Brain CancerPhase 1NCT01320787
18-F-Fluoroacetate as PET Imaging Agent
A Phase 1 study testing 18F-fluoroacetate in people with Brain Cancer and Breast Cancer, run by M.D. Anderson Cancer Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer, Breast Cancer, Prostate Cancer
- What is being tested?
- 18F-fluoroacetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Oct 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- The Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2 or Karnofsky Performance Status of ≥ 60.
- Four weeks or greater since major surgery.
- 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.
- Subjects must be at least 18 years of age
- 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.
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- 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.)
- 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.
- 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.
- Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed imaging agent.
- 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.
Who cannot join
- 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.
- 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.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition (i.e. 18F-FDG)
- Patients may not be receiving any other investigational agents while on this protocol.
- Patients with prostate cancer may not be receiving dutasteride or finasteride up to 2 weeks prior to enrollment.
- 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.)
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- 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.
- Patients with metastatic adenocarcinoma of the prostate documented by bone scan alone, are ineligible.
- Sexually active fertile men not using effective birth control if their partners are women of childbearing potential (WOCBP).
- Women who are pregnant, not using effective birth control or lactating are ineligible
- The subject is unable to lie down for 150 minutes.
- The subject suffers from claustrophobia.
- The subject has a history of serious hypersensitivity reaction to iodinated contrast media.
About this study
Official title: A Phase I Study of 18-F-Fluoroacetate Sodium as a PET Imaging Agent for Tumor Detection
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.
- Conditions
- Brain Cancer, Breast Cancer, Prostate Cancer
- Being tested
- 18F-fluoroacetate
- 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
- Medical subject headings
- Brain Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluoroacetateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 18F-fluoroacetate | Experimental | 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. Receives: Drug: 18F-fluoroacetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donald Podoloff, MD, BA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320787
- Sponsor's protocol ID
- 2009-0157
- Other IDs
- NCI-2011-01066
- Status last verified
- Oct 2014
- First submitted
- 21 Mar 2011
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of 18-F-Fluoroacetate Sodium as a PET Imaging Agent for Tumor Detection
- ClinicalTrials.gov ID
- NCT01320787
- Acronym / sponsor ID
- 2009-0157
- Conditions
- Brain Cancer, Breast Cancer, Prostate Cancer
- Keywords
- Brain, Adenocarcinoma of the prostate, Locally advanced breast cancer, Estrogen receptor, ER, Progesterone receptor, PR, Negative for ErbB2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- First posted
- 22 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-fluoroacetate | Experimental | Drug: 18F-fluoroacetate18F-fluoroacetate injection as a single intravenous bolus with a maximum volume of 4 mL followed by a saline flush of 20 to 50 mL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
- The Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2 or Karnofsky Performance Status of ≥ 60.
- Four weeks or greater since major surgery.
- 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.
- Subjects must be at least 18 years of age
Key exclusion criteria (13 listed)
- 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.
- 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.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition (i.e. 18F-FDG)
- Patients may not be receiving any other investigational agents while on this protocol.
- Patients with prostate cancer may not be receiving dutasteride or finasteride up to 2 weeks prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-fluoroacetate18F-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 |
Primary outcome
Biodistribution of 18F-Fluoroacetate
Time frame: 1 day
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2014.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Podoloff, MD, BA principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-fluoroacetate in people with Brain Cancer and Breast Cancer, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodistribution of 18F-Fluoroacetate (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2014.