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CompletedNCT03469102ImpactTextureUpdated Jul 30, 2018

18FDG PET Textural Indices in Adrenal Lesion

An observational study in Adrenal Tumor, sponsored by University Hospital, Brest. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-30.

Sponsored by University Hospital, Brest · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
53
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Adrenal Tumor

Keywords

  • Positron emission tomography
  • Texture indices
  • Diagnostic performance
03

In context

Adrenal Gland Neoplasms

62 studies on the registry are indexed under Adrenal Gland Neoplasms; 19 are open to participants now.

This study's enrollment of 53 is below the median of 300 across 27 observational studies indexed under Adrenal Gland Neoplasms.

Browse Adrenal Gland Neoplasms studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

presenting an adrenal lesion

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients followed in another center than the University Hospital of Brest
  • Lesions of undetermined nature
  • Diagnosis of benignity or not confirmed by anatomopathology.
  • Patient having expressed his opposition to the use of his medical data
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
53 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Diagnostic performance of FDG PET/CT textural indices

    Area Under the Curve

    Time frame: 6 months

Secondary outcomes

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

    For each cut off value : Sensibility(%)

    Time frame: 6 months

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

    For each cut off value : Specificity(%)

    Time frame: 6 months

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

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

    Time frame: 6 months

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

    For each cut off value : Accuracy (%)

    Time frame: 6 months

07

Study locations

1 site
  • CHRU de Brest
    Brest, 29609, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Jul 2018, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2018
First posted
Mar 19, 2018
StartActual
Mar 1, 2018
Primary completionActual
Jul 1, 2018
CompletionActual
Jul 27, 2018
Last update
Jul 30, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03469102
Responsible party
Sponsor
First posted
Mar 19, 2018
Start date
Mar 1, 2018
Primary completion
Jul 1, 2018
Completion
Jul 27, 2018
Last update
Jul 30, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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