Breast Cancer Clinical Trial
Official title:
Performance of Contrast-Enhanced Spectral Mammography to Assess Neoadjuvant Chemotherapy Response (CEDM)
Verified date | October 2023 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | June 15, 2022 |
Est. primary completion date | June 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Ipsilateral intact biopsy-proven breast cancer clinical stage T1-T4 (by imaging) - Available mammography and ultrasound imaging of the existing index cancer, with orthogonal measurements - Prior history of ipsilateral or contralateral breast cancer, presenting with a new primary or recurrent disease - Patients who were determined to be candidates for either neoadjuvant chemotherapy or neoadjuvant endocrine therapy by the treating physician - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Exclusion Criteria: - History of ipsilateral mastectomy - Women who already started neoadjuvant chemotherapy or endocrine therapy - Woman who may be pregnant or nursing an infant - Prior history of anaphylactic or anaphylactoid reaction to any contrast. - Prior allergy to iodine or iodinated contrast. - Impaired renal function measured by estimated glomerular filtration rate (eGFR) < 60 milliliters per minute. - Patients with known distant metastasis. |
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of Predicting pCR (Pathologic Complete Response) for CEDM | Sensitivities in predicting pCR will be calculated for CEDM and measured as AUC | 4 to 6 months from initiation of neoadjuvant therapy until final surgery | |
Primary | Sensitivity of Predicting pCR (Pathologic Complete Response) for Mammography | Sensitivities in predicting pCR will be calculated for mammography measured as AUC | 4 to 6 months from initiation of neoadjuvant therapy until final surgery | |
Primary | Specificity of Predicting pCR (Pathologic Complete Response) for CEDM | Specificity of predicting pCR will be calculated for CEDM and measured as AUC | 4 to 6 months from initiation of neoadjuvant therapy until final surgery | |
Primary | Specificity of Predicting pCR (Pathologic Complete Response) for Mammography | Specificity of predicting pCR will be calculated for mammography and measured as AUC | 4 to 6 months from initiation of neoadjuvant therapy until final surgery | |
Primary | 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. | 4 to 6 months from initiation of neoadjuvant therapy until final surgery | |
Primary | 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 | 4 to 6 months from initiation of neoadjuvant therapy until final surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Recruiting |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |