Clinical trial · Interventional
Performance of Contrast-Enhanced Spectral Mammography to Assess Neoadjuvant Chemotherapy Response (CEDM)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low enrollment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Mammography | Procedure | — | UNRESOLVED |
| Low Osmolar Contrast Material, 300-399 Mg/Ml Iodine Concentration, Per Ml | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast cancer patients
- description
- Patients with ipsilateral intact biopsy-proven breast cancer
- interventionNames
- Procedure: Digital Mammography
- Drug: Low Osmolar Contrast Material, 300-399 Mg/Ml Iodine Concentration, Per Ml
Primary outcomes (6)
- measure
- Sensitivity of Predicting pCR (Pathologic Complete Response) for CEDM
- timeFrame
- 4 to 6 months from initiation of neoadjuvant therapy until final surgery
- description
- Sensitivities in predicting pCR will be calculated for CEDM and measured as AUC
- measure
- Sensitivity of Predicting pCR (Pathologic Complete Response) for Mammography
- timeFrame
- 4 to 6 months from initiation of neoadjuvant therapy until final surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available