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18FDG PET Textural Indices in Adrenal Lesion (ImpactTexture)

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ClinicalTrials.gov Identifier: NCT03469102
Recruitment Status : Completed
First Posted : March 19, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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


Condition or disease
Adrenal Tumor

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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Diagnostic Value of 18FDG PET/CT Textural Indices in Patients With an Adrenal Lesion
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 27, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Diagnostic performance of FDG PET/CT textural indices [ Time Frame: 6 months ]
    Area Under the Curve


Secondary Outcome Measures :
  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 (%)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
presenting an adrenal lesion
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469102


Locations
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France
CHRU de Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03469102     History of Changes
Other Study ID Numbers: Impact Texture Surrénale
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Brest:
Positron emission tomography
Texture indices
Diagnostic performance
Additional relevant MeSH terms:
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Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adrenal Gland Diseases
Endocrine System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Fluorodeoxyglucose F18
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Radiopharmaceuticals