Prognostic Value of 18FDG PET/CT Textural Indices in HNSCC (ImpactTextureO)

July 20, 2018 updated by: University Hospital, Brest

Prognostic Value of Textural Indices Extracted From Pre-therapeutic 18-F FDG PET/CT in Head and Neck Squamous Cell Carcinoma.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
284

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHRU de Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients referred for a pre-treatment FDG PET/CT of biopsy proven HSNCC

Description

Inclusion Criteria:

  • biopsy proven HSNCC
  • written consent

Exclusion Criteria:

  • previous head and neck malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prognostic value of FDG PET/CT textural indices
Time Frame: 2 years
Overall survival
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ImpactTextureORL 29BRC17.0190

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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