N/A
Completed N=17
Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy
Source: ClinicalTrials.gov NCT02115607 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Complete Responders — 3.23; 1.67 dB
Summary
This is a diagnostic accuracy study to evaluate if two novel ultrasound (US) techniques, quantitative 3D subharmonic imaging (SHI) and Subharmonic Aided Pressure Estimation (SHAPE), used with an intravenous ultrasound contrast agent (Definity, Lantheus Medical Imaging, Billerica, MA), can track changes in locally advanced breast cancer (LABC) angiogenesis and interstitial fluid pressure (IFP), respectively, by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% and 60% (in part 1) or 30% (in part 2) of the neoadjuvant chemotherapy treatment delivered and after completion of the neoadjuvant chemotherapy treatment. Results will be compared to MRI and pathology.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Complete Responders |
3.23; 1.67 | — |
| PRIMARY Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Partial Responders |
-0.88; 0.06 | — |
| SECONDARY Subharmonic Imaging (SHI) Depiction of Breast Cancer Angiogenesis for Complete Responders |
1.1 | — |
| SECONDARY SHI Depiction of Breast Cancer Angiogenesis for Partial Responders |
— | — |
Eligibility Criteria
Inclusion Criteria
- Females
- Be diagnosed with T1 or greater LABC, any N and M0.
- Be scheduled for neoadjuvant chemotherapy
- Be at least 21 years of age.
- Be medically stable.
- If a female of child-bearing potential, must have a negative pregnancy test.
- Have signed Informed Consent to participate in the study.
Exclusion Criteria
- Males
- Females who are pregnant or nursing.
- Patients with other primary cancers requiring systemic treatment.
- Patients with any metastatic disease.
- Patients undergoing neoadjuvant endocrine therapy.
- Patients with known hypersensitivity or allergy to any component of Definity.
- Patients with cardiac shunts or congenital heart defects.
- Patients with unstable cardiopulmonary conditions or respiratory distress syndrome.
- Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli.
- Patients who have received any contrast medium (X-ray, MRI, CT or US) in the 24 hours prior to the research US exam.
Data sourced from ClinicalTrials.gov (NCT02115607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.