- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00775957
Assessment of Hematopoietic Recovery Following Chemotherapy for Non-Hodgkin's Lymphoma
September 27, 2010 updated by: University of Oklahoma
Assessment of Hematopoietic Recovery Following Chemotherapy for Non-Hodgknin's Lymphoma
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
35
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Subjects diagnosed with lymphoma and are about to start treatment with chemotherapy
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
FLT-PET Scan
|
imaging scan
|
|
2
FDG-PET Scan
|
imaging scan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Staging and ReStaging scans
Time Frame: after hematopoetic recovery
|
after hematopoetic recovery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Study Registration Dates
First Submitted
October 17, 2008
First Submitted That Met QC Criteria
October 17, 2008
First Posted (Estimate)
October 20, 2008
Study Record Updates
Last Update Posted (Estimate)
September 28, 2010
Last Update Submitted That Met QC Criteria
September 27, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FLT-NHL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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