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

NCT02010957 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2025-06-10

No results posted yet for this study

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.

Conditions

  • Adrenal Neoplasia

Interventions

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

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

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • Steroid Metabolism Analysis Core, University of Birmingham

    collaborator UNKNOWN

  • EU FP7 ENSAT Cancer

    collaborator UNKNOWN

  • Wuerzburg University Hospital

    lead OTHER

Principal Investigators

  • Stefanie Hahner, Prof. Dr. · University of Wuerzburg

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2021-01-31
Completion
2022-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02010957 on ClinicalTrials.gov