Trial Outcomes & Findings for Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer (NCT NCT02810873)
NCT ID: NCT02810873
Last Updated: 2025-05-04
Results Overview
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).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
4 hours after Cu 64 TP3805 administered
Results posted on
2025-05-04
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
13
|
|
Overall Study
COMPLETED
|
6
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer
Baseline characteristics by cohort
| Measure |
F-18-FDG Whole-body Scan
n=6 Participants
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
|
No F-18-FDG Scan
n=13 Participants
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
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
13 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 hours after Cu 64 TP3805 administeredCu-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).
Outcome measures
| Measure |
No F-18-FDG Scan
n=13 Participants
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.
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
|
F-18-FDG Whole-body Scan
n=6 Participants
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.
|
|---|---|---|
|
Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog
|
14 Number of Lesions
|
10 Number of Lesions
|
SECONDARY outcome
Timeframe: 4 hours after Cu 64 TP3805 administeredPopulation: No data were collected or reported as tumors were not extracted and histology could not be performed
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.
Outcome measures
Outcome data not reported
Adverse Events
F-18-FDG Whole-body Scan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No F-18-FDG Scan
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
F-18-FDG Whole-body Scan
n=6 participants at risk
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
|
No F-18-FDG Scan
n=13 participants at risk
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Flushing sensation
|
0.00%
0/6
|
15.4%
2/13 • Number of events 2
|
Additional Information
Dr. Mathew Thakur
Sidney Kimmel Cancer Center at Thomas Jefferson University
Phone: 215-503-7874
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place