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

This study has been terminated.

(Terminated by institutional review board)

Sponsor:

Collaborator:

Midwest Medical Isotopes

Information provided by:

University of Oklahoma

ClinicalTrials.gov Identifier:

NCT00775957

First received: October 17, 2008

Last updated: September 27, 2010

Last verified: September 2010

History of Changes

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


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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma Nuclear Scans

Genetic and Rare Diseases Information Center resources: Lymphosarcoma

U.S. FDA Resources

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 ]


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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:	Jennifer Holter, MD, University of Oklahoma Health Sciences Center- Dept. of Medicine
ClinicalTrials.gov Identifier:	NCT00775957 History of Changes
Other Study ID Numbers:	FLT-NHL
Study First Received:	October 17, 2008
Last Updated:	September 27, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms	Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases

ClinicalTrials.gov processed this record on September 28, 2016

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