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

June 4, 2025 updated by: Wuerzburg University Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charité Universiaetsmedizin
      • Essen, Germany, 45147
        • Universitaetsklinikum Essen
      • Leipzig, Germany, 04103
        • Universitaetsklinik Leipzig
      • Mainz, Germany, 55131
        • Universitaetsmedizin Mainz
      • Muenchen, Germany, 80336
        • Klinikum der Universitaet Muenchen
      • Wuerzburg, Germany, 97080
        • University Hospital Wuerzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FDG positron emission tomography and Iodometomidate imaging
Combined FDG PET and Iodometomidate imaging prior adrenal surgery of uncertain adrenal neoplasms
Other: FDG positron emission tomography
2 consecutive imaging studies (diagnostic study) within 1-2 weeks: FDG-PET and 123I-Iodometomidate imaging in patients with an indeterminate adrenal neoplasm
Other Names:
  • FDG PET
Other: 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
Other Names:
  • IMTO imaging
  • 123I-Iodometomidate imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
within 1 to 2 weeks (minimum 2 days, maximum 6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity 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)
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.
within 1 to 2 weeks (minimum 2 days, maximum 6 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of safety of 123I-IMTO imaging
Time Frame: 2 to 4 weeks after IMTO imaging
Adverse events as well as standard routine parameter changes from before imaging to prior surgery will be assessed (plus follow up analysis until 30 days after surgery)
2 to 4 weeks after IMTO imaging

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuerzburg University Hospital

Collaborators

German Research Foundation
Steroid Metabolism Analysis Core, University of Birmingham
EU FP7 ENSAT Cancer

Investigators

  • Principal Investigator: Stefanie Hahner, Prof. Dr., University of Wuerzburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

December 4, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimated)

December 13, 2013

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAMIAN (KS8-341)
  • 2012-003604-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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