NCT01410630

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 5, 2011

Completed
6.1 years until next milestone

Study Start

First participant enrolled

September 7, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2019

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

2.1 years

First QC Date

July 22, 2011

Last Update Submit

May 6, 2021

Conditions

LymphomaLymphoma, Non-HodgkinLarge B Cell Diffuse Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Positive Predictive Value (PPV) of 3'-deoxy-3'-[F-18]-fluorothymidine (FLT) Positron emission tomography (PET/CT) versus Fluorodeoxyglucose (FDG)PET/CT

    24 Months

Secondary Outcomes (1)

  • Overall survival after initiation of therapy

    24 months

Study Arms (1)

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/CTDiagnostic Test: FDG-PET/CTDrug: FLT

Interventions

FLT-PET/CTDIAGNOSTIC_TEST

Standard of Care

Also known as: FLT Positive Emission Tomography
FLT-PET/CT and FDG-PET/CT scan
FDG-PET/CTDIAGNOSTIC_TEST

Standard of Care

Also known as: FDB Positive Emission Tomography
FLT-PET/CT and FDG-PET/CT scan
FLTDRUG

5 mCi IV

Also known as: fluoro-L-thymidine
FLT-PET/CT and FDG-PET/CT scan

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

18 years of age or older

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of California at Los Angeles

Los Angeles, California, 90024, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

MD Anderson Cancer Center - University of Texas

Houston, Texas, 77030, United States

Location

Aachen University

Aachen, Germany

Location

MeSH Terms

Conditions

LymphomaLymphoma, Non-HodgkinLymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-Cell

Study Officials

  • Andrew Quon, MD

    University of California at Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2011

First Posted

August 5, 2011

Study Start

September 7, 2017

Primary Completion

October 4, 2019

Study Completion

October 4, 2019

Last Updated

May 11, 2021

Record last verified: 2021-05

Locations

DE(1)US(3)