NCT02010957

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2015

Longer than P75 for phase_3

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
1.5 years until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

5.5 years

First QC Date

December 4, 2013

Last Update Submit

June 4, 2025

Conditions

Adrenal Neoplasia

Keywords

123I Iodometomidate imaging18F FDG positron emission tomographyAdrenal tumourAdrenal neoplasia

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

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

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

Other Outcomes (1)

  • Assessment of safety of 123I-IMTO imaging

    2 to 4 weeks after IMTO imaging

Study Arms (1)

FDG positron emission tomography and Iodometomidate imaging

EXPERIMENTAL

Combined FDG PET and Iodometomidate imaging prior adrenal surgery of uncertain adrenal neoplasms

Other: FDG positron emission tomographyOther: Iodometomidate imaging

Interventions

FDG positron emission tomographyOTHER

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

Also known as: FDG PET
FDG positron emission tomography and Iodometomidate imaging
Iodometomidate imagingOTHER

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

Also known as: IMTO imaging, 123I-Iodometomidate imaging
FDG positron emission tomography and Iodometomidate imaging

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Charité Universiaetsmedizin

Berlin, 13353, Germany

Location

Universitaetsklinikum Essen

Essen, 45147, Germany

Location

Universitaetsklinik Leipzig

Leipzig, 04103, Germany

Location

Universitaetsmedizin Mainz

Mainz, 55131, Germany

Location

Klinikum der Universitaet Muenchen

München, 80336, Germany

Location

University Hospital Wuerzburg

Würzburg, 97080, Germany

Location

Related Publications (4)

  • 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.

    PMID: 23426614BACKGROUND

  • 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.

    PMID: 18397978BACKGROUND

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

    RESULT

  • 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.

    PMID: 40398350DERIVED

MeSH Terms

Conditions

Adrenal Gland Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsAdrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • Stefanie Hahner, Prof. Dr.

    University of Wuerzburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 13, 2013

Study Start

July 1, 2015

Primary Completion

January 1, 2021

Study Completion

July 1, 2022

Last Updated

June 10, 2025

Record last verified: 2025-06

Locations

DE(6)