Hodgkin's Lymphoma2P-HD-10NCT01399931
Dual Point PET Scan in Early Stage Hodgkin Lymphoma Patients With Bulky Lesions
An observational study of Hodgkin's Lymphoma, run by Ospedale Santa Croce-Carle Cuneo at 6 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hodgkin's Lymphoma
- How many people
- 150 participants
- Where
- 6 sitesItaly
- Study dates
- Jan 2012to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions.
Who may be able to join
- 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
Who cannot join
- Diabetes mellitus uncompensated
- Lymphocyte predominance histology
- Pregnancy or lactation
- Implanted biomedical devices (for DW-MRI sub study)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites, 6 recruiting
- Recruiting
Ospedale Santi Antonio E Biagio E Cesare Arrigo
Alessandria, AL, 15100
ALESSANDRO LEVIS, MD, +390131206156, alevis@ospedale.al.it
ALESSANDRO LEVIS, MD
- Recruiting
Azienda Sanitaria Ospedaliera S. Croce E Carle
Cuneo, Cuneo, 12100
ANDREA GALLAMINI, MD, +390171642414, gallamini.a@ospedale.cuneo.it
ALBERTO BIGGI, MD, 00390171641558, biggi.a@ospedale.cuneo.it
- Recruiting
Azienda Ospedaliera Universitaria S. Martino
Genova, GE, 16132
ANGELO M CARELLA, MD, +39010513731, angelomichele.carella@hsmartino.it
ANGELO M CARELLA, MD
- Recruiting
Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte
Messina, ME, 98158
DONATO MANNINA, MD, +390903992253, d.mannina@alice.it
DONATO MANNINA, MD
- Recruiting
Azienda Ospedaliera S. Gerardo
Monza, MB, 20900
SILVIA BOLIS, MD, +390392339383, s.bolis@hsgerardo.org
SILVIA BOLIS, MD
- Recruiting
Azienda Ospedaliera S. Giovanni Battista
Torino, TO, 10126
PAOLO GAVAROTTI, MD, +393479632795, pgavarotti@molinette.piemonte.it
PAOLO GAVAROTTI, MD
About this study
Official title: Dual Point Acquisition in the Interim Pet Scan Performed During ABVD Treatment, in Early-Stage Hodgkin's Lymphoma Patients With Bulky Lesions
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.
Read the 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.
- Conditions
- Hodgkin's Lymphoma
- Keywords
- Early stage
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early-stage Hodgkin Lymphoma Patients | Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions treated with ABVD and consolidation radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival (EFS)
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.
Measured: 1 year
Secondary outcomes (1)
Evaluation of inflammation markers prognostic role
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startJan 2012
- Primary completionOct 2015 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Santa Croce-Carle Cuneo
- Sponsor type
- University, hospital or other
- Collaborators
- Consorzio Mario Negri Sud, Fondazione Italiana Linfomi - ETS
- Responsible party
- Principal investigator, DR. ANDREA GALLAMINI, Ospedale Santa Croce-Carle Cuneo
- Investigators
- Andrea Gallamini, MD, Principal investigator, Azienda Sanitaria Ospedaliera Santa Croce e Carle Cuneo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399931
- Sponsor's protocol ID
- 2P-HD-10 STUDY
- Acronym
- 2P-HD-10
- Status last verified
- Oct 2015
- First submitted
- 21 Jul 2011
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gallamini A.:Positron emission tomography scanning: a new paradigm for the management of Hodgkin's lymphoma. Haematologica 2010;95, 1-3 Gallamini A, Rigacci L, Merli F, Nassi L, Bosi A, Capodanno I, et al. The predictive value of positron emission tomography scanning performed after two courses of standard therapy on treatment outcome in advanced stage Hodgkin's disease. Haematologica 2006 Apr;91(4):475-81. Meignan M, Itti E, Gallamini A, Haioun C. Interim 18F-fluorodeoxyglucose positron emission tomography in diffuse large B-cell lymphoma: qualitative or quantitative interpretation - where do we stand? Leukemia & Lymphoma 2009; 50(11) 1753-56. Gallamini A, Hutchings M, Rigacci L, Specht L, Merli F, Hansen M, et al. Early interim 2-[18F]fluoro-2-deoxy-D-glucose positron emission tomography is prognostically superior to international prognostic score in advanced-stage Hodgkin's lymphoma: a report from a joint Italian-Danish study. J Clin Oncol 2007 Aug 20;25(24):3746-52.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Point Acquisition in the Interim Pet Scan Performed During ABVD Treatment, in Early-Stage Hodgkin's Lymphoma Patients With Bulky Lesions
- ClinicalTrials.gov ID
- NCT01399931
- Acronym / sponsor ID
- 2P-HD-10 / 2P-HD-10 STUDY
- Conditions
- Hodgkin's Lymphoma
- Keywords
- Early stage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ospedale Santa Croce-Carle CuneoUniversity, hospital or other
- Collaborators
- Consorzio Mario Negri Sud, Fondazione Italiana Linfomi - ETS
- Study start
- Jan 2012
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early-stage Hodgkin Lymphoma Patients | – | –Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions treated with ABVD and consolidation radiotherapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- Diabetes mellitus uncompensated
- Lymphocyte predominance histology
- Pregnancy or lactation
- Implanted biomedical devices (for DW-MRI sub study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Evaluation of inflammation markers prognostic role
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- BackgroundGallamini A.:Positron emission tomography scanning: a new paradigm for the management of Hodgkin's lymphoma. Haematologica 2010;95, 1-3 Gallamini A, Rigacci L, Merli F, Nassi L, Bosi A, Capodanno I, et al. The predictive value of positron emission tomography scanning performed after two courses of standard therapy on treatment outcome in advanced stage Hodgkin's disease. Haematologica 2006 Apr;91(4):475-81. Meignan M, Itti E, Gallamini A, Haioun C. Interim 18F-fluorodeoxyglucose positron emission tomography in diffuse large B-cell lymphoma: qualitative or quantitative interpretation - where do we stand? Leukemia & Lymphoma 2009; 50(11) 1753-56. Gallamini A, Hutchings M, Rigacci L, Specht L, Merli F, Hansen M, et al. Early interim 2-[18F]fluoro-2-deoxy-D-glucose positron emission tomography is prognostically superior to international prognostic score in advanced-stage Hodgkin's lymphoma: a report from a joint Italian-Danish study. J Clin Oncol 2007 Aug 20;25(24):3746-52.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Gallamini, MD principal investigator
Azienda Sanitaria Ospedaliera Santa Croce e Carle Cuneo
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin's Lymphoma, run by Ospedale Santa Croce-Carle Cuneo at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANDREA GALLAMINI, MD (+390171642414, gallamini.a@ospedale.cuneo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event free survival (EFS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01399931, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.