Neoplasms

Gland and Hormone Related Diseases

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Adrenal Gland Neoplasms

Endocrine Gland Neoplasms

Adrenal Gland Diseases

Endocrine System Diseases

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Fluorodeoxyglucose F18

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Anesthetics, Intravenous

Anesthetics, General

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

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

FDG positron emission tomography

Iodometomidate imaging

Bruno Allolio, Professor

Hahner Stefanie, MD, PhD

Andreas Buck, Professor

Stefanie Hahner, MD, PhD

Stefanie Hahner, PD Dr.

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.

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.

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

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

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)

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.

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.

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

Wuerzburg University Hospital

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

Sorafenib

Patients will performed a TEP with 2 different radiotracer before treatment is started and 1 month after treatment has been started.

Subject will performed Positrons Emission tomography (PET) with 18F-Fluorocholine (FDG) before treatment with Sorafenib is started and 1 month after treatment started.

FDG Positron Emission Tomography

Subject will performed Positrons Emission tomography (PET) with 18F-Fluorocholine (FCH) before treatment with Sorafenib is started and 1 month after treatment started.

FCH Positron Emission Tomography

Pierre Fumoleau, Pr

Hepatocellular carcinoma (HCC) is the third cause of death by cancer. For patients with inoperable advanced HCC, systematic therapy with Sorafenib, a multikinase inhibitor that has both antiangiogenic and antiproliferative effect, is the only therapeutic with proven survival benefits. However, the efficacy of Sorafenib remains inconstant with a media overall survival of 10,7 months and a disease control rate only 35 to 43%; moreover, the overall incidence of treatment-related adverse event is 80%. Thus, it appears essential to find an early and accurate way to determine which patients are best responding to therapy in order to avoid the toxicity and cost of ineffective therapy.

Positron Emission Tomography (PET) with 18F-Fluorodeoxyglucose (FDG) has shown limited performance in the setting of HCC because of lack of sensitivity, in particular for well-differentiated tumours. However FDG uptake is related to proliferation rate and is an efficient marker survival following liver transplantation and selective internal radiation therapy. Moreover, the addition of a dynamic first-pass acquisition to the standard static scan provides better characterization of the tumour by adding information on tumour perfusion.

FCH which reflects lipids metabolism and specifically choline kinase activity, has shown promising results for detection of HCC when compared with FDG alone. Moreover, choline activity is related to a kinase pathway in mammalian cells, which is specifically inhibited by Sorafenib. However FCH uptake remains inconstant in HCC, and is related to tumour differentiation, by opposition to FDG. Therefore, several studies have suggested that combined evaluation of tumour glucose and lipid metabolism could play a complementary role for the evaluation of HCC in the setting of detection, staging and to predict recurrence following surgical resection. Thus, the investigator hypothesize that the combination of FDG and FCH may be the most accurate imaging evaluation of HCC.

Thus the aim of the present study is to determine the predictive performance of survival of lipid and glucose metabolism and perfusion changes during Sorafenib therapy in patients with advanced HCC.

Multimetabolic 18F-Fluorodeoxyglucose (FDG) and 18F-Fluorocholine (FCH) Positron Emission Tomography (PET) as an Early Predictive Factor of Overall Survival in Patients With Advanced Hepatocellular Carcinoma Treated With Sorafenib

Absence of radiologic progression according to modified RECIST criteria

Questionnaire will be completed by subject at each clinical surveillance visit

Centre Georges Francois Leclerc

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combined FDG-PET and 123I-Iodometomidate Imaging for Adrenal Neoplasia	NCT02010957	Adrenal Gland N...	FDG positron em... Iodometomidate ...	30 Years -	Wuerzburg University Hospital
Combined FDG-PET and 123I-Iodometomidate Imaging for Adrenal Neoplasia	NCT02010957	Adrenal Gland N...	FDG positron em... Iodometomidate ...	30 Years -	Wuerzburg University Hospital
Multimetabolic 18F-Fluorodeoxyglucose (FDG) and 18F-Fluorocholine (FCH) Positron Emission Tomography (PET) as an Early Predictive Factor of Overall Survival in Patients With Advanced Hepatocellular Carcinoma Treated With Sorafenib	NCT02847468	Carcinoma, Hepa...	FDG Positron Em... FCH Positron Em...	18 Years - 99 Years	Centre Georges Francois Leclerc

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