Trial Outcomes & Findings for Monitoring and Predicting Chemotherapy Response Using DOSI (NCT NCT01217385)
NCT ID: NCT01217385
Last Updated: 2023-01-17
Results Overview
This measure will look at the Accuracy of % change in DOSI measured Tumor Optical Index (TOI) from baseline to mid therapy to predict pathologic response (pCR+ v pCR-) Pathologic response (dichotomized into responders (pCR+) and non-responders (pCR-) based pathologic assessment) will be used as the reference standard and Accuracy will be determined using receiver operating characteristic (ROC) analysis to determine the ROC Area Under the Curve (AUC).
COMPLETED
NA
60 participants
From baseline to mid-therapy
2023-01-17
Participant Flow
Seven institutions were approved to enroll a total of 60 female breast cancer patients: Enrollment began in June 2011 and completed in June 2013. All institutions activated concurrently, except MD Anderson Cancer Center and Boston University, which joined the study in January and May 2013, respectively.
Participant milestones
| Measure |
Diffuse Optical Spectroscopy Imaging (DOSI)
Participants undergo approximately four assessments of breast health using the Diffuse optical spectroscopy imaging (DOSI)technology during treatment and prior to surgery for breast cancer.
DOSI: Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during neoadjuvant chemotherapy (NAC) treatment.
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|---|---|
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Overall Study
STARTED
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60
|
|
Overall Study
COMPLETED
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34
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
Diffuse Optical Spectroscopy Imaging (DOSI)
Participants undergo approximately four assessments of breast health using the Diffuse optical spectroscopy imaging (DOSI)technology during treatment and prior to surgery for breast cancer.
DOSI: Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during neoadjuvant chemotherapy (NAC) treatment.
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|---|---|
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Overall Study
Withdrawal by Subject
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3
|
|
Overall Study
DOSI not performed/not eval
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12
|
|
Overall Study
Central Path not Available
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1
|
|
Overall Study
Normal Breast TOI not available
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10
|
Baseline Characteristics
Monitoring and Predicting Chemotherapy Response Using DOSI
Baseline characteristics by cohort
| Measure |
Diffuse Optical Spectroscopy Imaging (DOSI)
n=34 Participants
Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.
DOSI: Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during neoadjuvant Chemotherapy (NAC) treatment.
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|---|---|
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Age, Continuous
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48.4 years
STANDARD_DEVIATION 10.7 • n=5 Participants
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|
Sex: Female, Male
Female
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34 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Histologic findings
Invasive (infiltrating) ductal carcinoma (IDC)
|
16 Participants
n=5 Participants
|
|
Histologic findings
Invasive lobular carcinoma (ILC)
|
3 Participants
n=5 Participants
|
|
Histologic findings
Ductal Carcinoma In Situ (DCIS)/ILC
|
11 Participants
n=5 Participants
|
|
Histologic findings
IDC/ILC
|
2 Participants
n=5 Participants
|
|
Histologic findings
Other/not available
|
2 Participants
n=5 Participants
|
|
estrogen receptor (ER) status
Positive
|
24 Participants
n=5 Participants
|
|
estrogen receptor (ER) status
Negative
|
7 Participants
n=5 Participants
|
|
estrogen receptor (ER) status
Unknown
|
3 Participants
n=5 Participants
|
|
progesterone receptor (PR) status
Positive
|
19 Participants
n=5 Participants
|
|
progesterone receptor (PR) status
Negative
|
12 Participants
n=5 Participants
|
|
progesterone receptor (PR) status
Unknown
|
3 Participants
n=5 Participants
|
|
cell division marker (Ki67) status
Positive
|
17 Participants
n=5 Participants
|
|
cell division marker (Ki67) status
Negative
|
2 Participants
n=5 Participants
|
|
cell division marker (Ki67) status
Unknown
|
15 Participants
n=5 Participants
|
|
hormone receptor 2 (Her2/neu) status from Immunohistochemistry (IHC):
0 - HER2-negative
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4 Participants
n=5 Participants
|
|
hormone receptor 2 (Her2/neu) status from Immunohistochemistry (IHC):
1 - HER2-negative
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8 Participants
n=5 Participants
|
|
hormone receptor 2 (Her2/neu) status from Immunohistochemistry (IHC):
2 - equivocal
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8 Participants
n=5 Participants
|
|
hormone receptor 2 (Her2/neu) status from Immunohistochemistry (IHC):
3 - HER2-positive
|
4 Participants
n=5 Participants
|
|
hormone receptor 2 (Her2/neu) status from Immunohistochemistry (IHC):
unknown/not available
|
10 Participants
n=5 Participants
|
|
fluorescence in situ hybridization (FISH) status
Amplified
|
7 Participants
n=5 Participants
|
|
fluorescence in situ hybridization (FISH) status
Non amplified
|
14 Participants
n=5 Participants
|
|
fluorescence in situ hybridization (FISH) status
Unknown/not available
|
13 Participants
n=5 Participants
|
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Areolar tumor
Areolar tumor
|
17 Participants
n=5 Participants
|
|
Areolar tumor
Nonareolar tumor
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17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to mid-therapyPopulation: Bedside DOSI images of the tissue concentrations of TOI (ctHHb x tH2O/lipid) acquired on both breasts at baseline and mid-therapy during neoadjuvant chemotherapy (NAC) treatment.
This measure will look at the Accuracy of % change in DOSI measured Tumor Optical Index (TOI) from baseline to mid therapy to predict pathologic response (pCR+ v pCR-) Pathologic response (dichotomized into responders (pCR+) and non-responders (pCR-) based pathologic assessment) will be used as the reference standard and Accuracy will be determined using receiver operating characteristic (ROC) analysis to determine the ROC Area Under the Curve (AUC).
Outcome measures
| Measure |
Diffuse Optical Spectroscopy Imaging (DOSI
n=34 Participants
Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.
DOSI: Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during NAC treatment.
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PR- Participants
Participants who are Progesterone Receptor Negative (PR-)
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PR? Participants
Participants whose PR status is unknown
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|---|---|---|---|
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Accuracy of %Change in TOI Between Baseline and Mid-therapy to Predict Pathologic Response (pCR +/-)
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0.60 probability
Interval 0.39 to 0.81
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—
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—
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SECONDARY outcome
Timeframe: baseline to mid-therapyPopulation: Analysis population consists of the 34 participants with both baseline and mid-therapy TOI measurements.
Pathologic Complete response vs Non-Complete response, by PR status Progesterone Receptor Status (positive, negative, unknown ) is determined at pathological assessment of the tumor sample. %change in TOI is evaluated from baseline to mid-therapy.
Outcome measures
| Measure |
Diffuse Optical Spectroscopy Imaging (DOSI
n=19 Participants
Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.
DOSI: Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during NAC treatment.
|
PR- Participants
n=12 Participants
Participants who are Progesterone Receptor Negative (PR-)
|
PR? Participants
n=3 Participants
Participants whose PR status is unknown
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|---|---|---|---|
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%Change in TOI Between Baseline and Mid-therapy to Predict pCR+; Stratified by Progesterone Receptor (PR) Status (Positive, Negative, Unknown )
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-29.874 percentage change
Standard Deviation 31.349
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-14.605 percentage change
Standard Deviation 107.425
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-45.701 percentage change
Standard Deviation 25.237
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SECONDARY outcome
Timeframe: baseline to mid-therapyPopulation: evaluable subjects with baseline tumor StO2 dichotomized at 76.9%. (i.e. population median) and %change TOI dichotomized at -40%
subset analysis, subjects were stratified using the median tumor StO2 %change TOI Between Baseline and Mid-therapy dichotomized at -40% stratified by the set evaluable subjects with baseline tumor StO2 dichotomized at 76.9%. (i.e. population median). Accuracy will be determined using ROC analysis to determine the ROC Area Under the Curve (AUC).
Outcome measures
| Measure |
Diffuse Optical Spectroscopy Imaging (DOSI
n=17 Participants
Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.
DOSI: Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during NAC treatment.
|
PR- Participants
n=17 Participants
Participants who are Progesterone Receptor Negative (PR-)
|
PR? Participants
Participants whose PR status is unknown
|
|---|---|---|---|
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Accuracy of %Change in TOI Between Baseline and Mid-therapy to Predict pCR+; Stratified by Oxygen Saturation (St02)
|
0.38 probability
Interval 0.08 to 0.68
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0.83 probability
Interval 0.63 to 1.0
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—
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SECONDARY outcome
Timeframe: baseline to mid-therapyPopulation: participants having TOI ratio (T/N) using tumor breast normal at baseline and mid-therapy and have pathologic response data.
Determine the optimal cutpoint (aka Youden-index) for %Change in TOI ratio (T/N) to maximize sensitivity and specificity in the predication of pCR
Outcome measures
| Measure |
Diffuse Optical Spectroscopy Imaging (DOSI
n=44 Participants
Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.
DOSI: Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during NAC treatment.
|
PR- Participants
Participants who are Progesterone Receptor Negative (PR-)
|
PR? Participants
Participants whose PR status is unknown
|
|---|---|---|---|
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Estimate the Optimal Cutpoint for %Change in TOI From Baseline to Mid-therapy to Predict pCR
|
-32.527 percentage change in TOI
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—
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—
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Adverse Events
DOSI
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Donna Hartfeil, Director Protocol Management
American College of Radiology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place