Dual Point PET Scan in Early Stage Hodgkin Lymphoma Patients With Bulky Lesions (2P-HD-10)
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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 |
- 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.
- 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 |
|---|
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Early-stage Hodgkin Lymphoma Patients
Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions treated with ABVD and consolidation radiotherapy
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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 |
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)
Contacts and Locations| Contact: ANDREA GALLAMINI, MD | +390171642414 | gallamini.a@ospedale.cuneo.it |
| Contact: MARIA ROSARIA MENNITTO, PHARM D | +390171642415 | mennitto.m@ospedale.cuneo.it |
| 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 | |
| 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 May 21, 2013