Breast CancerPhase 1NCT00584753
Molecular Imaging of Breast Cancer With Breast PET/CT
A Phase 1 study testing Positron emission tomography and computed tomography in people with Breast Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
This study is a feasibility study to determine if a combined breast PET/CT scanner can image malignant functional activity while determining anatomical structure in the same clinical setting for patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Positron emission tomography and computed tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jul 2011
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal Adult Volunteers
- Female, at least 18 years of age
- Ability to lie motionless for up to 20 minutes
- Patient Volunteers
- Female, at least 18 years of age
- Diagnostic findings from prior mammography highly suggestive of invasive breast carcinoma (BI-RADS category 5)
- Not pregnant or breast-feeding
- Ability to lie motionless for up to 20 minutes
Who cannot join
- Normal Adult Volunteers
- Inability to understand the risks and benefits of the study
- Patient Volunteers
- Recent breast biopsy
- Diagnostic findings from prior mammography highly suggestive of noninvasive ductal or lobular carcinoma
- Uncontrolled diabetes
Show all 9Show fewer
- Diabetic and blood sugar level > 200 mg/dL
- Positive urine pregnancy test or currently breast-feeding
- Inability to understand the risks and benefits of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
UC David Medical Center
Sacramento, California, 95817
About this study
This study is a feasibility study to determine if a combined breast PET/CT scanner can image malignant functional activity while determining anatomical structure in the same clinical setting for patients with breast cancer. End-points of this study are whether women will accept the imaging position and timing, and whether functional properties of breast cancer can be imaged with this device. The secondary purpose of this study is to explore protocol parameters with a view to optimizing imaging performance whilst minimizing patient discomfort. Imaging results will be compared to histological samples to determine ground truth.
Read the detailed description
PET is literally a molecular imaging modality. In monitoring the patient's response to a specific chemotherapeutic regime, baseline and subsequent PET/CT scans can be used to quantitatively determine the therapeutic effect of the regime, using the standard uptake value (SUV), a common metric in PET imaging. The breast PET/CT system will facilitate molecular imaging of breast cancer using a number of radiolabeled molecules, available both commercially (18-FDG) and from the research environment.
- Conditions
- Breast Cancer
- Being tested
- Positron emission tomography and computed tomography
- Keywords
- Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron emission tomography and computed tomographyRadiation
Also called Breast imaging
Positron emission tomography and computed tomography
Positron emission tomography and computed tomographyRadiation
Also called Breast imaging
Positron emission tomography and computed tomography
Positron emission tomography and computed tomographyRadiation
Also called Breast imaging
Positron emission tomography and computed tomography
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Normal volunteers Receives: Radiation: Positron emission tomography and computed tomography |
| 2 | Active comparator | Breast PET/CT scan Receives: Radiation: Positron emission tomography and computed tomography |
| 3 | Active comparator | Whole body and breast PET/CT Receives: Radiation: Positron emission tomography and computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-points of this study are whether women will accept the imaging position and timing, and whether functional properties of breast cancer can be imaged with this device.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startApr 2007
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramsey Badawi, Ph.D, University of California, Davis
- Investigators
- Ramsey Badawi, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584753
- Sponsor's protocol ID
- 200715040
- Status last verified
- Jan 2013
- First submitted
- 26 Dec 2007
- Last updated
- 14 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging of Breast Cancer With Breast PET/CT
- ClinicalTrials.gov ID
- NCT00584753
- Acronym / sponsor ID
- 200715040
- Conditions
- Breast Cancer
- Keywords
- Breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 2 Jan 2008 (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.
This study is a feasibility study to determine if a combined breast PET/CT scanner can image malignant functional activity while determining anatomical structure in the same clinical setting for patients with breast cancer. End-points of this study are whether women will accept the imaging position and timing, and whether functional properties of breast cancer can be imaged with this device. The secondary purpose of this study is to explore protocol parameters with a view to optimizing imaging performance whilst minimizing patient discomfort. Imaging results will be compared to histological samples to determine ground truth.
Detailed description
PET is literally a molecular imaging modality. In monitoring the patient's response to a specific chemotherapeutic regime, baseline and subsequent PET/CT scans can be used to quantitatively determine the therapeutic effect of the regime, using the standard uptake value (SUV), a common metric in PET imaging. The breast PET/CT system will facilitate molecular imaging of breast cancer using a number of radiolabeled molecules, available both commercially (18-FDG) and from the research environment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Radiation: Positron emission tomography and computed tomographyNormal volunteers |
| 2 | Active comparator | Radiation: Positron emission tomography and computed tomographyBreast PET/CT scan |
| 3 | Active comparator | Radiation: Positron emission tomography and computed tomographyWhole body and breast PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Normal Adult Volunteers
- Female, at least 18 years of age
- Ability to lie motionless for up to 20 minutes
- Patient Volunteers
- Female, at least 18 years of age
Key exclusion criteria (9 listed)
- Normal Adult Volunteers
- Patient Volunteers
- Recent breast biopsy
- Diagnostic findings from prior mammography highly suggestive of noninvasive ductal or lobular carcinoma
- Uncontrolled diabetes
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 |
|---|---|---|
| Positron emission tomography and computed tomographyAlso: Breast imagingPositron emission tomography and computed tomography | Radiation | 3 |
| Positron emission tomography and computed tomographyAlso: Breast imagingPositron emission tomography and computed tomography | Radiation | 2 |
| Positron emission tomography and computed tomographyAlso: Breast imagingPositron emission tomography and computed tomography | Radiation | 1 |
Primary outcome
End-points of this study are whether women will accept the imaging position and timing, and whether functional properties of breast cancer can be imaged with this device.
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2013.
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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.
Ramsey Badawi, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Positron emission tomography and computed tomography in people with Breast Cancer, run by University of California, Davis at 1 site in United States.
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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
End-points of this study are whether women will accept the imaging position and timing, and whether functional properties of breast cancer can be imaged with this device. (time frame: 5 years). 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 14 Jan 2013.