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

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedDiagnosticActive18 to 60Other2P-HD-10 STUDY
NCT01399931

Trial Description

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.

Further Study Information

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.

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)

Trial Contact Information

Trial Lead Organizations/Sponsors

Ospedale Santa Croce

  • Consorzio Mario Negri Sud
  • Fondazione Intergruppo Italiano Linfomi Onlus
Andrea Gallamini, MD, Principal Investigator
ANDREA GALLAMINI, MD
Ph: +390171642414
Email: gallamini.a@ospedale.cuneo.it

Trial Sites

Italy

Alessandria

Ospedale SS. Biagio e Arrigo

ALESSANDRO LEVIS, MD
Ph: +390131206156
Email: alevis@ospedale.al.it

Alessandro Levis
Principal Investigator

Cuneo

Ospedale Santa Croce

ANDREA GALLAMINI, MD
Ph: +390171642414
Email: gallamini.a@ospedale.cuneo.it

ALBERTO BIGGI, MD
Ph: 00390171641558
Email: biggi.a@ospedale.cuneo.it

Andrea Gallamini, MD
Principal Investigator

Genova

Ospedale San Martino

ANGELO M CARELLA, MD
Ph: +39010513731
Email: angelomichele.carella@hsmartino.it

Angelo Michele Carella
Principal Investigator

Messina

Azienda Ospedaliera Papardo

DONATO MANNINA, MD
Ph: +390903992253
Email: d.mannina@alice.it

DONATO MANNINA, MD
Principal Investigator

Monza

Ospedale San Gerardo

SILVIA BOLIS, MD
Ph: +390392339383
Email: s.bolis@hsgerardo.org

SILVIA BOLIS, MD
Principal Investigator

Torino

Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

PAOLO GAVAROTTI, MD
Ph: +393479632795
Email: pgavarotti@molinette.piemonte.it

PAOLO GAVAROTTI, MD
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01399931
ClinicalTrials.gov processed this data on April 09, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.