Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 9/22/2018 |
| Start Date: | March 2014 |
| End Date: | January 2020 |
Quantitative Subharmonic Breast Imaging: Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy
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.
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.
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.
We found this trial at
1
site
1020 Walnut St
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-955-4870
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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