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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

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, MDPrincipal Investigator

ANDREA GALLAMINI, MDPh: +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 LevisPrincipal 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, MDPrincipal Investigator
  Genova
 Ospedale San Martino
 ANGELO M CARELLA, MD Ph: +39010513731
  Email: angelomichele.carella@hsmartino.it
 Angelo Michele CarellaPrincipal Investigator
  Messina
 Azienda Ospedaliera Papardo
 DONATO MANNINA, MD Ph: +390903992253
  Email: d.mannina@alice.it
 DONATO MANNINA, MDPrincipal Investigator
  Monza
 Ospedale San Gerardo
 SILVIA BOLIS, MD Ph: +390392339383
  Email: s.bolis@hsgerardo.org
 SILVIA BOLIS, MDPrincipal Investigator
  Torino
 Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
 PAOLO GAVAROTTI, MD Ph: +393479632795
  Email: pgavarotti@molinette.piemonte.it
 PAOLO GAVAROTTI, MDPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01399931
ClinicalTrials.gov processed this data on October 20, 2014

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.

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