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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Ospedale Santa Croce-Carle Cuneo
Sponsor:
Collaborators:
Consorzio Mario Negri Sud
Fondazione Italiana Linfomi ONLUS
Information provided by (Responsible Party):
DR. ANDREA GALLAMINI, Ospedale Santa Croce-Carle Cuneo
ClinicalTrials.gov Identifier:
NCT01399931
First received: July 21, 2011
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

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.


Condition
Hodgkin's Lymphoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dual Point Acquisition in the Interim Pet Scan Performed During ABVD Treatment, in Early-Stage Hodgkin's Lymphoma Patients With Bulky Lesions

Resource links provided by NLM:


Further study details as provided by Ospedale Santa Croce-Carle Cuneo:

Primary Outcome Measures:
  • Event free survival (EFS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Evaluation of inflammation markers prognostic role [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 150
Study Start Date: January 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Early-stage Hodgkin Lymphoma Patients
Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions treated with ABVD and consolidation radiotherapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399931

Contacts
Contact: ANDREA GALLAMINI, MD +390171642414 gallamini.a@ospedale.cuneo.it
Contact: MARIA ROSARIA MENNITTO, PHARM D +390171642415 mennitto.m@ospedale.cuneo.it

Locations
Italy
Ospedale Santi Antonio E Biagio E Cesare Arrigo Recruiting
Alessandria, AL, Italy, 15100
Contact: ALESSANDRO LEVIS, MD    +390131206156    alevis@ospedale.al.it   
Principal Investigator: ALESSANDRO LEVIS, MD         
Azienda Ospedaliera Universitaria S. Martino Recruiting
Genova, GE, Italy, 16132
Contact: ANGELO M CARELLA, MD    +39010513731    angelomichele.carella@hsmartino.it   
Principal Investigator: ANGELO M CARELLA, MD         
Azienda Ospedaliera S. Gerardo Recruiting
Monza, MB, Italy, 20900
Contact: SILVIA BOLIS, MD    +390392339383    s.bolis@hsgerardo.org   
Principal Investigator: SILVIA BOLIS, MD         
Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte Recruiting
Messina, ME, Italy, 98158
Contact: DONATO MANNINA, MD    +390903992253    d.mannina@alice.it   
Principal Investigator: DONATO MANNINA, MD         
Azienda Ospedaliera S. Giovanni Battista Recruiting
Torino, TO, Italy, 10126
Contact: PAOLO GAVAROTTI, MD    +393479632795    pgavarotti@molinette.piemonte.it   
Principal Investigator: PAOLO GAVAROTTI, MD         
Azienda Sanitaria Ospedaliera S. Croce E Carle Recruiting
Cuneo, Italy, 12100
Contact: ANDREA GALLAMINI, MD    +390171642414    gallamini.a@ospedale.cuneo.it   
Contact: ALBERTO BIGGI, MD    00390171641558    biggi.a@ospedale.cuneo.it   
Principal Investigator: Andrea Gallamini, MD         
Sponsors and Collaborators
Ospedale Santa Croce-Carle Cuneo
Consorzio Mario Negri Sud
Fondazione Italiana Linfomi ONLUS
Investigators
Principal Investigator: Andrea Gallamini, MD Azienda Sanitaria Ospedaliera Santa Croce e Carle Cuneo
  More Information

No publications provided

Responsible Party: DR. ANDREA GALLAMINI, HEAD OF HAEMATOLOGY DEPT. A.S.O. S. CROCE AND CARLE, Ospedale Santa Croce-Carle Cuneo
ClinicalTrials.gov Identifier: NCT01399931     History of Changes
Other Study ID Numbers: 2P-HD-10 STUDY
Study First Received: July 21, 2011
Last Updated: February 2, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Ospedale Santa Croce-Carle Cuneo:
Early stage

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014