The Use of FDG-PET in Patient With Hodgkin Lymphoma: a Population Based Study From Northern Italy

November 24, 2010 updated by: Gruppo Italiano Studio Linfomi

The Use of FDG Positron Emission Tomography (PET)in Patient With Hodgkin Lymphoma (HL) in the "Real World": a Population Based Study From Northern Italy

Positron Emission Tomography (PET) represents a step forward in the definition of response to therapy in patients with Hodgkin Lymphoma (HL). In particular the use of PET for the early assessment of response has been described as the most important tool for predicting the risk of disease progression. As no data are available to support the use of early assessment of response for adapting and modifying subsequent treatment, the use of PET should be limited only to patients enrolled in clinical trials. Irrespective of recommendations PET scanning is included in the current management of patients with HL at baseline, mid treatment, end of treatment, and follow-up. So far no study has been performed to verify how PET is currently used in the clinical setting and to assess if and how results of PET scanning are used for supporting treatment and clinical decisions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

136

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

  • Italy
      • Modena, Italy, 41124
        • Registro Tumori di Modena

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All cases of classical Hodgkin lymphoma diagnosed between 2006 and 2008 in the province of Modena, Reggio Emilia, Parma and Ferrara will be considered eligible for this study.

Description

Inclusion Criteria:

  1. Histologically confirmed classical Hodgkin lymphoma according to the current World Health Organisation Classification (nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted).
  2. Clinical stage I-IV.
  3. No previous chemotherapy, radiotherapy or other investigational drug for HL.

Exclusion Criteria:

1. None.

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
classical Hodgkin lymphoma
All cases of classical Hodgkin lymphoma diagnosed between 2006 and 2008 in the province of Modena, Reggio Emilia, Parma and Ferrara will be considered eligible for this study.
Procedure: FDG-PET
PET interpretation is based on a site-to-site comparison of FDG uptake both before and after chemotherapy (qualitative approach), according to the criteria defined by Cheson (2008)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: within 1 month after end of treatment
within 1 month after end of treatment
Overall survival
Time Frame: within 1 month after end of treatment
within 1 month after end of treatment
Disease-free survival
Time Frame: within 1 month after end of treatment
within 1 month after end of treatment

Collaborators and Investigators

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

Sponsor

Gruppo Italiano Studio Linfomi

Collaborators

Registro Tumori di Modena
Registro Tumori di Reggio Emilia
Registro Tumori di Parma
registro Tumori di Ferrara

Investigators

  • Study Chair: Massimo Federico, MD, Università di Modena e Reggio Emilia

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

May 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

November 23, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (Estimate)

November 25, 2010

Study Record Updates

Last Update Posted (Estimate)

November 25, 2010

Last Update Submitted That Met QC Criteria

November 24, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PET-LH

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.

Clinical Trials on Histologically Confirmed Classical Hodgkin Lymphoma According to the Current World Health Organisation Classification

  • Affiliated Hospital to Academy of Military Medical...
    Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Peking...
    Recruiting
    Phase II Trial of Tirelizumab Combined With R2-ICE Regimen in the Treatment of rrDLBCL/HGBL
    Age Range ≥16 Years, Gender Unlimited | Histopathology Confirmed Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma | Received Prior First-line Chemotherapy for DLBCL or HGBL, Failed to Reach CR for Four Cycles, or Relapsed | At Least One Positive Lesion According to the 2014... and other conditions
    China

Clinical Trials on FDG-PET

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe