A Phase 1 interventional study of 18F-fluoroacetate in Brain Cancer, Breast Cancer and Prostate Cancer, sponsored by M.D. Anderson Cancer Center. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-23.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Diagnostic
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.
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):
On Day 2:
On Day 7:
On about Day 30:
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.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
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Exclusion Criteria:
18F-fluoroacetate injection as a single intravenous bolus with a maximum volume of 4 mL followed by a saline flush of 20 to 50 mL.
Drug: 18F-fluoroacetate
18F-fluoroacetate injection as a single intravenous bolus with a maximum volume of 4 mL followed by a saline flush of 20 to 50 mL.
Biodistribution of 18F-Fluoroacetate
Biodistribution of 18F-fluoroacetate is measured during imaging, using a radioisotope (18F) of fluoroacetate PET scan. The percent injected dose (%ID) obtained in different organs derived from the PET data.
Time frame: 1 day
No study locations are listed for this record.
This study is withdrawn, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center