Clinical trial · Interventional
Combined FDG-PET and 123I-Iodometomidate Imaging for Adrenal Neoplasia
Combined 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) and Metomidate Imaging for Adrenal Neoplasia (FAMIAN-Study) - a Diagnostic Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Stop of tracer production by company, unavailability of 123I Iodometomidate at most study centers, slow recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenal Neoplasia | Adrenal Gland Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FDG positron emission tomography | Other | — | UNRESOLVED |
| Iodometomidate imaging | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FDG positron emission tomography and Iodometomidate imaging
- description
- Combined FDG PET and Iodometomidate imaging prior adrenal surgery of uncertain adrenal neoplasms
- interventionNames
- Other: FDG positron emission tomography
- Other: Iodometomidate imaging
Primary outcomes (1)
- measure
- Specificity of combined FDG-PET and 123I-IMTO imaging for diagnosing adrenocortical adenoma
- timeFrame
- within 1 to 2 weeks (minimum 2 days, maximum 6 weeks)
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria * 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 * Effective contraception in female patients of childbearing potential * Negative pregnancy test in women of childbearing potiential * Ability to comply with protocol procedures Exclusion Criteria * Pregnancy or breast feeding * Patient unfit or unwilling to undergo surgery / biopsy * Diagnosis of pheochromocytoma * Diagnosis of primary hyperaldosteronism * Diagnosis of Cushing´s syndrome
References
Publications (4)
- BACKGROUNDHahner 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. PMID 23426614
- BACKGROUNDHahner 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. PMID 18397978
- RESULThttps://doi.org/10.1016/j.ebiom.2025.105735
- DERIVEDHahner 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. PMID 40398350