Dual Point PET Scan in Early Stage Hodgkin Lymphoma Patients With Bulky Lesions (2P-HD-10)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Dual Point Acquisition in the Interim Pet Scan Performed During ABVD Treatment, in Early-Stage Hodgkin's Lymphoma Patients With Bulky Lesions|
- Event free survival (EFS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
- Evaluation of inflammation markers prognostic role [ Time Frame: 3 years ] [ Designated as safety issue: No ]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
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Early-stage Hodgkin Lymphoma Patients
Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions treated with ABVD and consolidation radiotherapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399931
|Contact: ANDREA GALLAMINI, MDfirstname.lastname@example.org|
|Contact: MARIA ROSARIA MENNITTO, PHARM Demail@example.com|
|Ospedale Santi Antonio E Biagio E Cesare Arrigo||Recruiting|
|Alessandria, AL, Italy, 15100|
|Contact: ALESSANDRO LEVIS, MD +390131206156 firstname.lastname@example.org|
|Principal Investigator: ALESSANDRO LEVIS, MD|
|Azienda Ospedaliera Universitaria S. Martino||Recruiting|
|Genova, GE, Italy, 16132|
|Contact: ANGELO M CARELLA, MD +39010513731 email@example.com|
|Principal Investigator: ANGELO M CARELLA, MD|
|Azienda Ospedaliera S. Gerardo||Recruiting|
|Monza, MB, Italy, 20900|
|Contact: SILVIA BOLIS, MD +390392339383 firstname.lastname@example.org|
|Principal Investigator: SILVIA BOLIS, MD|
|Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte||Recruiting|
|Messina, ME, Italy, 98158|
|Contact: DONATO MANNINA, MD +390903992253 email@example.com|
|Principal Investigator: DONATO MANNINA, MD|
|Azienda Ospedaliera S. Giovanni Battista||Recruiting|
|Torino, TO, Italy, 10126|
|Contact: PAOLO GAVAROTTI, MD +393479632795 firstname.lastname@example.org|
|Principal Investigator: PAOLO GAVAROTTI, MD|
|Azienda Sanitaria Ospedaliera S. Croce E Carle||Recruiting|
|Cuneo, Italy, 12100|
|Contact: ANDREA GALLAMINI, MD +390171642414 email@example.com|
|Contact: ALBERTO BIGGI, MD 00390171641558 firstname.lastname@example.org|
|Principal Investigator: Andrea Gallamini, MD|
|Principal Investigator:||Andrea Gallamini, MD||Azienda Sanitaria Ospedaliera Santa Croce e Carle Cuneo|