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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Andrew Quon, Stanford University
ClinicalTrials.gov Identifier:
NCT01410630
First received: July 22, 2011
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

Patients will undergo conventional staging methods (CSM), including PDG-PET/CT, for their disease within 4 weeks prior to planned initiation of R-CHOP given for 6 cycles every 3 weeks. These patients will then have FLT-PET/CT and FDG-PET/CT scans performed 18-24 days after the second cycle of R-CHOP. After completion of six cycles of chemotherapy, CSM will be repeated, including FDG-PET/CT but only if the post cycle 2 FDG-PET/CT was positive to assess response and determine the appropriate patient management.


Condition Intervention
Lymphoma
Lymphoma, Non-Hodgkin
Large B Cell Diffuse Lymphoma
Procedure: FLT-PET/CT
Procedure: FDG-PET/CT
Drug: FLT

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival after initiation of therapy [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 137
Study Start Date: September 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: FLT-PET/CT
Standard of Care
Other Name: FLT Positive Emission Tomography
Procedure: FDG-PET/CT
Standard of Care
Other Name: FDB Positive Emission Tomography
Drug: FLT
5 mCi IV
Other Name: fluoro-L-thymidine

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410630

Contacts
Contact: Euodia Jonathan 650-723-7419 euodia@stanford.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94304
Contact: Euodia Jonathan    650-723-7419    euodia@stanford.edu   
Principal Investigator: Andrew Quon         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-7680
Contact: Susan Allen, RN, BSN    402-559-8155    msallen@unmc.edu   
Principal Investigator: Jordan H Hankins, MD         
United States, Texas
MD Anderson Cancer Center - University of Texas Recruiting
Houston, Texas, United States
Contact: Jordon Antonia       avjordan@mdanderson.org   
Principal Investigator: Alma Rodriguez, M.D., F.A.C.P.         
Germany
Aachen University Recruiting
Aachen, Germany
Contact: Malik Juweid    01149241-8 0 35905    mjuweid@ukaachen.de   
Principal Investigator: Malik Juweid, MD         
Sponsors and Collaborators
Andrew Quon
Investigators
Principal Investigator: Dr Andrew Quon Stanford University
  More Information

No publications provided

Responsible Party: Andrew Quon, Assistant Professor Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT01410630     History of Changes
Other Study ID Numbers: LYMIMG0001, SU-07072011-8046, 19997
Study First Received: July 22, 2011
Last Updated: February 14, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014