18-F-Fluoroacetate as PET Imaging Agent

Breast Cancer Clinical Trial

Official title: A Phase I Study of 18-F-Fluoroacetate Sodium as a PET Imaging Agent for Tumor Detection

Status Withdrawn

Clinical Trial Summary

The goal of this clinical research study is to find out the highest tolerable dose of an imaging solution called 18-F-fluoroacetate sodium that can be given before a positron emission tomography (PET) scan. The safety of this solution will also be studied.

Clinical Trial Description

The Study Solution:

18-F-fluoroacetate sodium is designed to be attracted to cells that grow in some tumors. This imaging solution has a small dose of radiation added to it, which may help the doctor to "see" cancer cells and their possible spread through the body, during the scans. This is the first study using 18-F-fluoroacetate sodium in humans.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to an imaging study date. The first group of 6 participants will receive a smaller dose of solution (less than one half of the regular PET scan tracer radioactivity). The later 2 groups may receive the same dose of solution or a larger dose, but the larger dose will still be no more than what you would receive in a regular clinic PET scan procedure.

Study Solution Administration and PET Scans:

On Day 1, you will receive 18-F-fluoroacetate sodium by vein over 5 minutes.

You will then have 3 PET scans with a PET/CT scanner. You will be lying down during the PET scan. Each scanning period will take about 1 hour. You will have a 20-minute rest period between each scan.

Before each PET scan, you will have a CT scan, called a "Scout View", to check your position in the machine. This should take about 5 minutes.

You may continue receiving standard treatment from your regular doctor throughout the entire time you are in this study.

Study Visits:

On Day 1 (the day of the injection and imaging study):

• You will have an ECG, your vital signs will be measured, and the injection site will be checked at 5 minutes before, and 30 minutes and 2 ½ hours after the imaging solution is injected.

• You will be asked if you have had any side effects.

• Blood (about 2 tablespoons total) will be drawn 9 times over 2 ½ hours after the injection for pharmacokinetic (PK) testing. PK testing measures the amount of the imaging solution in the body at different time points.

• Urine will also be collected to test the amount of radiation that might have been absorbed by the body. This will be collected during the 10 minute rest periods.

On Day 2:

• Your vital signs will be measured.

• You will have an ECG.

• Blood (about 2-3 tablespoons) will be drawn for routine tests.

• The injection site will be checked.

• You will be asked if you have had any side effects.

On Day 7:

• You will have a physical exam, including measurement of your vital signs.

• You will have an ECG.

• Blood (about 2-3 tablespoons) will be drawn for routine tests.

• The injection site will be checked.

• You will be asked if you have had any side effects.

On about Day 30:

• You will have a physical exam, including measurement of your vital signs.

• You will have an ECG.

• Blood (about 2-3 tablespoons) will be drawn for routine tests.

• The injection site will be checked.

• You will be asked if you have had any side effects.

Length of Study:

You will be on active study for the day you receive the imaging and 18-F-fluoroacetate sodium. You will be on follow-up for up to 30 days after the imaging.

This is an investigational study. 18-F-fluoroacetate sodium is not FDA approved or commercially available. At this time, it is being used in research only. The study scans are also considered investigational when used for this purpose, and will not be used for planning your cancer treatment.

Up to 18 patients will take part in this study. All will be enrolled at M. D. Anderson. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Cancer
• Breast Cancer
• Prostate Cancer

• NCT number: NCT01320787
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Withdrawn
• Phase: Phase 1
• Start date: October 2014