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Adrenal NeoplasiaPhase 3FAMIANNCT02010957

Combined FDG-PET and 123I-Iodometomidate Imaging for Adrenal Neoplasia

A Phase 3 study testing FDG positron emission tomography and Iodometomidate imaging in people with Adrenal Neoplasia, run by Wuerzburg University Hospital at 6 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Adrenal masses are highly prevalent and detected with high frequency by conventional imaging. Conventional imaging often fails to rule out a malignant lesion. Accordingly, most hormonally inactive adrenal masses removed by surgery are benign adenomas for which surgical removal is unnecessary and poses an avoidable… Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Adrenal Neoplasia
What is being tested?
FDG positron emission tomography and Iodometomidate imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
6 sitesGermany
Study dates
Jul 2015to Jul 2022
Phase
Phase 3
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 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged >= 30 years
  • with a solid indeterminate adrenal mass with a diameter > 3 cm or an increase in tumor diameter of > 1 cm after the initial evaluation
  • with an attenuation value of the adrenal tumor >= 10 Hounsfield units (HU) in unenhanced computerized tomography (CT)
  • scheduled for surgery or biopsy within 3 months
  • Written informed consent
  • ECOG performance status 0-2
Show all 9Show fewer
  • Effective contraception in female patients of childbearing potential
  • Negative pregnancy test in women of childbearing potiential
  • Ability to comply with protocol procedures

Who cannot join

  • Pregnancy or breast feeding
  • Patient unfit or unwilling to undergo surgery / biopsy
  • Diagnosis of pheochromocytoma
  • Diagnosis of primary hyperaldosteronism
  • Diagnosis of Cushing´s syndrome

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Charité Universiaetsmedizin

    Berlin, 13353

  • Universitaetsklinikum Essen

    Essen, 45147

  • Universitaetsklinik Leipzig

    Leipzig, 04103

  • Universitaetsmedizin Mainz

    Mainz, 55131

  • Klinikum der Universitaet Muenchen

    München, 80336

  • University Hospital Wuerzburg

    Würzburg, 97080

Other trials in Germany

About this study

Official title: Combined 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) and Metomidate Imaging for Adrenal Neoplasia (FAMIAN-Study) - a Diagnostic Study

Adrenal masses are highly prevalent and detected with high frequency by conventional imaging. Conventional imaging often fails to rule out a malignant lesion. Accordingly, most hormonally inactive adrenal masses removed by surgery are benign adenomas for which surgical removal is unnecessary and poses an avoidable risk to the patients. We hypothesize that the combination of FDG-PET and 123I-Iodometomidate imaging has the potential to noninvasively identify benign adrenocortical adenomas with high accuracy, thereby avoiding unnecessary surgery. Uptake of 123I-Iodometomidate by the adrenal mass demonstrates the presence of CYP 11B enzymes which specifically bind metomidate with high avidity establishing the adrenocortical origin of the lesion, while low uptake of FDG-PET in an adrenocortical lesion establishes its benign nature and excludes the presence of adrenocortical cancer (ACC). The proposed trial will assess the sensitivity, specificity, positive and negative predictive value of the combined imaging for the diagnosis of adrenocortical adenoma. A secondary focus is on the performance of the combined test for differentiating ACC from non-ACC lesions. We expect that the results of our trial will help to greatly reduce the need for surgery in hormonally inactive adrenal masses.

Read the detailed description

Histopathology of a surgically removed adrenal mass by an expert surgeon is considered to be the gold standard for the differential diagnosis of an adrenal neoplasia. Thus we will only recruit patients scheduled for surgery for an adrenal mass of uncertain origin. Patients will be eligible for the trial when an adrenal mass has been discovered and standard imaging (CT and/or MRI) has not led to a clear characterization of the malignant potential of the lesion (Hounsfield units in unenhanced CT ≥10). In addition, patients with adrenal neoplasia will be only recruited when a hormonally active lesion has been excluded and surgery is planned because of a perceived risk of malignancy. Patients will be evaluated by both [123I]Iodometomidate SPECT/CT and [18F]fluorodeoxyglucose PET/CT. Computed tomography will be performed as low dose CT of the adrenal region. Imaging can be started with either [123I]Iodometomidate SPECT/CT or [18F]fluoro- deoxyglucose PET/CT and can be performed at two consecutive days. The time interval between [123I]Iodometomidate SPECT/CT and [18F]fluorodeoxyglucose PET/CT should not exceed 6 weeks. Patients will have a follow up visit 2-4 weeks after [123I]Iodometomidate SPECT/CT and [18F]fluorodeoxyglucose PET/CT (or immediately before surgery, if earlier than 2 weeks post imaging). Thirty days after surgery patients will be contacted by phone for assessment of adverse events related to surgery.

Being tested
FDG positron emission tomography, Iodometomidate imaging
Keywords
123I Iodometomidate imaging, 18F FDG positron emission tomography, Adrenal tumour, Adrenal neoplasia
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 positron emission tomographyOther

    Also called FDG PET

    2 consecutive imaging studies (diagnostic study) within 1-2 weeks: FDG-PET and 123I-Iodometomidate imaging in patients with an indeterminate adrenal neoplasm

  • Iodometomidate imagingOther

    Also called IMTO imaging, 123I-Iodometomidate imaging

    2 consecutive imaging studies (diagnostic study) within 1-2 weeks: FDG-PET and 123I-Iodometomidate imaging in patients with an indeterminate adrenal neoplasm

Study groups in NCT02010957
Study groupRoleWhat they receive
FDG positron emission tomography and Iodometomidate imagingExperimentalCombined FDG PET and Iodometomidate imaging prior adrenal surgery of uncertain adrenal neoplasms
Receives: Other: FDG positron emission tomography; Other: Iodometomidate imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Specificity of combined FDG-PET and 123I-IMTO imaging for diagnosing adrenocortical adenoma

    Diagnostic study with combined FDG-PET and 123I-IMTO imaging in which an indeterminate adrenal mass with negative FDG-PET test (FDG-) and positive 123I-IMTO test (IMTO+) is diagnosed as a benign adrenocortical adenoma (AA+). Primary efficacy endpoint: Specificity (rate estimation) of the diagnostic AA test and likelihood ratio of a positive diagnostic test (using rate estimation of the sensitivity). The outcome measure does not assess a change but the diagnostic accuracy of both FDG-PET and IMTO imaging.

    Measured: within 1 to 2 weeks (minimum 2 days, maximum 6 weeks)

Secondary outcomes (1)

  1. Sensitivity of combined FDG-PET and 123I-IMTO imaging for diagnosing adrenocortical adenoma

    Sensitivity of the diagnostic adrenocortical adenoma (AA) test and likelihood ratio of a negative diagnostic AA test, a priori rates of AA, adrenocortical cancer (ACC) and other benign as well as malignant indeterminate adrenal neoplasias. Detection rates similar to sensitivity and specificity for ACC and indeterminate adrenal neoplasias other than AA and ACC of combined 18F-FDG-PET imaging and 123I-Iodometomidate imaging in identifying ACC. Predictive values will be determined and economic analysis of cost effectiveness of diagnostic evaluation versus surgery for all indeterminate lesions will be performed. The outcome measure does not assess a change but the diagnostic accuracy of both FDG-PET and IMTO imaging.

    Measured: within 1 to 2 weeks (minimum 2 days, maximum 6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2013 (estimated)
  2. Study startJul 2015
  3. Primary completionJan 2021
  4. Study completionJul 2022

Why it stopped: Stop of tracer production by company, unavailability of 123I Iodometomidate at most study centers, slow recruitment

Resources

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 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02010957
Sponsor's protocol ID
FAMIAN (KS8-341)
Other IDs
2012-003604-13
Acronym
FAMIAN
Status last verified
Jun 2025
First submitted
4 Dec 2013
Last updated
10 Jun 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Hahner S, Kreissl MC, Fassnacht M, Haenscheid H, Bock S, Verburg FA, Knoedler P, Lang K, Reiners C, Buck AK, Allolio B, Schirbel A. Functional characterization of adrenal lesions using [123I]IMTO-SPECT/CT. J Clin Endocrinol Metab. 2013 Apr;98(4):1508-18. doi: 10.1210/jc.2012-3045. Epub 2013 Feb 20.

    PubMed 23426614

  • Hahner S, Stuermer A, Kreissl M, Reiners C, Fassnacht M, Haenscheid H, Beuschlein F, Zink M, Lang K, Allolio B, Schirbel A. [123 I]Iodometomidate for molecular imaging of adrenocortical cytochrome P450 family 11B enzymes. J Clin Endocrinol Metab. 2008 Jun;93(6):2358-65. doi: 10.1210/jc.2008-0050. Epub 2008 Apr 8.

    PubMed 18397978

  • https://doi.org/10.1016/j.ebiom.2025.105735

  • Hahner S, Hartrampf P, Beuschlein F, Miederer M, Miehle K, Schlotelburg W, Fuss CT, Pfluger T, Fottner C, Tonjes A, Herrmann K, Amthauer H, Reincke M, Schreckenberger M, Sabri O, Werner J, Reuter M, Kircher S, Arlt W, Fassnacht M, Konrad Buck A, Muller HH, Schirbel A; FAMIAN investigators. Combined [18F]Fluorodeoxyglucose PET and [123I]Iodometomidate-SPECT for diagnostic evaluation of indeterminate adrenal neoplasias-the cross-sectional diagnostic test accuracy study FAMIAN. EBioMedicine. 2025 Jun;116:105735. doi: 10.1016/j.ebiom.2025.105735. Epub 2025 May 20.

    PubMed 40398350

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FDG positron emission tomography and Iodometomidate imaging in people with Adrenal Neoplasia, run by Wuerzburg University Hospital at 6 sites in Germany.

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 9 inclusion and 5 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: stopped early, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Stop of tracer production by company, unavailability of 123I Iodometomidate at most study centers, slow recruitment). Results are not available in the source record.

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?

Specificity of combined FDG-PET and 123I-IMTO imaging for diagnosing adrenocortical adenoma (time frame: within 1 to 2 weeks (minimum 2 days, maximum 6 weeks)). 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 NCT02010957, which also lists 4 linked publications.

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 10 Jun 2025.

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