Adrenal TumorsNCT01284829
Performance of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Diagnosis of Indeterminate Adrenal Tumors on Conventional Imaging: A French Prospective Multicentric Study
A study testing FDG-PET scan in people with Adrenal Tumors, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
This is a prospective study which aims to validate a new diagnostic approach in the tissue characterization of adrenal tumors indeterminate on conventional imaging. For this purpose, it is not necessary to have a control group since the diagnostic accuracy in a well defined subset of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenal Tumors
- What is being tested?
- FDG-PET scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2011to 5 Apr 2023
- Phase
- Interventional
- 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
Who may be able to join
- Adult ≥ 18 yrs, male or female;
- Indeterminate adrenal tumor (6.3.1.). The CT must include the calculation of SD and contrast washout and should have been performed within the 30 days before the inclusion visit (visit 0) ;
- Patient insured with public health care system ;
- Patient who accept to participate to the study and to sign the consent document form.
Who cannot join
- Technical inability to perform FDG-PET.
- Patient's death before final diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective study which aims to validate a new diagnostic approach in the tissue characterization of adrenal tumors indeterminate on conventional imaging. For this purpose, it is not necessary to have a control group since the diagnostic accuracy in a well defined subset of patients.
Visit 0 : Enrollment, eligibility. Visit 1 : FDG-PET. Visit 2 : Postoperative visit. Visit 3 : 6 months post-PET. Visit 4 : 12 months post-PET.
Read the detailed description
Primary objective The primary objective is to assess the diagnostic accuracy of FDG-PET, particularly the SUVmax tumor/liver ratio, in the diagnosis of indeterminate adrenal tumors on conventional imaging.
Secondary objectives
- To assess the diagnostic accuracy of the tumor SUVmax, and SUVmax of the tumor/mean SUV of the liver.
- To evaluate the relationship between SUVmax tumor/liver ratio and Weiss score.
- To evaluate the impact of the use of FDG-PET on the treatment options.
- To evaluate the economic impact of FDG-PET in the management of indeterminate adrenal tumors (ancillary study).
- Conditions
- Adrenal Tumors
- Being tested
- FDG-PET scan
- Medical subject headings
- Adrenal Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG-PET scanOther
| Study group | Role | What they receive |
|---|---|---|
| adrenal tumors | Experimental | adrenal tumors Receives: Other: FDG-PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy of FDG-PETparticularly the SUVmax tumor/liver ratio, in the diagnosis of indeterminate adrenal tumors on conventional imaging.
Measured: 3 YEARS
Secondary outcomes (4)
assess the diagnostic accuracy of the tumorSUVmax, and SUVmax of the tumor/mean SUV of the liver.
Measured: 3 YEARS
To evaluate the relationship between SUVmax tumor/liver ratio and Weiss score
Measured: 3 years
To evaluate the impact of the use of FDG-PET on the treatment options
Measured: 3 years
To evaluate the economic impact of FDG-PET in the management of indeterminate adrenal tumors (ancillary study).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study start4 Feb 2011
- Primary completion10 Oct 2013
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adrenal TumorsStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DAVID TAEB, Principal investigator, Assistance Publique hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284829
- Sponsor's protocol ID
- 2010-A00705-34
- Other IDs
- 2010 08
- Status last verified
- Apr 2023
- First submitted
- 13 Jan 2011
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Guerin C, Pattou F, Brunaud L, Lifante JC, Mirallie E, Haissaguerre M, Huglo D, Olivier P, Houzard C, Ansquer C, Hindie E, Loundou A, Archange C, Tabarin A, Sebag F, Baumstarck K, Taieb D. Performance of 18F-FDG PET/CT in the Characterization of Adrenal Masses in Noncancer Patients: A Prospective Study. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2465-2472. doi: 10.1210/jc.2017-00254.
PubMed 28431167
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Diagnosis of Indeterminate Adrenal Tumors on Conventional Imaging: A French Prospective Multicentric Study
- ClinicalTrials.gov ID
- NCT01284829
- Acronym / sponsor ID
- 2010-A00705-34
- Conditions
- Adrenal Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 4 Feb 2011 (actual)
- Primary completion
- 10 Oct 2013 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 27 Jan 2011 (estimated)
- 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.
This is a prospective study which aims to validate a new diagnostic approach in the tissue characterization of adrenal tumors indeterminate on conventional imaging. For this purpose, it is not necessary to have a control group since the diagnostic accuracy in a well defined subset of patients.
Visit 0 : Enrollment, eligibility. Visit 1 : FDG-PET. Visit 2 : Postoperative visit. Visit 3 : 6 months post-PET. Visit 4 : 12 months post-PET.
Detailed description
Primary objective The primary objective is to assess the diagnostic accuracy of FDG-PET, particularly the SUVmax tumor/liver ratio, in the diagnosis of indeterminate adrenal tumors on conventional imaging.
Secondary objectives
- To assess the diagnostic accuracy of the tumor SUVmax, and SUVmax of the tumor/mean SUV of the liver.
- To evaluate the relationship between SUVmax tumor/liver ratio and Weiss score.
- To evaluate the impact of the use of FDG-PET on the treatment options.
- To evaluate the economic impact of FDG-PET in the management of indeterminate adrenal tumors (ancillary study).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adrenal tumors | Experimental | Other: FDG-PET scanadrenal tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult ≥ 18 yrs, male or female;
- Indeterminate adrenal tumor (6.3.1.). The CT must include the calculation of SD and contrast washout and should have been performed within the 30 days before the inclusion visit (visit 0) ;
- Patient insured with public health care system ;
- Patient who accept to participate to the study and to sign the consent document form.
Key exclusion criteria (2 listed)
- Technical inability to perform FDG-PET.
- Patient's death before final diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDG-PET scan | Other | adrenal tumors |
Primary outcome
diagnostic accuracy of FDG-PETparticularly the SUVmax tumor/liver ratio, in the diagnosis of indeterminate adrenal tumors on conventional imaging.
Time frame: 3 YEARS
4 secondary outcomes
assess the diagnostic accuracy of the tumorSUVmax, and SUVmax of the tumor/mean SUV of the liver.
Time frame: 3 YEARS
To evaluate the relationship between SUVmax tumor/liver ratio and Weiss score
Time frame: 3 years
To evaluate the impact of the use of FDG-PET on the treatment options
Time frame: 3 years
To evaluate the economic impact of FDG-PET in the management of indeterminate adrenal tumors (ancillary study).
Time frame: 3 years
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 6 Apr 2023.
- Derived from this study: PubMed 28431167Guerin C, Pattou F, Brunaud L, Lifante JC, Mirallie E, Haissaguerre M, Huglo D, Olivier P, Houzard C, Ansquer C, Hindie E, Loundou A, Archange C, Tabarin A, Sebag F, Baumstarck K, Taieb D. Performance of 18F-FDG PET/CT in the Characterization of Adrenal Masses in Noncancer Patients: A Prospective Study. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2465-2472. doi: 10.1210/jc.2017-00254.
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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.
DAVID TAEB principal investigator
Assistance Publique hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDG-PET scan in people with Adrenal Tumors, run by Assistance Publique Hopitaux De Marseille 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 2 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 6 Apr 2023. 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 accuracy of FDG-PETparticularly the SUVmax tumor/liver ratio, in the diagnosis of indeterminate adrenal tumors on conventional imaging. (time frame: 3 YEARS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01284829, which also lists 1 linked publication.
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 6 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.