Clinical Usefulness and Prognostic Significance of Interim 18F-FDG PET/CT for the Treatment of Peripheral T Cell Lymphomas

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Chonnam National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Kyungpook National University
Information provided by:
Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT01470066
First received: November 3, 2011
Last updated: November 10, 2011
Last verified: September 2005
  Purpose

Although interim 18F-fluoro-2-deoxy-D-glucose-positron emission tomography (FDG-PET)/computerized tomography (CT) scan has emerged as a powerful prognostic tool in predicting treatment outcome in Hodgkin's lymphoma (HL) and diffuse large B cell lymphoma (DLBCL), the positive predictive value (PPV) of interim PET/CT scanning has not been determined in patients with peripheral T cell lymphoma (PTCL). The sequential interim PET/CT will be prospectively investigated to determine whether it provided additional prognostic information and could be a positive predictable value for the treatment of PTCL.


Condition
Peripheral T Cell Lymphoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Chonnam National University Hospital:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: From the treatment start time to the first recording of disease progression or death from any cause, which assessed up to 24 months. ] [ Designated as safety issue: No ]
    Patients whose disease did not progress would be censored using the date at which they were last known to show no progress.


Estimated Enrollment: 80
Study Start Date: August 2004
Estimated Study Completion Date: May 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study is the observational study for the response assessments on interim PET/CT during the treatment of peripheral T cell lymphomas. Thus, first analysis of clinical data will be performed at the time of 80 patients enrolled or after a median follow-up of more than 12 months.

Criteria

Inclusion Criteria:

  1. Age above 18 years
  2. Histologically proven PTCLs except primary cutaneous/subcutaneous panniculitis
  3. ECOG performance status ≤ 2
  4. Patients who are available to be performed PET/CT at diagnosis
  5. No severe concomitant disease

Exclusion Criteria:

  1. Patients who did not undergo PET/CT scans at diagnosis
  2. Patients who have a primary CNS lymphoma
  3. Patients who have a HIV or HTLV-1
  4. Patients who could not receive primary chemotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470066

Contacts
Contact: Deok-Hwan Yang, M.D., Ph.D. 82-61-379-7636 drydh1685@gmail.com
Contact: Je-Jung Lee, M.D.,Ph.D.

Locations
Korea, Republic of
Chonnam National University Hwasun Hospital Recruiting
Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-809
Contact: So-Young Lee, Nurse     82-61-379-7628     kaosin@naver.com    
Principal Investigator: Deok-Hwan Yang, M.D.,Ph.D.            
Sponsors and Collaborators
Chonnam National University Hospital
Kyungpook National University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01470066     History of Changes
Other Study ID Numbers: PET2005-01
Study First Received: November 3, 2011
Last Updated: November 10, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Chonnam National University Hospital:
peripheral T cell lymphomas
interim PET/CT
prognosis
Positron-emission tomography/Computerized tomography

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

ClinicalTrials.gov processed this record on May 22, 2013