Trial Outcomes & Findings for Performance of Contrast-Enhanced Spectral Mammography to Assess Neoadjuvant Chemotherapy Response (CEDM) (NCT NCT04625517)
NCT ID: NCT04625517
Last Updated: 2023-10-12
Results Overview
Sensitivities in predicting pCR will be calculated for CEDM and measured as AUC
TERMINATED
PHASE4
6 participants
4 to 6 months from initiation of neoadjuvant therapy until final surgery
2023-10-12
Participant Flow
Participant milestones
| Measure |
Breast Cancer Patients
Patients with ipsilateral intact biopsy-proven breast cancer
Digital Mammography: Digital Mammography enhanced with an iodinated contrast agent
Low Osmolar Contrast Material, 300-399 Mg/Ml Iodine Concentration, Per Ml: Injection of low osmolar contrast material during the digital mammography exam
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Performance of Contrast-Enhanced Spectral Mammography to Assess Neoadjuvant Chemotherapy Response (CEDM)
Baseline characteristics by cohort
| Measure |
Breast Cancer Patients
n=6 Participants
Patients with ipsilateral intact biopsy-proven breast cancer
Digital Mammography: Digital Mammography enhanced with an iodinated contrast agent
Low Osmolar Contrast Material, 300-399 Mg/Ml Iodine Concentration, Per Ml: Injection of low osmolar contrast material during the digital mammography exam
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 4 to 6 months from initiation of neoadjuvant therapy until final surgeryPopulation: The number of participants with outcomes in our trial was limited to only three. Furthermore, none of the patients had pCR -hence none of the cases have the reference standard needed to calculate this parameter (sensitivity).
Sensitivities in predicting pCR will be calculated for CEDM and measured as AUC
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 to 6 months from initiation of neoadjuvant therapy until final surgeryPopulation: The number of participants with outcomes in our trial was limited to only three. Furthermore, none of the patients had pCR -hence none of the cases have the reference standard needed to calculate this parameter (sensitivity).
Sensitivities in predicting pCR will be calculated for mammography measured as AUC
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 to 6 months from initiation of neoadjuvant therapy until final surgeryPopulation: The number of participants with outcomes in our trial was limited to only three. Furthermore, none of the patients had pCR -hence none of the cases have the reference standard needed to calculate this parameter (specificity).
Specificity of predicting pCR will be calculated for CEDM and measured as AUC
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 to 6 months from initiation of neoadjuvant therapy until final surgeryPopulation: The number of participants with outcomes in our trial was limited to only three. Furthermore, none of the patients had pCR -hence none of the cases have the reference standard needed to calculate this parameter (specificity).
Specificity of predicting pCR will be calculated for mammography and measured as AUC
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 to 6 months from initiation of neoadjuvant therapy until final surgeryPopulation: The number of participants with outcomes in our trial was limited to only three. Furthermore, none of the patients had pCR - hence absence of reference standard end point precludes this assessment.
ROC analysis will be used to assess the diagnostic performance of CEDM. The Area under the receiver operating characteristic (ROC) curve (AUC) will be compared. A leave-one-out cross validation algorithm will be used to reduce bias from overfitting.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 to 6 months from initiation of neoadjuvant therapy until final surgeryPopulation: The number of participants with outcomes in our trial was limited to only three. Furthermore, none of the patients had pCR -hence none of the cases have the reference standard needed to calculate this parameter.
Spearman's rank correlation will be used to measure the association between final pathologic and imaging tumor size
Outcome measures
Outcome data not reported
Adverse Events
Breast Cancer Patients
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