Dual Point PET Scan in Early Stage Hodgkin Lymphoma Patients With Bulky Lesions

• Conditions: Hodgkin's Lymphoma

• Registration Number: NCT01399931
• Lead Sponsor: Ospedale Santa Croce-Carle Cuneo

Brief Summary

To assess specificity and overall accuracy of interim dual-point acquisition PET in predicting treatment outcome.

The study is aimed at assessing the specificity of interim dual-point PET performed after 2 ABVD cycles to predict treatment outcome in early-stage Hodgkin's Lymphoma patients presenting bulky lesions at baseline.

Detailed Description

The proposed study is an non-interventional survey of a cohort of patients in whom interim PET scan is performed only for prognostic aims.

PET with 18F-FDG is a standard staging procedure for most lymphoma subtypes. Performed early during the therapy for Hodgkin's lymphoma (HL) its results have a high prognostic value and is the main predictor of treatment outcome. From 2006 onward, interim-PET after 2 ABVD courses has been increasingly performed in the daily clinical practice as a routine test for disease prognosis, and now it can be considered as a standard prognostic tool.

The novelty of the study relies on a new method for interim-PET scan execution: a dynamic study, with 2 different time points of image acquisition. This could potentially enable us to discriminate between unspecific, inflammatory DG uptake, from a "true" uptake form persisting viable neoplastic cells. Therefore, the main aim of the study is reducing false positive results in the interim-PET scan interpretation. Since dynamic changes of FDG uptake in Hodgkin's lymphoma are still unknown we propose, in the present study, to assess the by the same acquisition technique the pattern of FDG uptake at baseline in untreated patients affected by this neoplasm.

The Institutions equipped with a Magnetic Resonance scanners and a diffusion weighted imaging analysis technique (DW-MRI), could participate to the DW-MRI sub-study.

Study Timeline

• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-21
• Study First Posted: 2011-07-22
• Study Start: 2012-01
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Last Update Submitted: 2015-10-16
• Last Update Posted: 2015-10-19
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Hodgkin lymphoma diagnosis according all the WHO classification subtype but lymphocyte predominance.
• Age 18 - 60 years old
• stage IA- IIA (by FDG-PET scan)
• Presence of bulky tumour (either in Mediastinum or other site)
• Treatment with ABVD x 4 (early stage)
• Consolidation Radiotherapy on bulky lesion
• Signed the Informed consent form

Exclusion Criteria

• Diabetes mellitus uncompensated
• Lymphocyte predominance histology
• Pregnancy or lactation
• Implanted biomedical devices (for DW-MRI sub study)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event free survival (EFS)	1 year	To assess feasibility of using interim dual-point acquisition PET in real world of clinical practice as well as describing the outcome of early stage HL patients.

Secondary Outcome Measures

Name	Time	Method
Evaluation of inflammation markers prognostic role	3 years	To assess prognostic value of inflammation markers (ESR, CRP, Ferritin, Transferrin, Fibrinogen, Alpha 2-globulins) as biomarkers of treatment outcome in early stage HL patients

Trial Locations

Locations (6)

Azienda Ospedaliera S. Gerardo; 🇮🇹 Monza, MB, Italy

Azienda Ospedaliera Universitaria S. Martino; 🇮🇹 Genova, GE, Italy

Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte; 🇮🇹 Messina, ME, Italy

Ospedale Santi Antonio E Biagio E Cesare Arrigo; 🇮🇹 Alessandria, AL, Italy

Azienda Ospedaliera S. Giovanni Battista; 🇮🇹 Torino, TO, Italy

Azienda Sanitaria Ospedaliera S. Croce E Carle; 🇮🇹 Cuneo, Italy