Clinical trial NCT02010957: Combined FDG-PET and 123I-Iodometomidate Imaging for Adrenal Neoplasia
Official title: ￼Combined 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) and Metomidate Imaging for Adrenal Neoplasia (FAMIAN-Study) - a Diagnostic Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Adrenal Neoplasia
Keywords: 123I Iodometomidate imaging
18F FDG positron emission tomography
Adrenal tumour
Adrenal neoplasia
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: Steroid Metabolism Analysis Core, University of Birmingham
name: EU FP7 ENSAT Cancer
First posted: 2013-12-13
Enrollment: 85
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 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.

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.

Eligibility criteria: 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

Primary outcomes:
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)
Secondary outcomes:
measure: Sensitivity of combined FDG-PET and 123I-IMTO imaging for diagnosing adrenocortical adenoma
timeFrame: within 1 to 2 weeks (minimum 2 days, maximum 6 weeks)
Other outcomes:
measure: Assessment of safety of 123I-IMTO imaging
timeFrame: 2 to 4 weeks after IMTO imaging
Locations:
city: Berlin
country: Germany
facility: Charité Universiaetsmedizin
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Leipzig
country: Germany
facility: Universitaetsklinik Leipzig
city: Mainz
country: Germany
facility: Universitaetsmedizin Mainz
city: Muenchen
country: Germany
facility: Klinikum der Universitaet Muenchen
city: Wuerzburg
country: Germany
facility: University Hospital Wuerzburg
Study officials:
affiliation: University of Wuerzburg
name: Stefanie Hahner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: https://doi.org/10.1016/j.ebiom.2025.105735