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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2022-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Adrenal Neoplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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FDG positron emission tomography and Iodometomidate imaging

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

Group Type EXPERIMENTAL

FDG positron emission tomography

Intervention Type OTHER

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

Iodometomidate imaging

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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FDG PET IMTO imaging 123I-Iodometomidate imaging

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No