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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dual Point Acquisition in the Interim Pet Scan Performed During ABVD Treatment, in Early-Stage Hodgkin's Lymphoma Patients With Bulky Lesions

Conditions
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Hodgkin's Lymphoma

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early-stage Hodgkin Lymphoma Patients<br>Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions treated with ABVD and consolidation radiotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early stage