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

Hodgkin's Lymphoma Clinical Trial

— 2P-HD-10  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01399931
• Other study ID #: 2P-HD-10 STUDY
• Status: Recruiting
• Phase: N/A
• First received: July 21, 2011
• Last updated: October 16, 2015
• Start date: January 2012
• Est. completion date: January 2017

Study information

• Verified date: October 2015
• Source: Ospedale Santa Croce-Carle Cuneo
• Contact: ANDREA GALLAMINI, MD
• Phone: +390171642414
• Email: gallamini.a[@]ospedale.cuneo.it
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma

Locations

Country	Name	City	State
Italy	Ospedale Santi Antonio E Biagio E Cesare Arrigo	Alessandria	AL
Italy	Azienda Sanitaria Ospedaliera S. Croce E Carle	Cuneo
Italy	Azienda Ospedaliera Universitaria S. Martino	Genova	GE
Italy	Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte	Messina	ME
Italy	Azienda Ospedaliera S. Gerardo	Monza	MB
Italy	Azienda Ospedaliera S. Giovanni Battista	Torino	TO

Sponsors (3)

Lead Sponsor	Collaborator
Ospedale Santa Croce-Carle Cuneo	Consorzio Mario Negri Sud, Fondazione Italiana Linfomi ONLUS

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Gallamini A, Hutchings M, Rigacci L, Specht L, Merli F, Hansen M, Patti C, Loft A, Di Raimondo F, D'Amore F, Biggi A, Vitolo U, Stelitano C, Sancetta R, Trentin L, Luminari S, Iannitto E, Viviani S, Pierri I, Levis A. 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. Epub 2007 Jul 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No