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| Name | Class |
|---|---|
| Consorzio Mario Negri Sud | OTHER |
| Fondazione Italiana Linfomi - ETS | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early-stage Hodgkin Lymphoma Patients | Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions treated with ABVD and consolidation radiotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Event free survival (EFS) | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of inflammation markers prognostic role | 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 | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ANDREA GALLAMINI, MD | Contact | +390171642414 | gallamini.a@ospedale.cuneo.it | |
| MARIA ROSARIA MENNITTO, PHARM D | Contact | +390171642415 | mennitto.m@ospedale.cuneo.it |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Gallamini, MD | Azienda Sanitaria Ospedaliera Santa Croce e Carle Cuneo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Santi Antonio E Biagio E Cesare Arrigo | Recruiting | Alessandria | AL | 15100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| Azienda Sanitaria Ospedaliera S. Croce E Carle | Recruiting | Cuneo | Cuneo | 12100 | Italy |
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| Azienda Ospedaliera Universitaria S. Martino | Recruiting | Genova | GE | 16132 | Italy |
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| Azienda Ospedaliera S. Gerardo | Recruiting | Monza | MB | 20900 | Italy |
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| Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte | Recruiting | Messina | ME | 98158 | Italy |
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| Azienda Ospedaliera S. Giovanni Battista | Recruiting | Torino | TO | 10126 | Italy |
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |