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

Adrenal Gland Neoplasms Clinical Trial

— FAMIAN  

Official title:

Combined 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) and 123I-Iodometomidate (123I-IMTO) Imaging for Adrenal Neoplasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02010957
• Other study ID #: KS8-341
• Secondary ID: 2012-003604-13
• Status: Recruiting
• Phase: Phase 3
• First received: December 4, 2013
• Last updated: April 9, 2018
• Start date: August 2015
• Est. completion date: June 2020

Study information

• Verified date: April 2018
• Source: Wuerzburg University Hospital
• Contact: Bruno Allolio, Professor
• Phone: +49931201-0
• Email: allolio_b[@]ukw.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Patients with a solid indeterminate adrenal mass scheduled for surgery with a diameter > 3 cm or an increase in tumour diameter after the initial evaluation of > 1 cm during follow-up, age =30 years

Exclusion Criteria:

• Patient unfit or unwilling to undergo surgery, biochemical evidence of phaeochromocytoma, primary hyperaldosteronism or overt clinical Cushing's syndrome

Related Conditions & MeSH terms

• Adrenal Gland Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	University Hospital Wuerzburg	Wuerzburg

Sponsors (15)

Lead Sponsor

Collaborator

Wuerzburg University Hospital

Assistance Publique - Hôpitaux de Paris, Cambridge University Hospitals NHS Foundation Trust, Charite University, Berlin, Germany, Hannover Medical School, Heinrich-Heine University, Duesseldorf, Johannes Gutenberg University Mainz, Ludwig-Maximilians - University of Munich, University Hospital, Essen, University Medical Center Nijmegen, University of Florence, University of Leipzig, University of Padova, University of Vienna, Uppsala University Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of safety of 123I-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
Primary	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	Sensitivity of combined FDG-PET and 123I-IMTO imaging for diagnosing adrenocortical adenoma	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)