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NCT01399931 · CITED IN SOURCE DOCUMENTS

Dual Point PET Scan in Early Stage Hodgkin Lymphoma Patients With Bulky Lesions

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
Not reported
Status at capture
UNKNOWN
Registry last update
2015-10-19

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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)
healthy Volunteers
false
maximum Age
60 Years
minimum Age
18 Years
sampling Method
NON_PROBABILITY_SAMPLE
sex
ALL
std Ages
  1. ADULT
study Population
Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions.
Treatment arms and interventions
arm Groups
  1. description
    Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions treated with ABVD and consolidation radiotherapy
    label
    Early-stage Hodgkin Lymphoma Patients
Study design
observational Model
COHORT
time Perspective
PROSPECTIVE
Enrollment
count
150
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. 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.
    measure
    Event free survival (EFS)
    time Frame
    1 year
secondary Outcomes
  1. description
    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
    measure
    Evaluation of inflammation markers prognostic role
    time Frame
    3 years
Full study description
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.
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.
Source references
references
  1. citation
    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.
    type
    BACKGROUND
Source notices and limitations
    Discovery and provenance
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        o the survival reported at 11 years in the GHSG's <a href="/clinicaltrials/NCT02495922">HD6</a> (NCT00002561), <a href="/clinicaltrials/NCT00265018">HD10</a> (NCT01399931), and <a href="/clinicaltrials/NCT00264953">HD11</a> (NCT0264953) trials using combined-modality therapy.[<a href="#cit/section_6.10">10</a>] In addition, for
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      source title
      Hodgkin Lymphoma Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: February 12, 2025
        datetime
        2025-02-12T12:00:00Z
        display
        February 12, 2025

    Preserved source evidence · Not medical advice