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

NCT ID: NCT01399931

Last Updated: 2015-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2017-01-31

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.

Conditions

Hodgkin's Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Early-stage Hodgkin Lymphoma Patients

Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions treated with ABVD and consolidation radiotherapy

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorzio Mario Negri Sud

OTHER

Sponsor Role: collaborator

Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role: collaborator

Ospedale Santa Croce-Carle Cuneo

OTHER

Sponsor Role: lead

Responsible Party

DR. ANDREA GALLAMINI

HEAD OF HAEMATOLOGY DEPT. A.S.O. S. CROCE AND CARLE

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Gallamini, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Sanitaria Ospedaliera Santa Croce e Carle Cuneo

Locations

Ospedale Santi Antonio E Biagio E Cesare Arrigo

Alessandria, AL, Italy

Site Status: RECRUITING

Azienda Sanitaria Ospedaliera S. Croce E Carle

Cuneo, Cuneo, Italy

Site Status: RECRUITING

Azienda Ospedaliera Universitaria S. Martino

Genova, GE, Italy

Site Status: RECRUITING

Azienda Ospedaliera S. Gerardo

Monza, MB, Italy

Site Status: RECRUITING

Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte

Messina, ME, Italy

Site Status: RECRUITING

Azienda Ospedaliera S. Giovanni Battista

Torino, TO, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

ANDREA GALLAMINI, MD

Role: CONTACT

gallamini.a@ospedale.cuneo.it

+390171642414

MARIA ROSARIA MENNITTO, PHARM D

Role: CONTACT

mennitto.m@ospedale.cuneo.it

+390171642415

Facility Contacts

ALESSANDRO LEVIS, MD

Role: primary

alevis@ospedale.al.it

+390131206156

ANDREA GALLAMINI, MD

Role: primary

gallamini.a@ospedale.cuneo.it

+390171642414

ALBERTO BIGGI, MD

Role: backup

biggi.a@ospedale.cuneo.it

00390171641558

ANGELO M CARELLA, MD

Role: primary

angelomichele.carella@hsmartino.it

+39010513731

SILVIA BOLIS, MD

Role: primary

s.bolis@hsgerardo.org

+390392339383

DONATO MANNINA, MD

Role: primary

d.mannina@alice.it

+390903992253

PAOLO GAVAROTTI, MD

Role: primary

pgavarotti@molinette.piemonte.it

+393479632795

References

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.

Reference Type: BACKGROUND

Other Identifiers

2P-HD-10 STUDY

Identifier Type: -

Identifier Source: org_study_id