Breast Carcinoma
Conditions
Brief 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.
Detailed description
OBJECTIVES: I. 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.
Interventions
Undergo PEM Positron Emission Mammography scan
DEVICEPositron Emission Tomography
Undergo PET Positron Emission Tomography scan
RADIATIONFludeoxyglucose F-18
Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Sponsors
National Institutes of Health (NIH)
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* Pregnant or lactating female * Patient with asthma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ability of Copper Cu 64 TP3805 to Detect Primary Breast Lesions as Determined by Histology (Sensitivity) | 4 hours after Cu 64 TP3805 administered | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| F-18-FDG Whole-body Scan 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.
Positron Emission Mammography: Undergo PEM Positron Emission Mammography scan
Positron Emission Tomography: Undergo PET Positron Emission Tomography scan
Fludeoxyglucose F-18: Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Copper Cu 64 TP3805: Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan | 6 |
| No F-18-FDG Scan 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.
Positron Emission Mammography: Undergo PEM Positron Emission Mammography scan
Positron Emission Tomography: Undergo PET Positron Emission Tomography scan
Fludeoxyglucose F-18: Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Copper Cu 64 TP3805: Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan | 13 |
| Total | 19 |
Baseline characteristics
| Characteristic | F-18-FDG Whole-body Scan | No F-18-FDG Scan | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 3 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 10 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 12 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 7 Participants | 11 Participants |
| Region of Enrollment United States | 6 participants | 13 participants | 19 participants |
| Sex: Female, Male Female | 6 Participants | 13 Participants | 19 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 13 |
| other Total, other adverse events | 0 / 6 | 2 / 13 |
| serious Total, serious adverse events | 0 / 6 | 0 / 13 |
Outcome results
Primary
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).
Time frame: 4 hours after Cu 64 TP3805 administered
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| F-18-FDG Whole-body Scan | Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog | 10 Number of Lesions |
| No F-18-FDG Scan | Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog | 14 Number of Lesions |
Secondary
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.
Time frame: 4 hours after Cu 64 TP3805 administered
Population: No data were collected or reported as tumors were not extracted and histology could not be performed