A Phase 4 interventional study of Digital Mammography and Low Osmolar Contrast Material, 300-399 Mg/Ml Iodine Concentration, Per Ml in Breast Cancer, sponsored by University of Texas Southwestern Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-12.
Sponsored by University of Texas Southwestern Medical Center · Phase 4, Interventional, and Diagnostic
This study is designed to investigate the diagnostic accuracy of Contrast Enhanced Spectral Mammography (CEDM) in predicting early neoadjuvant therapy response and pathologic complete response (pCR) compared to mammography.
Patients diagnosed with invasive breast cancer with available mammography and ultrasound imaging are eligible for the study.
Eligible patients will be imaged at baseline (before initiation of neoadjuvant chemotherapy or endocrine therapy), early (2-4 cycles of neoadjuvant therapy) and late (after completion of neoadjuvant chemotherapy or endocrine therapy) timepoints with mammography. CEDM will be done within 2 weeks of the specified timepoint. Additionally, a survey of subject experience with CEDM and other pre-operative imaging will be collected after CEDM is performed.
The use of neoadjuvant systemic therapy in the treatment of breast cancer patients is increasing beyond the scope of locally advanced disease. Imaging provides important information in assessing response to therapy as a complement to conventional tumor measurements via physical examination. Tumor response to neoadjuvant therapy can also provide prognostic information. The attainment of pCR after completion of neoadjuvant therapy and surgical resection is associated with improved disease-free survival. This correlation is especially strong for Triple-receptor negative and human epidermal growth factor receptor 2 (HER-2) positive breast cancer. Studies of neoadjuvant therapy have used a variety of methods for assessing tumor response. Currently, there are no established clinical practice guidelines for how best to assess tumor response to neoadjuvant therapy. Typically, patients undergo conventional breast imaging such as mammography and ultrasonography (US) and physical examination, and dynamic contrast-enhanced breast magnetic resonance imaging (DCR-MRI) in selected cases.
Contrast Enhanced Digital Mammography (CEDM) is a novel imaging technique, which allows digital mammography to be used with contrast enhancement to depict cancers that would otherwise be occult on standard unenhanced mammography. CEDM is performed with and without intravenous iodine contrast, using the dual energy subtraction technique. Compared with mammography and US, CEDM improves the sensitivity for breast cancer detection without decreasing specificity. CEDM digital detector has higher spatial resolution than MRI, revealing details that are approximately 10 times better. In contrast to the rapid washout in MRI, enhancement on CEDM in fact persists for at least 10 min after contrast agent infusion. Today CEDM is available commercially for clinical use. It is estimated that over 200,000 CEDM examinations have been performed to date in both research and clinical settings. CEDM costs significantly less compared to MRI. Furthermore, longer time delays between contrast injection and CEDM exposure could result in stronger enhancement and hence better visibility compared to MRI, especially given the much higher spatial resolution of digital mammography. It is unknown whether CEDM can improve the sensitivity of mammography in the early assessment of neoadjuvant therapy response. We hypothesize that CEDM is superior to mammography and ultrasound in assessing early response, and pre-surgical residual cancer after neoadjuvant therapy, and when performed, non-inferior to MRI in assessing the residual disease using the metrics of pCR and residual cancer burden (RCB).
University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 101 (75%) have results posted.
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Exclusion Criteria:
Patients with ipsilateral intact biopsy-proven breast cancer
Procedure: Digital Mammography · Drug: Low Osmolar Contrast Material, 300-399 Mg/Ml Iodine Concentration, Per Ml
Digital Mammography enhanced with an iodinated contrast agent
Injection of low osmolar contrast material during the digital mammography exam
Sensitivity of Predicting pCR (Pathologic Complete Response) for CEDM
Sensitivities in predicting pCR will be calculated for CEDM and measured as AUC
Time frame: 4 to 6 months from initiation of neoadjuvant therapy until final surgery
Sensitivity of Predicting pCR (Pathologic Complete Response) for Mammography
Sensitivities in predicting pCR will be calculated for mammography measured as AUC
Time frame: 4 to 6 months from initiation of neoadjuvant therapy until final surgery
Specificity of Predicting pCR (Pathologic Complete Response) for CEDM
Specificity of predicting pCR will be calculated for CEDM and measured as AUC
Time frame: 4 to 6 months from initiation of neoadjuvant therapy until final surgery
Specificity of Predicting pCR (Pathologic Complete Response) for Mammography
Specificity of predicting pCR will be calculated for mammography and measured as AUC
Time frame: 4 to 6 months from initiation of neoadjuvant therapy until final surgery
Diagnostic Accuracy of Contrast-enhanced Mammography in Assessing pCR or Non Response
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.
Time frame: 4 to 6 months from initiation of neoadjuvant therapy until final surgery
Correlation of Residual Tumor Size With Pathologic Size
Spearman's rank correlation will be used to measure the association between final pathologic and imaging tumor size
Time frame: 4 to 6 months from initiation of neoadjuvant therapy until final surgery
| Milestone | Breast Cancer Patients |
|---|---|
| Started | 6 |
| Completed | 3 |
| Not completed | 3 |
Sensitivities in predicting pCR will be calculated for CEDM and measured as AUC
No measurements were reported for this outcome.
Sensitivities in predicting pCR will be calculated for mammography measured as AUC
No measurements were reported for this outcome.
Specificity of predicting pCR will be calculated for CEDM and measured as AUC
No measurements were reported for this outcome.
Specificity of predicting pCR will be calculated for mammography and measured as AUC
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Spearman's rank correlation will be used to measure the association between final pathologic and imaging tumor size
No measurements were reported for this outcome.
Collected over At least 30 minutes after contrast administration. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Breast Cancer Patients | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Breast Cancer Patients |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Breast Cancer Patients |
|---|---|
| Female | 6 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Breast Cancer Patients |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Breast Cancer Patients |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Breast Cancer Patients |
|---|---|
| United States | 6 |
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University of Texas Southwestern Medical Center