18FDG PET Textural Indices in Adrenal Lesion

NCT03469102 | Completed

• 1 other identifier: Impact Texture Surrénale
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adrenal Tumor

Keywords

Positron emission tomography; Texture indices; Diagnostic performance

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of FDG PET/CT textural indices

  Area Under the Curve

  6 months

Secondary Outcomes (4)

• Cut off value of FDG PET/CT textural indices

  6 months

• Cut off value of FDG PET/CT textural indices

  6 months

• Cut off value of FDG PET/CT textural indices

  6 months

• Cut off value of FDG PET/CT textural indices

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

presenting an adrenal lesion

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Adrenal Gland Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adrenal Gland Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 19, 2018
• Study Start: March 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: July 27, 2018
• Last Updated: July 30, 2018

Record last verified: 2018-03

Locations

FR (1)