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

Open (Enrolling)
Lymphoma, Lymphoma, Non-Hodgkin, Large B Cell Diffuse Lymphoma

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Trial Information

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

-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

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

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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

24 Months

Safety Issue:


Principal Investigator

Dr Andrew Quon

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

September 2011

Completion Date:

September 2015

Related Keywords:

  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Large B Cell Diffuse Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse



University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Stanford University School of MedicineStanford, California  94305-5317
MD Anderson Cancer Center - University of TexasHouston, Texas