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Completed

NCT Number: NCT01248000

The Use of FDG-PET in Patient With Hodgkin Lymphoma: 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.

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Key information

Conditions

Histologically Confirmed Classical Hodgkin Lymphoma According to the Current World Health Organisation Classification Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Registro Tumori di Modena

Modena, 41124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None.

Treatment and study plan

FDG-PET

Procedure

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)

Primary outcomes

  1. Progression-free survival

    Time frame: within 1 month after end of treatment

  2. Overall survival

    Time frame: within 1 month after end of treatment

  3. Disease-free survival

    Time frame: within 1 month after end of treatment

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Studio Linfomi

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2009
Study completion
2010
First posted
Nov 25, 2010
Registry last updated
Nov 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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