Breast CarcinomaNCT02810873
Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer
A study testing Positron Emission Mammography, Positron Emission Tomography and Fludeoxyglucose F-18 in people with Breast Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
Trial summary
This clinical trial studies positron emission tomography imaging in using copper Cu 64 TP3805in patients with breast cancer. Diagnostic procedures, such as positron emission tomography (PET) and positron emission mammography (PEM) scan, using Cu-64-TP3805 may help doctors find and diagnose breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Positron Emission Mammography, Positron Emission Tomography and Fludeoxyglucose F-18
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Breast cancer shown with abnormal mammogram and histology verification (stage-1 patients will also need to have a positive F-18-FDG whole-body scan)
- Tumor mass of 1 cm or larger, as determined by mammography, ultrasound, or magnetic resonance imaging (MRI)
- Signed informed consent form approved by the institutional review board (IRB)
Who cannot join
- Pregnant or lactating female
- Patient with asthma
About this study
Official title: PET Imaging of Breast Cancer Using Oncogene Expression
This clinical trial studies positron emission tomography imaging in using copper Cu 64 TP3805in patients with breast cancer. Diagnostic procedures, such as positron emission tomography (PET) and positron emission mammography (PEM) scan, using Cu-64-TP3805 may help doctors find and diagnose breast cancer.
Read the detailed description
OBJECTIVES:
- The study's primary goal is to assess the ability of Cu-64-TP3805 (copper Cu 64 TP3805) to detect primary breast lesions as determined by the F-18-FDG (fludeoxyglucose F 18) scan.
II. The study's second goal is to determine the ability of Cu-64-TP3805 to detect primary breast lesions as determined by histology (sensitivity).
III. The study's third goal is to determine the ability of Cu-64-TP3805 to detect metastatic lesions as identified by the F-18-FDG whole-body scan.
OUTLINE: This is a dose-finding 2-stage study.
STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.
STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.
- Conditions
- Breast Carcinoma
- Being tested
- Positron Emission Mammography, Positron Emission Tomography, Fludeoxyglucose F-18, Copper Cu 64 TP3805
- 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 MammographyDevice
Undergo PEM Positron Emission Mammography scan
Positron Emission TomographyDevice
Also called Medical Imaging, Positron Emission Tomography, proton magnetic resonance spectroscopic imaging
Undergo PET Positron Emission Tomography scan
Fludeoxyglucose F-18Radiation
Also called 2-Deoxy-2-(18F)Fluoro-D-Glucose, 2-F18-Fluoro-2-deoxy-D-glucose, 2-F18-Fluoro-2-deoxyglucose, 105851-17-0
Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Copper Cu 64 TP3805Drug
Also called Cu-64-TP3805
Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
| Study group | Role | What they receive |
|---|---|---|
| F-18-FDG Whole body Scan | Experimental | STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan. Receives: Device: Positron Emission Mammography; Radiation: Fludeoxyglucose F-18; Drug: Copper Cu 64 TP3805 |
| No F-18-FDG Scan | Experimental | STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan. Receives: Device: Positron Emission Tomography; Radiation: Fludeoxyglucose F-18; Drug: Copper Cu 64 TP3805 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog
Cu-64 results will be compared with those of F-18-FDG for: The unit of analysis will be the lesion (with potentially multiple lesions available per patient).
Measured: 4 hours after Cu 64 TP3805 administered
Secondary outcomes (1)
Ability of Copper Cu 64 TP3805 to Detect Primary Breast Lesions as Determined by Histology (Sensitivity)
Optimal imaging time is the one (of the three) which will have least background activity in the surrounding tissue and image the maximum number of lesions with clarity. 95% confidence intervals will be used. To account for the multiplicity of lesions per patient, the GEE approach will be used, with the robust variance. Any adverse events will be summarized descriptively.
Measured: 4 hours after Cu 64 TP3805 administered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startSep 2008
- Primary completionMay 2012
- Study completionJul 2012
Why it stopped: Study terminated by PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Madhukar Thakur, PhD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810873
- Sponsor's protocol ID
- 08F.327
- Other IDs
- JT 1419
- Status last verified
- May 2025
- First submitted
- 8 Jun 2016
- Last updated
- 4 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging of Breast Cancer Using Oncogene Expression
- ClinicalTrials.gov ID
- NCT02810873
- Acronym / sponsor ID
- 08F.327
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated by PI
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 2008
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Posted 9 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies positron emission tomography imaging in using copper Cu 64 TP3805in patients with breast cancer. Diagnostic procedures, such as positron emission tomography (PET) and positron emission mammography (PEM) scan, using Cu-64-TP3805 may help doctors find and diagnose breast cancer.
Detailed description
OBJECTIVES:
- The study's primary goal is to assess the ability of Cu-64-TP3805 (copper Cu 64 TP3805) to detect primary breast lesions as determined by the F-18-FDG (fludeoxyglucose F 18) scan.
II. The study's second goal is to determine the ability of Cu-64-TP3805 to detect primary breast lesions as determined by histology (sensitivity).
III. The study's third goal is to determine the ability of Cu-64-TP3805 to detect metastatic lesions as identified by the F-18-FDG whole-body scan.
OUTLINE: This is a dose-finding 2-stage study.
STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.
STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F-18-FDG Whole body Scan | Experimental | Device: Positron Emission Mammography, Radiation: Fludeoxyglucose F-18, Drug: Copper Cu 64 TP3805STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan. |
| No F-18-FDG Scan | Experimental | Device: Positron Emission Tomography, Radiation: Fludeoxyglucose F-18, Drug: Copper Cu 64 TP3805STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Breast cancer shown with abnormal mammogram and histology verification (stage-1 patients will also need to have a positive F-18-FDG whole-body scan)
- Tumor mass of 1 cm or larger, as determined by mammography, ultrasound, or magnetic resonance imaging (MRI)
- Signed informed consent form approved by the institutional review board (IRB)
Key exclusion criteria (2 listed)
- Pregnant or lactating female
- Patient with asthma
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 MammographyUndergo PEM Positron Emission Mammography scan | Device | F-18-FDG Whole body Scan |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, proton magnetic resonance spectroscopic imagingUndergo PET Positron Emission Tomography scan | Device | No F-18-FDG Scan |
| Fludeoxyglucose F-18Also: 2-Deoxy-2-(18F)Fluoro-D-Glucose, 2-F18-Fluoro-2-deoxy-D-glucose, 2-F18-Fluoro-2-deoxyglucose, 105851-17-0Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan | Radiation | F-18-FDG Whole body Scan, No F-18-FDG Scan |
| Copper Cu 64 TP3805Also: Cu-64-TP3805Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan | Drug | F-18-FDG Whole body Scan, No F-18-FDG Scan |
Primary outcome
Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog
Time frame: 4 hours after Cu 64 TP3805 administered
Cu-64 results will be compared with those of F-18-FDG for: The unit of analysis will be the lesion (with potentially multiple lesions available per patient).
1 secondary outcome
Ability of Copper Cu 64 TP3805 to Detect Primary Breast Lesions as Determined by Histology (Sensitivity)
Time frame: 4 hours after Cu 64 TP3805 administered
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Thomas Jefferson University HospitalLink 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.
Madhukar Thakur, PhD principal investigator
Thomas Jefferson University
Questions about this trial
What is this clinical trial studying?
A study testing Positron Emission Mammography, Positron Emission Tomography and Fludeoxyglucose F-18 in people with Breast Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
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 4 inclusion and 2 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 4 May 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog (time frame: 4 hours after Cu 64 TP3805 administered). 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 4 May 2025.