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

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ClinicalTrials.gov Identifier: NCT00775957
Recruitment Status : Terminated (Terminated by institutional review board)
First Posted : October 20, 2008
Last Update Posted : September 28, 2010
Sponsor:
Collaborator:
Midwest Medical Isotopes
Information provided by:
University of Oklahoma

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
Non-Hodgkin's Lymphoma Procedure: FLT-PET scan Procedure: FDG-PET 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Hematopoietic Recovery Following Chemotherapy for Non-Hodgknin's Lymphoma
Study Start Date : October 2008

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
1
FLT-PET Scan
 Procedure: FLT-PET scan
imaging scan
2
FDG-PET Scan
 Procedure: FDG-PET scan
imaging scan


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Staging and ReStaging scans [ Time Frame: after hematopoetic recovery ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: October 20, 2008    Key Record Dates
Last Update Posted: September 28, 2010
Last Verified: September 2010

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