18FDG PET Textural Indices in Adrenal Lesion (ImpactTexture)

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

Study Overview

• Status: Completed
• Conditions: Adrenal Tumor

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

presenting an adrenal lesion

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance of FDG PET/CT textural indices	Area Under the Curve	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cut off value of FDG PET/CT textural indices	For each cut off value : Sensibility(%)	6 months
Cut off value of FDG PET/CT textural indices	For each cut off value : Specificity(%)	6 months
Cut off value of FDG PET/CT textural indices	For each cut off value : Positive and Negative Predictive Value (%),	6 months
Cut off value of FDG PET/CT textural indices	For each cut off value : Accuracy (%)	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 27, 2018

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Positron emission tomography; Diagnostic performance; Texture indices
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Adrenal Gland Diseases; Adrenal Gland Neoplasms
• Other Study ID Numbers: Impact Texture Surrénale

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No