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

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

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248000
• Other study ID #: PET-LH
• Status: Completed
• Phase: N/A
• First received: November 23, 2010
• Last updated: November 24, 2010
• Start date: May 2009
• Est. completion date: May 2010

Study information

• Verified date: November 2010
• Source: Gruppo Italiano Studio Linfomi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Histologically Confirmed Classical Hodgkin Lymphoma According to the Current World Health Organisation Classification
• Hodgkin Disease
• Lymphoma

Intervention

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)

Locations

Country	Name	City	State
Italy	Registro Tumori di Modena	Modena

Sponsors (5)

Lead Sponsor	Collaborator
Gruppo Italiano Studio Linfomi	registro Tumori di Ferrara, Registro Tumori di Modena, Registro Tumori di Parma, Registro Tumori di Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		within 1 month after end of treatment	No
Primary	Overall survival		within 1 month after end of treatment	No
Primary	Disease-free survival		within 1 month after end of treatment	No