Trial Outcomes & Findings for PET-MR for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer (NCT NCT01190566)
NCT ID: NCT01190566
Last Updated: 2015-07-07
Results Overview
Pathological complete response (pCR) or non-pCR
Recruitment status
COMPLETED
Target enrollment
57 participants
Primary outcome timeframe
Post-operation
Results posted on
2015-07-07
Participant Flow
Participant milestones
| Measure |
Pathologic Complete Responders (pCR)
The absence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
|
Non-pCR
The presence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
42
|
|
Overall Study
COMPLETED
|
6
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PET-MR for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer
Baseline characteristics by cohort
| Measure |
Pathologic Complete Responders (pCR)
n=6 Participants
The absence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
|
Non-pCR
n=42 Participants
The presence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
40 years old or less
|
2 participants
n=5 Participants
|
9 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Age, Customized
more than 40 years old
|
4 participants
n=5 Participants
|
33 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Clinical stage (American Joint Committee on Cancer 7th edition)
Stage II
|
2 participants
n=5 Participants
|
8 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Clinical stage (American Joint Committee on Cancer 7th edition)
Stage III
|
4 participants
n=5 Participants
|
34 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Estrogen receptor
Negative
|
5 participants
n=5 Participants
|
16 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Estrogen receptor
Positive
|
1 participants
n=5 Participants
|
26 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Progesterone receptor
Negative
|
5 participants
n=5 Participants
|
31 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Progesterone receptor
Positive
|
1 participants
n=5 Participants
|
11 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
HER2
Negative
|
5 participants
n=5 Participants
|
32 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
HER2
Positive
|
1 participants
n=5 Participants
|
10 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Ki-67 (Cellular marker for proliferation)
14% or less (low proliferation)
|
2 participants
n=5 Participants
|
28 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Ki-67 (Cellular marker for proliferation)
more than 14% (high proliferation)
|
4 participants
n=5 Participants
|
14 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Immunohistochemical subtype
Hormone receptor positive
|
1 participants
n=5 Participants
|
26 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Immunohistochemical subtype
Triple negative
|
4 participants
n=5 Participants
|
10 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Immunohistochemical subtype
HER2-positive
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-operationPathological complete response (pCR) or non-pCR
Outcome measures
| Measure |
Pathologic Response to Chemotherapy
n=48 Participants
Degree of pathologic response to the neoadjuvant chemotherapy
|
Non-pCR
the presence of invasive tumor cells after surgery
|
|---|---|---|
|
Patholocial Response to Chemotherapy
Pathologic completer Responders (pCR)
|
6 participants
|
—
|
|
Patholocial Response to Chemotherapy
Non-pCR
|
42 participants
|
—
|
SECONDARY outcome
Timeframe: baseline, completion of 1st cycle of chemotherapyMaximal tumor diameter measured on magnetic resonance imaging
Outcome measures
| Measure |
Pathologic Response to Chemotherapy
n=6 Participants
Degree of pathologic response to the neoadjuvant chemotherapy
|
Non-pCR
n=42 Participants
the presence of invasive tumor cells after surgery
|
|---|---|---|
|
Tumor Size
Baseline tumor size
|
4.9 cm
Standard Deviation 1.8
|
5.0 cm
Standard Deviation 2.0
|
|
Tumor Size
Post-1st chemotherapy tumor size
|
4.2 cm
Standard Deviation 1.8
|
4.5 cm
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline, post-1st chemotherapyTumor volume measured on 3-dimensional magnetic resonance imaging
Outcome measures
| Measure |
Pathologic Response to Chemotherapy
n=6 Participants
Degree of pathologic response to the neoadjuvant chemotherapy
|
Non-pCR
n=42 Participants
the presence of invasive tumor cells after surgery
|
|---|---|---|
|
Tumor Volume
Baseline
|
22.0 cm3
Standard Deviation 18.7
|
38.9 cm3
Standard Deviation 89.8
|
|
Tumor Volume
Post-1st chemotherapy
|
11.0 cm3
Standard Deviation 13.2
|
26.4 cm3
Standard Deviation 44.4
|
SECONDARY outcome
Timeframe: Baseline, post-1st chemotherapyParametric response map analysis using a software calculates the interval change of signal intensity based on a voxel-to-voxel comparison between measurements at baseline and after the first cycle of chemotherapy. PRMSI+ indicates proportions of voxels within a tumor with increased signal intensity. PRMSI- indicates proportions of voxels within a tumor with decreased signal intensity. PRMSI0 indicates proportions of voxels within a tumor with unchanged signal intensity.
Outcome measures
| Measure |
Pathologic Response to Chemotherapy
n=6 Participants
Degree of pathologic response to the neoadjuvant chemotherapy
|
Non-pCR
n=42 Participants
the presence of invasive tumor cells after surgery
|
|---|---|---|
|
Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI)
PRMSI+
|
14.0 % of voxels
Standard Deviation 6.5
|
40.7 % of voxels
Standard Deviation 27.2
|
|
Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI)
PRMSI-
|
83.4 % of voxels
Standard Deviation 7.6
|
56.4 % of voxels
Standard Deviation 27.8
|
|
Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI)
PRMSI0
|
2.7 % of voxels
Standard Deviation 1.4
|
2.9 % of voxels
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline, post-1st chemotherapyOutcome measures
| Measure |
Pathologic Response to Chemotherapy
n=6 Participants
Degree of pathologic response to the neoadjuvant chemotherapy
|
Non-pCR
n=42 Participants
the presence of invasive tumor cells after surgery
|
|---|---|---|
|
Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans)
Baseline Ktrans
|
0.263 min-1
Standard Deviation 0.044
|
0.254 min-1
Standard Deviation 0.080
|
|
Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans)
Post-1st chemotherapy Ktrans
|
0.224 min-1
Standard Deviation 0.076
|
0.234 min-1
Standard Deviation 0.068
|
SECONDARY outcome
Timeframe: Baseline, post-1st chemotherapyOutcome measures
| Measure |
Pathologic Response to Chemotherapy
n=6 Participants
Degree of pathologic response to the neoadjuvant chemotherapy
|
Non-pCR
n=42 Participants
the presence of invasive tumor cells after surgery
|
|---|---|---|
|
Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep)
Baseline
|
0.616 min-1
Standard Deviation 0.262
|
0.787 min-1
Standard Deviation 0.729
|
|
Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep)
Post-1st chemotherapy
|
0.992 min-1
Standard Deviation 0.917
|
0.616 min-1
Standard Deviation 0.298
|
SECONDARY outcome
Timeframe: Baseline, post-1st chemotherapyOutcome measures
| Measure |
Pathologic Response to Chemotherapy
n=6 Participants
Degree of pathologic response to the neoadjuvant chemotherapy
|
Non-pCR
n=42 Participants
the presence of invasive tumor cells after surgery
|
|---|---|---|
|
Extracellular Extravascular Space Per Unit Volume of Tissue (Ve)
Baseline
|
0.563 unitless
Standard Deviation 0.129
|
0.550 unitless
Standard Deviation 0.146
|
|
Extracellular Extravascular Space Per Unit Volume of Tissue (Ve)
Post-1st chemotherapy
|
0.467 unitless
Standard Deviation 0.151
|
0.557 unitless
Standard Deviation 0.136
|
SECONDARY outcome
Timeframe: Baseline, post-1st chemotherapyPopulation: Of the 48 participants, 13 participants did not undergo magnetic resonance spectroscopy examinations due to workflow problem. We included the available data from 35 participants.
Single voxel 1H-magnetic resonance spectroscopy quantifies the amount of total choline-containing compounds of a tumor, which indicates cellular proliferation and malignant transformation.
Outcome measures
| Measure |
Pathologic Response to Chemotherapy
n=6 Participants
Degree of pathologic response to the neoadjuvant chemotherapy
|
Non-pCR
n=29 Participants
the presence of invasive tumor cells after surgery
|
|---|---|---|
|
Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy
Baseline
|
15.0 unitless
Standard Deviation 8.4
|
13.5 unitless
Standard Deviation 11.5
|
|
Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy
Post-1st chemotherapy
|
3.4 unitless
Standard Deviation 2.8
|
7.8 unitless
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline, post-1st chemotherapyOutcome measures
| Measure |
Pathologic Response to Chemotherapy
n=6 Participants
Degree of pathologic response to the neoadjuvant chemotherapy
|
Non-pCR
n=29 Participants
the presence of invasive tumor cells after surgery
|
|---|---|---|
|
Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography
Baseline
|
18.9 unitless
Standard Deviation 12.1
|
10.7 unitless
Standard Deviation 5.6
|
|
Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography
Post-1st chemotherapy
|
9.7 unitless
Standard Deviation 10.7
|
7.6 unitless
Standard Deviation 4.4
|
Adverse Events
Pathologic Complete Responders (pCR)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-pCR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place