Clinical trial NCT01399931: Dual Point PET Scan in Early Stage Hodgkin Lymphoma Patients With Bulky Lesions
Official title: Dual Point Acquisition in the Interim Pet Scan Performed During ABVD Treatment, in Early-Stage Hodgkin's Lymphoma Patients With Bulky Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hodgkin's Lymphoma
Keywords: Early stage
Lead sponsor: Ospedale Santa Croce-Carle Cuneo
Sponsor class: OTHER
Collaborators: name: Consorzio Mario Negri Sud
name: Fondazione Italiana Linfomi - ETS
First posted: 2011-07-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Event free survival (EFS)
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of inflammation markers prognostic role
timeFrame: 3 years
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Ospedale Santi Antonio E Biagio E Cesare Arrigo
state: AL
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria S. Martino
state: GE
city: Monza
country: Italy
facility: Azienda Ospedaliera S. Gerardo
state: MB
city: Messina
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte
state: ME
city: Torino
country: Italy
facility: Azienda Ospedaliera S. Giovanni Battista
state: TO
city: Cuneo
country: Italy
facility: Azienda Sanitaria Ospedaliera S. Croce E Carle
Study officials:
affiliation: Azienda Sanitaria Ospedaliera Santa Croce e Carle Cuneo
name: Andrea Gallamini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gallamini A.:Positron emission tomography scanning: a new paradigm for the management of Hodgkin's lymphoma. Haematologica 2010;95, 1-3 Gallamini A, Rigacci L, Merli F, Nassi L, Bosi A, Capodanno I, et al. The predictive value of positron emission tomography scanning performed after two courses of standard therapy on treatment outcome in advanced stage Hodgkin's disease. Haematologica 2006 Apr;91(4):475-81. Meignan M, Itti E, Gallamini A, Haioun C. Interim 18F-fluorodeoxyglucose positron emission tomography in diffuse large B-cell lymphoma: qualitative or quantitative interpretation - where do we stand? Leukemia & Lymphoma 2009; 50(11) 1753-56. Gallamini A, Hutchings M, Rigacci L, Specht L, Merli F, Hansen M, et al. Early interim 2-[18F]fluoro-2-deoxy-D-glucose positron emission tomography is prognostically superior to international prognostic score in advanced-stage Hodgkin's lymphoma: a report from a joint Italian-Danish study. J Clin Oncol 2007 Aug 20;25(24):3746-52.