Positron Emission Tomography (PET) Imaging Studies With NIS Reporter

Endometrial Cancer Clinical Trial

Official title:

First In-human PET Imaging Studies With NIS Reporter [18F]BF4

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02907073
• Other study ID #: 15-002494
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: September 2016
• Est. completion date: December 2017

Study information

• Verified date: May 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

F-18 tetrafluoroborate (BF4) or (TFB) is being used as a PET (Positron Emission Tomography) imaging biomarker for expression of the human sodium/iodide symporter (hNIS) in tissues. Imaging of functional hNIS activity in tissues with [18F]BF4 is anticipated to provide superior sensitivity and image quality to I-123 or Tc-99m SPECT for monitoring hNIS transduction effected by viral therapies. The proposed work is designed to 1) evaluate its safety, biodistribution, metabolism and radiation dosimetry characteristics in 8 healthy human volunteers and 2) evaluate the imaging feasibility in comparison with I-123 or Tc-99m SPECT of hNIS expression in a) 10 myeloma patients treated with Edmonston Measles virus-NIS (MV-NIS) and b) 10 endometrial cancer patients treated with vesicular stomatitis virus engineered to express human interferon and NIS (VSV-hINF-NIS). This data will be necessary to support future regulatory submissions.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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:

1. cardiac surgery or myocardial infarction within the last 6 months;

2. unstable angina;

3. coronary artery disease that required a change in medication within the last 3 months;

4. decompensated congestive heart failure;

5. 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;

6. severe mitral or aortic valvular disease;

7. uncontrolled high blood pressure;

8. 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 (ß-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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Myeloma

Intervention

Drug:
• BF4
Single IV dose of 9-11 millicurie (mCi) sodium [Fluorine-18] radiolabeled B4^F

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers	F-18 BF4 concentrations in major tissues (e.g., heart, blood pool, lung, liver, thyroid, stomach, kidney, brain, muscle) will be evaluated from the PET images from 0-240 minutes post-administration. Results will be used to compute radiation dosimetry estimates.	0-240 minutes
Secondary	Amount of Imaging Agent in Tumor (Uptake) in Myeloma and Endometrial Cancer Patients	Areas of positive uptake within tumor, relative to background, measured by Standardized Update Value (SUV). PET SUV is tissue concentration/injected dose/body weight in grams.	Baseline, Day 9

External Links

•   Mayo Clinic Clinical Trials