Adrenal TumorImpactTextureNCT03469102
18FDG PET Textural Indices in Adrenal Lesion
An observational study of Adrenal Tumor, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenal Tumor
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2018to 27 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: presenting an adrenal lesion
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Adrenal Gland Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of FDG PET/CT textural indices
Area Under the Curve
Measured: 6 months
Secondary outcomes (4)
Cut off value of FDG PET/CT textural indices
For each cut off value : Sensibility(%)
Measured: 6 months
Cut off value of FDG PET/CT textural indices
For each cut off value : Specificity(%)
Measured: 6 months
Cut off value of FDG PET/CT textural indices
For each cut off value : Positive and Negative Predictive Value (%),
Measured: 6 months
Cut off value of FDG PET/CT textural indices
For each cut off value : Accuracy (%)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start1 Mar 2018
- Primary completion1 Jul 2018
- Study completion27 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal TumorStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469102
- Sponsor's protocol ID
- Impact Texture Surrénale
- Acronym
- ImpactTexture
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of 18FDG PET/CT Textural Indices in Patients With an Adrenal Lesion
- ClinicalTrials.gov ID
- NCT03469102
- Acronym / sponsor ID
- ImpactTexture / Impact Texture Surrénale
- Conditions
- Adrenal Tumor
- Keywords
- Positron emission tomography, Texture indices, Diagnostic performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- presenting an adrenal lesion
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance of FDG PET/CT textural indices
Time frame: 6 months
Area Under the Curve
4 secondary outcomes
Cut off value of FDG PET/CT textural indices
Time frame: 6 months
Cut off value of FDG PET/CT textural indices
Time frame: 6 months
Cut off value of FDG PET/CT textural indices
Time frame: 6 months
Cut off value of FDG PET/CT textural indices
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Tumor, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of FDG PET/CT textural indices (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.