Clinical Trial · NCT03883776

Al18F-NOTA-octreotide PET Imaging of the Somatostatin Receptor in Neuroendocrine Tumors

Overview

The aim of this study is to evaluate the potential of Al18F-1,4,7-triazacyclononane-1,4,7-triacetate-octreotide (Al18F-NOTA-octreotide) as a positron emission tomography (PET) somatostatin receptor imaging agent in patients with neuroendocrine tumors.

Sponsor

Unknown Organization

Phase

Phase 1

Contacts

Christophe Deroose, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03883776

Drug / Compound

NOTA-octreotide

Isotope(s):

Target(s):

SSTR2

Ligand Class: Peptides

Chelator: NOTA

Eligibility

Inclusion

Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs and clinical laboratory tests
Subject is diagnosed with a neuroendocrine tumor of gastroenteropancreatic, pulmonary, neural crest or unknown primary origin
Part 1: Healthy volunteers:
Female subjects should be post-menopausal or surgically sterile or using effective contraceptive with negative pregnancy test
Female subjects should be post-menopausal or surgically sterile or using effective contraceptive with negative urinary pregnancy testPart 2: Neuroendocrine tumor patients:
Subject should have at least 5 positive lesions on routine clinical 68Ga-DOTA-peptide PET performed within 6 months prior to the inclusion visit. A positive lesion is defined as tracer uptake above background deemed to be caused by the presence of NET cells by an experienced nuclear medicine physician
Subject is judged to be in good general condition by the investigator on the basis of medical history, physical examination including vital signs and clinical laboratory tests, besides the diagnosis of neuroendocrine tumor.

Exclusion

Subject has a history of multiple and/or severe allergies to drugs or food
Subject is currently a user (including ''recreational use'') of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse
Subject underwent surgery between the selection and inclusion visit
Subject takes concomitant medication, except for oral contraceptives, sporadic paracetamol, or low-dose and limited in time non-steroidal antiinflammatory drugs
Subject suffers from claustrophobia or cannot tolerate confinement during PET/CT scanning procedures; subject cannot lie still for 60 minutes inside the scanner
Subject has a previous or ongoing recurrent or chronic disease, other than a neuroendocrine tumor, at high risk to interfere with the evaluation of the trial according to the judgement of the investigator, e.g. known gastro-intestinal, hepatic, renal, cardiovascular, metabolic or hormonal disease, cancer, major neurological or convulsive disorder or any psychiatric disease
Subject has recently (\< 30 days) participated or is simultaneously participating in another prospective interventional clinical trial
Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e. weight lifting, running, bicycling) from the time of the selection visit until the safety visit
Part 1: Healthy volunteers:
Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator
Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator
Subject is unable to refrain from smoking more than 10 cigarettes per day during the study
Subject is mentally or legally incapacitatedPart 2: Neuroendocrine tumor patients:
Subject has had exposure to ionizing radiation (\> 1 mSv) in other research studies within the last 12 months
Subject does not understand the study procedure
Subject does not understand the study procedure
Subject is unable to refrain from smoking more than 10 cigarettes per day during the study
Subject has a previous or ongoing recurrent or chronic disease able to interfere with the evaluation of the trial according to the judgement of the investigator, especially a known gastro-intestinal, hepatic, renal, cardiovascular, metabolic or hormonal disease, cancer, major neurological or convulsive disorder or any psychiatric disease
Subject is potentially pregnant (urinary hCG test will be performed in women where pregnancy is not excluded), wishes to become pregnant up to 3 months after administration of Al18F-NOTA-octreotide or is breast-feeding
Subject has had exposure to ionizing radiation (\> 1 mSv) in other research studies within the last 12 months
Subject is potentially pregnant (urinary hCG test will be performed in women where pregnancy is not excluded), wishes to become pregnant up to 3 months after administration of Al18F-NOTA-octreotide or is breast-feeding
Subject has a history of multiple and/or severe allergies to drugs or food
Subject is currently a user (including ''recreational use'') of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse
Subject has recently (\< 30 days) participated or is simultaneously participating in another prospective interventional clinical trial
Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e. weight lifting, running, bicycling) from the time of the selection visit until the telephone follow-up interview.
Subject suffers from claustrophobia or cannot tolerate confinement during PET/CT scanning procedures; subject cannot lie still for 90 minutes inside the scanner
Subject underwent surgery between the selection and inclusion visit
Subject is mentally or legally incapacitated