Positron Emission Tomography (PET) Imaging Studies With NIS Reporter

Stopped early · Phase 1/Phase 2

Conditions studied: Myeloma, Endometrial Cancer

In brief

The goal of this proposal is to perform first-in-man evaluation of and experimental imaging agent F-18 tetrafluoroborate (BF4) or (TFB).

Key facts

Study ID

NCT02907073

Run by

Mayo Clinic

People needed

8

Starts

2016-09-01

Expected to finish

2017-12-01

Last updated by the study team

2019-05-17

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Four male and four female healthy volunteers, greater than 21 years of age.
• Subjects must provide written informed consent.
• Willingness to provide all biological specimens as required by the protocol

You may not qualify if…

• Volunteers with any of the following are ineligible to enroll in this study:
• Have currently clinically significant cancer, neurologic, hepatic, renal, pulmonary, metabolic, or endocrine disturbances, especially thyroid disease;
• Current clinically significant cardiovascular disease. Clinically significant cardiovascular disease usually includes one or more of the following:
• cardiac surgery or myocardial infarction within the last 6 months;
• unstable angina;
• coronary artery disease that required a change in medication within the last 3 months;
• decompensated congestive heart failure;
• significant cardiac arrhythmia or conduction disturbance, particularly those resulting in atrial or ventricular fibrillation, or causing syncope, near syncope, or other alterations in mental status;
• severe mitral or aortic valvular disease;
• uncontrolled high blood pressure;
• congenital heart disease;
• History of drug or alcohol abuse within the last year, or prior prolonged history of abuse;
• Clinically significant infectious disease, including AIDS or HIV infection or previous positive test for hepatitis B, hepatitis C, HIV-1, or HIV-2;
• Women of childbearing potential must not be pregnant (negative urine Human Chorionic Gonadotropin (β-HCG) at the time of screen) or lactating over the course of the study. A commercial urine dipstick test will be performed within 48 hours prior to injection of [18F]BF4 unless the screening urine pregnancy test falls within 48 hours of injection.
• Volunteers who, in the opinion of the investigator, are otherwise unsuitable for a study of this type;
• History of severe drug allergy or hypersensitivity; or
• Volunteers who had received an investigational medication within the last 30 days or who have participated in a clinical trial with any experimental medication or radiopharmaceutical in the last 30 days. Additionally, the time between the last dose of the previous experimental medication and enrollment (completion of screening assessments) must be at least equal to 5 times the terminal half-life of the previous experimental medication.
• Volunteers who are taking drugs with narrow therapeutic windows, such as theophylline, or warfarin, heparin and other anticoagulant therapies

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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