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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01399931
Recruitment Status : Unknown
Verified October 2015 by DR. ANDREA GALLAMINI, Ospedale Santa Croce-Carle Cuneo.
Recruitment status was:  Recruiting
First Posted : July 22, 2011
Last Update Posted : October 19, 2015
Consorzio Mario Negri Sud
Fondazione Italiana Linfomi ONLUS
Information provided by (Responsible Party):
DR. ANDREA GALLAMINI, Ospedale Santa Croce-Carle Cuneo

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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 150 participants
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
Study Start Date : January 2012
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Event free survival (EFS) [ Time Frame: 1 year ]
    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 :
  1. Evaluation of inflammation markers prognostic role [ Time Frame: 3 years ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01399931

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Contact: ANDREA GALLAMINI, MD +390171642414
Contact: MARIA ROSARIA MENNITTO, PHARM D +390171642415

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Ospedale Santi Antonio E Biagio E Cesare Arrigo Recruiting
Alessandria, AL, Italy, 15100
Contact: ALESSANDRO LEVIS, MD    +390131206156   
Principal Investigator: ALESSANDRO LEVIS, MD         
Azienda Ospedaliera Universitaria S. Martino Recruiting
Genova, GE, Italy, 16132
Contact: ANGELO M CARELLA, MD    +39010513731   
Principal Investigator: ANGELO M CARELLA, MD         
Azienda Ospedaliera S. Gerardo Recruiting
Monza, MB, Italy, 20900
Contact: SILVIA BOLIS, MD    +390392339383   
Principal Investigator: SILVIA BOLIS, MD         
Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte Recruiting
Messina, ME, Italy, 98158
Contact: DONATO MANNINA, MD    +390903992253   
Principal Investigator: DONATO MANNINA, MD         
Azienda Ospedaliera S. Giovanni Battista Recruiting
Torino, TO, Italy, 10126
Contact: PAOLO GAVAROTTI, MD    +393479632795   
Principal Investigator: PAOLO GAVAROTTI, MD         
Azienda Sanitaria Ospedaliera S. Croce E Carle Recruiting
Cuneo, Italy, 12100
Contact: ANDREA GALLAMINI, MD    +390171642414   
Contact: ALBERTO BIGGI, MD    00390171641558   
Principal Investigator: Andrea Gallamini, MD         
Sponsors and Collaborators
Ospedale Santa Croce-Carle Cuneo
Consorzio Mario Negri Sud
Fondazione Italiana Linfomi ONLUS
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Principal Investigator: Andrea Gallamini, MD Azienda Sanitaria Ospedaliera Santa Croce e Carle Cuneo

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Responsible Party: DR. ANDREA GALLAMINI, HEAD OF HAEMATOLOGY DEPT. A.S.O. S. CROCE AND CARLE, Ospedale Santa Croce-Carle Cuneo Identifier: NCT01399931    
Other Study ID Numbers: 2P-HD-10 STUDY
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: October 19, 2015
Last Verified: October 2015
Keywords provided by DR. ANDREA GALLAMINI, Ospedale Santa Croce-Carle Cuneo:
Early stage
Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases