Cancer of Head and Neck Clinical Trial
— ImpactTextureOOfficial title:
Prognostic Value of Textural Indices Extracted From Pre-therapeutic 18-F FDG PET/CT in Head and Neck Squamous Cell Carcinoma.
| Verified date | November 2017 |
| Source | University Hospital, Brest |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Head and neck (HN) cancer is the sixth most common malignancy worldwide, with around 800,000
new cases and 320,000 deaths in 2015. These malignancies encompass cancers of the oral
cavity, oropharynx, hypopharynx and larynx and concerned squamous cell carcinomas (SCC) 90%
of the time.
Despite aggressive treatment strategies, the five-year survival rate has only marginally
improved in the past decade especially because of a high rate (up to 40%) of loco-regional
recurrence. Moreover, two-third of local relapse and lymph node metastases occur in the first
2 years after treatment. Hence, predicting tumor response to therapy remains a real challenge
in head and neck cancers.
Usual prognostic factors include the tumor size, the lymph node involvement, the presence of
distant metastasis, the anatomic subsite, and the human papilloma virus (HPV 16, 18)
infection status. However, pre-treatment selection of patients with poor prognosis or who
require intensified therapy remains difficult despite their careful evaluation.
HNSCC also present a high biologic heterogeneity with hypoxic area, necrotic regions, zones
of high cellular proliferation and intra-tumoral angiogenic heterogeneity. A better
characterization of tumor heterogeneity could help classify patients in different risk
subgroups in order to improve their therapeutic management.
Pre-therapeutic 18F-fluorodeoxyglucose positron-emission tomography (FDG PET/CT) is
recommended by guidelines to assess remote extension of locally advanced HNSCC and/or to look
for synchronous cancer. Its prognostic significance has already been suggested and a
selection of patients at risk of recurrence appears possible using different quantitative
parameters. Indeed, static (SUV = Standardized Uptake Value), volumetric (MTV = Metabolic
Tumor Volume, TLG = Total Lesion Glycolysis) and kinetic (RI = Retention Index) parameters
were demonstrated to be independent prognostic factors in several studies.
Texture analysis is currently highly studied in order to characterize tumor heterogeneity,
and consists in extracting texture indices from different imaging modalities such as FDG
PET/CT. Calculating texture indices relies on choosing a contouring method to delineate a
tumor volume of interest and selecting several parameters such as the resampling method,
matrix definitions and indices formula. Several studies conducted on small series of patients
with HNSCC have showed promising results to predict survival, analyzing various cancer
anatomic subsites, tumor segmentation methods and texture indices.
The objective of this study is to assess the prognostic value of texture indices in a large
cohort of patients with HSNCC, including any anatomic subtype and staging.
| Status | Completed |
| Enrollment | 284 |
| Est. completion date | March 30, 2018 |
| Est. primary completion date | March 30, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - biopsy proven HSNCC - written consent Exclusion Criteria: - previous head and neck malignancy |
| Country | Name | City | State |
|---|---|---|---|
| France | CHRU de Brest | Brest |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Brest |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prognostic value of FDG PET/CT textural indices | Overall survival | 2 years |
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