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Completed

NCT Number: NCT03469102

18FDG PET Textural Indices in Adrenal Lesion

Tumors are characterized by a great heterogeneity. Characterizing this intra-tumor heterogeneity is a major challenge in oncology to improve the therapeutic management and move towards personalized medicine adapted to each patient. However, intra-tumor heterogeneity remains rarely used for diagnostic purposes The discovery of an adrenal mass can occur in different circumstances. Detection of an adrenal mass can be done in a context of secreting syndrome, in the assessment of an extra-adrenal neoplasia or fortuitously when performing an imaging for another reason. The etiologies are numerous (cortical tumors, medullary tumors, metastatic lesion of a extra-adrenal neoplasia, others). The adrenal masses can be divided into two categories, depending on whether they are hyperfunctional or not. In patients without an oncological history, an adrenal mass discovered is most often a benign adenoma, but requires an endocrine assessment. In patients with known primary cancer, approximately 30% of the adrenal masses are malignant.

In all cases, the diagnostic procedure includes an imaging assessment to characterize the lesion and an endocrine assessment. CT scan performed without and after intravenous iodinated contrast agent injection is the first-line examination to assess an adrenal mass.

18F-FDG-PET may be indicated as second-line for characterizing an adrenal mass. Adrenal tumor SUVmax (Standard Uptake Value) and adrenal tumor SUVmax / liver SUVmax ratio are routinely used to determine the malignancy of a lesion. Although very useful for assessing the glucose metabolism of a given lesion, these parameters do not allow assessing the heterogeneity of tumor uptake. The texture analysis corresponds to an analysis of the spatial distribution of FDG uptake, and allows, by the calculation of many indices, an evaluation of the heterogeneity of the tumors.

The hypothesis of our study is that the texture parameters could have an additional diagnostic value to improve the performance of conventional quantitative parameters to determine the malignancy of a lesion.

The objective of this study is to investigate the diagnostic value of texture indices in a large cohort of patients presenting an adrenal lesion

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest

Brest, 29609, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having benefited from a 18-FDG PET-CT scan in the nuclear medicine department of University Hospital of Brest
  • Addressed in the context of an assessment of an adrenal lesion, in the evaluation of an extra-adrenal neoplasia or other motive
  • presenting an adrenal lesion
  • From June 29, 2012 to June 30, 2017

Exclusion criteria

  • Patients followed in another center than the University Hospital of Brest
  • Lesions of undetermined nature
  • Diagnosis of benignity or malignancy not confirmed by anatomopathology.
  • Patient having expressed his opposition to the use of his medical data

Treatment and study plan

Primary outcomes

  1. Diagnostic performance of FDG PET/CT textural indices

    Time frame: 6 months

    Area Under the Curve

Secondary outcomes

  1. Cut off value of FDG PET/CT textural indices

    Time frame: 6 months

    For each cut off value : Sensibility(%)

  2. Cut off value of FDG PET/CT textural indices

    Time frame: 6 months

    For each cut off value : Specificity(%)

  3. Cut off value of FDG PET/CT textural indices

    Time frame: 6 months

    For each cut off value : Positive and Negative Predictive Value (%),

  4. Cut off value of FDG PET/CT textural indices

    Time frame: 6 months

    For each cut off value : Accuracy (%)

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Diagnostic Value of 18FDG PET/CT Textural Indices in Patients With an Adrenal Lesion

Acronym: ImpactTexture

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 19, 2018
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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