Text Size

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:

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
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

No publications provided

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 May 22, 2013