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FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01410630
Recruitment Status : Completed
First Posted : August 5, 2011
Last Update Posted : May 11, 2021
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:
A research study of a new method of visualizing internal organs called 18F-FLT PET/CT that yields better tracking of cancer treatment progress. PET/CT stands for positron emission tomography with low dose computed tomography and has been used for many years. 18F-FLT PET/CT uses a new tracer, fluorothymidine, which is taken up by cells that are actively proliferating or dividing such as cancer cells. We hope to learn whether this tracer is superior to the conventional tracer for monitoring treatment of diffuse large B-cell lymphoma (DLBCL).

Condition or disease Intervention/treatment
Lymphoma Lymphoma, Non-Hodgkin Large B Cell Diffuse Lymphoma Diagnostic Test: FLT-PET/CT Diagnostic Test: FDG-PET/CT Drug: FLT

Detailed Description:

-Primary Objective

Investigate whether the PPV of FLT-PET/CT is significantly higher than that of FDG-PET/CT by following up patients for at least 24 months post-therapy or until evidence of persistent disease/disease progression.

-Secondary Objectives

Investigate whether the event free survival (EFS) of patients with FDG-PET/CT-positive and FLT-PET/CT negative scans is not significantly lower than that of patients with concordantly negative FDG-PET/CT and FLT-PET/CT scans and that the NPV or FLT-PET/CT is similar to that of FDG-PET/CT

Correlate interim FLT-PET/CT and FDG-PET/CT with the International Prognostic Index (IPI), a well-established predictor of outcome in DLBCL, to determine their independent prognostic value from the IPI

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Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
Actual Study Start Date : September 7, 2017
Actual Primary Completion Date : October 4, 2019
Actual Study Completion Date : October 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Group/Cohort Intervention/treatment
FLT-PET/CT and FDG-PET/CT scan
Patients will have FLT-PET/CT and FDG-PET/CT scans performed 18-24 days after the second cycle of R-CHOP.
Diagnostic Test: FLT-PET/CT
Standard of Care
Other Name: FLT Positive Emission Tomography

Diagnostic Test: FDG-PET/CT
Standard of Care
Other Name: FDB Positive Emission Tomography

Drug: FLT
5 mCi IV
Other Name: fluoro-L-thymidine




Primary Outcome Measures :
  1. Positive Predictive Value (PPV) of 3'-deoxy-3'-[F-18]-fluorothymidine (FLT) Positron emission tomography (PET/CT) versus Fluorodeoxyglucose (FDG)PET/CT [ Time Frame: 24 Months ]

Secondary Outcome Measures :
  1. Overall survival after initiation of therapy [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
18 years of age or older
Criteria

Inclusion Criteria:

  • All patients must have a histologic or cytological diagnosis of de novo DLBCL and be scheduled to receive first line chemotherapy with R-CHOP given every 21 days (R-CHOP-21) within 6 weeks of their enrollment and for 6 cycles.
  • Patients must be >=18 years of age, but there will be no discrimination based on gender, race, creed, or ethnic background.
  • Patients must have an ECOG performance status of 0-2.
  • Patients must sign an informed consent, and be mentally responsible.

Exclusion Criteria:

  • Subjects with significant concurrent medical complications that in the judgment of the Principal Investigator(s) could affect the patient's ability to complete the planned trial, including the multiple imaging studies.
  • Patients with history of prior lymphoma (e.g., follicular lymphoma) and/or second cancers other than basal cell carcinoma.
  • Patients planned to be treated with R-CHOP-14 (i.e., R-CHOP given every 14 days) will be excluded (this should be extremely rare, if at all, since R-CHOP-21 is the standard treatment.
  • Patients who are scheduled to receive Rituxan or any other therapy (e.g., XRT, radioimmunotherapy) as adjuvant therapy after completion of R-CHOP-21.
  • Pregnant women will be excluded.
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) after study entry and for the duration of study participation. The effects of FLT on the developing human fetus are unknown. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A screening urine human chorionic gonadtropin (hCG) (pregnancy test) will be administered in Nuclear Medicine to women of childbearing potential before each FLT scan and pregnant women will be stopped from participating further in this study.

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): NCT01410630


Locations
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United States, California
University of California at Los Angeles
Los Angeles, California, United States, 90024
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, Texas
MD Anderson Cancer Center - University of Texas
Houston, Texas, United States, 77030
Germany
Aachen University
Aachen, Germany
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Andrew Quon, MD University of California at Los Angeles
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01410630    
Other Study ID Numbers: 17-001275
SU-07072011-8046 ( Other Identifier: Stanford University )
19997 ( Other Identifier: Stanford IRB )
17-001275 ( Other Identifier: UCLA IRB )
JCCCID811 ( Other Identifier: Jonsson CCC )
First Posted: August 5, 2011    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Telbivudine
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action