Trial record 5 of 27 for:    Open Studies | "Adrenal Gland Neoplasms"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Wuerzburg University Hospital
Sponsor:
Collaborators:
Charite University, Berlin, Germany
Heinrich-Heine University, Duesseldorf
University Hospital, Essen
Johannes Gutenberg University Mainz
Ludwig-Maximilians - University of Munich
Hannover Medical School
University of Leipzig
University of Florence
University of Padova
Cambridge University Hospitals NHS Foundation Trust
University Medical Center Nijmegen
Uppsala University Hospital
Assistance Publique - Hôpitaux de Paris
University of Vienna
Information provided by (Responsible Party):
Wuerzburg University Hospital
ClinicalTrials.gov Identifier:
NCT02010957
First received: December 4, 2013
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Adrenal Gland Neoplasms
Other: FDG positron emission tomography
Other: Iodometomidate imaging
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Combined 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) and 123I-Iodometomidate (123I-IMTO) Imaging for Adrenal Neoplasia

Resource links provided by NLM:


Further study details as provided by Wuerzburg University Hospital:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Assessment of safety of 123I-IMTO imaging [ Time Frame: 2 to 4 weeks after IMTO imaging ] [ Designated as safety issue: Yes ]
    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)


Estimated Enrollment: 220
Study Start Date: June 2014
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02010957

Contacts
Contact: Bruno Allolio, Professor +49931201-0 ext 39020 allolio_b@ukw.de

Locations
Germany
University Hospital Wuerzburg Not yet recruiting
Wuerzburg, Germany, 97080
Contact: Bruno Allolio, Professor    +49931201-0 ext 39020    allolio_b@ukw.de   
Contact: Andreas Buck, Professor    +49931201-0 ext 35001    buck_a@ukw.de   
Sponsors and Collaborators
Wuerzburg University Hospital
Charite University, Berlin, Germany
Heinrich-Heine University, Duesseldorf
University Hospital, Essen
Johannes Gutenberg University Mainz
Ludwig-Maximilians - University of Munich
Hannover Medical School
University of Leipzig
University of Florence
University of Padova
Cambridge University Hospitals NHS Foundation Trust
University Medical Center Nijmegen
Uppsala University Hospital
Assistance Publique - Hôpitaux de Paris
University of Vienna
Investigators
Principal Investigator: Stefanie Hahner, PD Dr. University of Wuerzburg
  More Information

Publications:
Responsible Party: Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT02010957     History of Changes
Other Study ID Numbers: KS8-341, 2012-003604-13
Study First Received: December 4, 2013
Last Updated: December 10, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Wuerzburg University Hospital:
123I Iodometomidate imaging
18F FDG positron emission tomography
Adrenal tumour

Additional relevant MeSH terms:
Adrenal Gland Neoplasms
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Gland Diseases
Endocrine System Diseases
Epinephrine
Epinephryl borate
Etomidate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 10, 2014