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

Phase 1
18 Years
Not Enrolling
Brain Cancer, Breast Cancer, Prostate Cancer

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Trial Information

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

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

- 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.

Inclusion Criteria:

1. Patients must have: a) Histologic or cytologic confirmation of adenocarcinoma of the
prostate; or b) A histologically confirmed, treatment-naïve, locally advanced breast
cancer that express either estrogen receptor (ER) or progesterone receptor (PR) and
are negative for ErbB2 by Immunohistochemistry (IHC) and/or fluorescence in situ
hybridization (FISH) gene amplification; or c) Suspected supratentorial malignant
primary or secondary malignant tumor of the central nervous system (CNS).

2. The Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2 or Karnofsky
Performance Status of ≥ 60.

3. Four weeks or greater since major surgery.

4. Required Initial Laboratory Data: a) White Blood Count (WBC) >/= 3,000/microliters.
b) Absolute neutrophil count (ANC) >/= 1,500/microliters. c) Platelet count >/=
100,000/microliters. d) Creatinine x upper limit of normal (exceptions will be made for patients with Gilbert's
Disease). f) SGOT (AST) upper limit of normal.

5. Subjects must be at least 18 years of age

6. All sexually active subjects of child-bearing potential (CBP) must agree to use
adequate contraception (hormonal or barrier method of birth control) for the duration
of study participation from signing of consent till 30 days post injection. Should a
male patient's sexual partner become pregnant or suspects that she is pregnant while
the patient is participating in the study, the treating physician should be notified
immediately. Female subjects of CBP must have a negative serum pregnancy test within
24 hours prior to the administration of the protocol imaging agent.

7. For patients with adenocarcinoma of the prostate, they must have radiographic
evidence of metastatic prostate cancer; measurable lymph node disease on either CT
scan, MRI with any level of serum PSA. (There is no limitation of the type or numbers
of prior chemotherapy regimens, palliative radiotherapy or other non-chemotherapy or
hormonal therapies for metastatic disease.)

8. For subjects with breast cancer, they must have local disease evaluated by standard
breast imaging before initiation of treatment and no evidence of metastatic disease.

9. For subjects with a recent biopsy of newly diagnosed high-grade tumor, they must have
recovered from the effects of surgical biopsy. It must be at least >/= 7 days after a
brain biopsy to be eligible.

10. Patients must have signed an informed consent document stating that they understand
the investigational nature of the proposed imaging agent.

11. Baseline imaging of all tumor types must be within 21 days of protocol PET imaging
day, but more than 24 hours prior to the protocol PET imaging tracer administration.
Patients can receive other standard diagnostic imaging procedures 24 hours post
protocol PET imaging day.

Exclusion Criteria:

1. Patients with significant cardiovascular disease including congestive heart failure
(New York Heart Association Class III or IV), active angina pectoris or recent
myocardial infarction (within the last 6 months) are excluded.

2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

3. History of allergic reactions attributed to compounds of similar chemical or biologic
composition (i.e. 18F-FDG)

4. Patients may not be receiving any other investigational agents while on this

5. Patients with prostate cancer may not be receiving dutasteride or finasteride up to 2
weeks prior to enrollment.

6. Patients who have received prior cytotoxic, biologic, hormonal (other than for
replacement) therapy to treat the breast cancer. (Patients may continue on a daily
Multi-Vitamin and any other herbal, alternative or food supplements.)

7. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious disease) illness must
not be enrolled into the study.

8. Patients with metastatic adenocarcinoma of the prostate documented by bone scan
alone, are ineligible.

9. Sexually active fertile men not using effective birth control if their partners are
women of childbearing potential (WOCBP).

10. Women who are pregnant, not using effective birth control or lactating are ineligible

11. The subject is unable to lie down for 150 minutes.

12. The subject suffers from claustrophobia.

13. The subject has a history of serious hypersensitivity reaction to iodinated contrast

Type of Study:


Study Design:

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

Outcome Measure:

Biodistribution of 18F-Fluoroacetate

Outcome Description:

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.

Outcome Time Frame:

1 day

Safety Issue:


Principal Investigator

Donald Podoloff, MD, BA

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2013

Completion Date:

Related Keywords:

  • Brain Cancer
  • Breast Cancer
  • Prostate Cancer
  • Brain
  • Adenocarcinoma of the prostate
  • Locally advanced breast cancer
  • Estrogen receptor
  • ER
  • Progesterone receptor
  • PR
  • Negative for ErbB2
  • Malignant tumor of the central nervous system
  • CNS
  • Brain Neoplasms
  • Breast Neoplasms
  • Prostatic Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030