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

May 6, 2021 updated by: Jonsson Comprehensive Cancer Center
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

66

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

  • Germany
      • Aachen, Germany
        • Aachen University
  • United States
    • California
      • Los Angeles, California, United States, 90024
        • University of California at Los Angeles
    • Nebraska
      • Omaha, Nebraska, United States, 68198-7680
        • University of Nebraska Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center - University of Texas

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

18 years of age or older

Description

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.

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
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 Names:
  • FLT Positive Emission Tomography
Diagnostic test: FDG-PET/CT
Standard of Care
Other Names:
  • FDB Positive Emission Tomography
Drug: FLT
5 mCi IV
Other Names:
  • fluoro-L-thymidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival after initiation of therapy
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Andrew Quon, MD, University of California at Los Angeles

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 (ACTUAL)

September 7, 2017

Primary Completion (ACTUAL)

October 4, 2019

Study Completion (ACTUAL)

October 4, 2019

Study Registration Dates

First Submitted

July 22, 2011

First Submitted That Met QC Criteria

August 3, 2011

First Posted (ESTIMATE)

August 5, 2011

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-001275 (OTHER: UCLA IRB)
  • SU-07072011-8046 (OTHER: Stanford University)
  • 19997 (OTHER: Stanford IRB)
  • JCCCID811 (OTHER: Jonsson CCC)

Drug and device information, study documents

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

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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