: Completed
• Phase: Phase 1
• First received: July 9, 2008
• Last updated: February 25, 2013
• Start date: May 2008
• Est. completion date: March 2009

Study information

• Verified date: February 2013
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical 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.

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Radiation:
• fluorine 18-fludeoxyglucose positron emission tomography
fluorine 18-fludeoxyglucose is a radioactive isotope used in PET to detect cancer tumors

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Progression-free survival		from date of stem cell transplant to date of clinical disease progression or date of last follow-up	No