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WithdrawnNCT01320787Updated Oct 23, 2014

18-F-Fluoroacetate as PET Imaging Agent

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 Withdrawn.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

Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Brain Cancer
  • Breast Cancer
  • Prostate Cancer

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Keywords

  • 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
03

In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

Browse Brain Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 \</= 1.5 x upper limit of normal e) Bilirubin \</= 2 x upper limit of normal (exceptions will be made for patients with Gilbert's Disease). f) SGOT (AST) \</= 2.5 x upper limit of normal. g) SGPT (ALT) \</= 2.5 x 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

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 protocol.
  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 media.
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    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.

    Drug: 18F-fluoroacetate

Interventions

  • Drug18F-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.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01320787
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Mar 22, 2011
Start date
Oct 2014
Primary completion
Oct 2016 (estimated)
Last update
Oct 23, 2014

Study contacts

Donald Podoloff, MD, BA
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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