Know Cancer

or
forgot password

Dual Point Acquisition in the Interim Pet Scan Performed During ABVD Treatment, in Early-Stage Hodgkin's Lymphoma Patients With Bulky Lesions


N/A
18 Years
60 Years
Open (Enrolling)
Both
Hodgkin's Lymphoma

Thank you

Trial Information

Dual Point Acquisition in the Interim Pet Scan Performed During ABVD Treatment, in Early-Stage Hodgkin's Lymphoma Patients With Bulky Lesions


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.


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)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Event free survival (EFS)

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Andrea Gallamini, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Azienda Sanitaria Ospedaliera Santa Croce e Carle Cuneo

Authority:

Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:

2P-HD-10 STUDY

NCT ID:

NCT01399931

Start Date:

January 2012

Completion Date:

January 2017

Related Keywords:

  • Hodgkin's Lymphoma
  • Early stage
  • Hodgkin Disease
  • Lymphoma

Name

Location