Dual Point PET Scan in Early Stage Hodgkin Lymphoma Patients With Bulky Lesions (2P-HD-10)

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

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 Overview

• Status: Unknown
• Conditions: Hodgkin's Lymphoma

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: ANDREA GALLAMINI, MD; Phone Number: +390171642414; Email: gallamini.a@ospedale.cuneo.it
• Study Contact Backup: Name: MARIA ROSARIA MENNITTO, PHARM D; Phone Number: +390171642415; Email: mennitto.m@ospedale.cuneo.it

Study Locations

• Italy
  • Cuneo, Italy, 12100
    • Recruiting
    • Azienda Sanitaria Ospedaliera S. Croce e Carle
    • Contact: ANDREA GALLAMINI, MD; Phone Number: +390171642414; Email: gallamini.a@ospedale.cuneo.it
    • Contact: ALBERTO BIGGI, MD; Phone Number: 00390171641558; Email: biggi.a@ospedale.cuneo.it
  • AL
    • Alessandria, AL, Italy, 15100
      • Recruiting
      • Ospedale Santi Antonio E Biagio E Cesare Arrigo
      • Contact: ALESSANDRO LEVIS, MD; Phone Number: +390131206156; Email: alevis@ospedale.al.it
  • GE
    • Genova, GE, Italy, 16132
      • Recruiting
      • Azienda Ospedaliera Universitaria S. Martino
      • Principal Investigator: ANGELO M CARELLA, MD
      • Contact: ANGELO M CARELLA, MD; Phone Number: +39010513731; Email: angelomichele.carella@hsmartino.it
  • MB
    • Monza, MB, Italy, 20900
      • Recruiting
      • Azienda Ospedaliera S. Gerardo
      • Principal Investigator: Silvia Bolis, MD
      • Contact: SILVIA BOLIS, MD; Phone Number: +390392339383; Email: s.bolis@hsgerardo.org
  • ME
    • Messina, ME, Italy, 98158
      • Recruiting
      • Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte
      • Principal Investigator: Donato Mannina, MD
      • Contact: DONATO MANNINA, MD; Phone Number: +390903992253; Email: d.mannina@alice.it
  • TO
    • Torino, TO, Italy, 10126
      • Recruiting
      • Azienda Ospedaliera S. Giovanni Battista
      • Contact: PAOLO GAVAROTTI, MD; Phone Number: +393479632795; Email: pgavarotti@molinette.piemonte.it
      • Principal Investigator: PAOLO GAVAROTTI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Early-stage Hodgkin Lymphoma Patients; Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions treated with ABVD and consolidation radiotherapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ospedale Santa Croce-Carle Cuneo
• Collaborators: Fondazione Italiana Linfomi ONLUS; Consorzio Mario Negri Sud
• Investigators: Principal Investigator: Andrea Gallamini, MD, Azienda Sanitaria Ospedaliera Santa Croce e Carle Cuneo

Publications and helpful links

General Publications

• 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. doi: 10.1200/JCO.2007.11.6525. Epub 2007 Jul 23.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): October 1, 2015
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: July 21, 2011
• First Submitted That Met QC Criteria: July 21, 2011
• First Posted (Estimate): July 22, 2011

Study Record Updates

• Last Update Posted (Estimate): October 19, 2015
• Last Update Submitted That Met QC Criteria: October 16, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Early stage
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease
• Other Study ID Numbers: 2P-HD-10 STUDY