Assessment of Hematopoietic Recovery Following Chemotherapy for Non-Hodgkin's Lymphoma

This study is enrolling participants by invitation only.

Sponsors and Collaborators:	University of Oklahoma Midwest Medical Isotopes
Information provided by:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00775957

Purpose

A study to determine the accuracy of FLT-PET in quantifying tumor cell proliferation at the initial staging of patients with Non-Hodgkin's Lymphoma in comparison wit the "gold standard" FDG-PET.

Condition	Intervention
Non-Hodgkin's Lymphoma	Procedure: FLT-PET scan Procedure: FDG-PET scan

MedlinePlus related topics: Lymphoma Nuclear Scans

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Assessment of Hematopoietic Recovery Following Chemotherapy for Non-Hodgknin's Lymphoma

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:

Staging and ReStaging scans [ Time Frame: after hematopoetic recovery ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	35
Study Start Date:	October 2008

Groups/Cohorts	Assigned Interventions
1 FLT-PET Scan	Procedure: FLT-PET scan imaging scan
2 FDG-PET Scan	Procedure: FDG-PET scan imaging scan

Detailed Description:

The first primary objective reflects a necessary and preliminary requirement: to reproduce published results and validate the use of FLT-PET. In this study, 35 patients will be selected to undergoing imaging with both FLT and FDG PET.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Subjects diagnosed with lymphoma and are about to start treatment with chemotherapy

Criteria

Inclusion Criteria:

18 years or older
Women must not be pregnant or breast feeding
Histologic diagnosis of non-Hodgkin's lymphoma (any stage)
Must undergo treatment with chemotherapy and/or radiotherapy

Exclusion Criteria:

May not have received previous therapy with radiopharmaceuticals
May not have received prior therapy with cytotoxic chemotherapy and/or monoclonal antibodies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775957

Locations

United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104

Sponsors and Collaborators

University of Oklahoma

Midwest Medical Isotopes

More Information

Responsible Party:	University of Oklahoma Health Sciences Center- Dept. of Medicine ( Jennifer Holter, MD )
Study ID Numbers:	FLT-NHL
Study First Received:	October 17, 2008
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00775957
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, small cleaved-cell, diffuse

Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009