Contrast-Enhanced Subharmonic Ultrasound Imaging in Improving Characterization of Adnexal Masses in Patients Undergoing Surgery

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase: Completed; Early Phase 1

Conditions: Adnexal Mass

Treatments: Procedure: Contrast-Enhanced Subharmonic Ultrasound Imaging; Drug: Perflutren Lipid Microspheres

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03297112

16F.394

R21CA190930 (U.S. NIH Grant/Contract)

JT 9149 (Other Identifier)

Details and patient eligibility

About

This pilot clinical trial studies how well contrast-enhanced subharmonic ultrasound imaging works in improving the characterization of adnexal masses in patients undergoing surgery. Contrast-enhanced subharmonic ultrasound imaging uses high-frequency sound waves to produce images of internal organs and when combined with an ultrasound agent such as perflutren lipid microspheres, may help improve imaging and management of adnexal masses.

Full description

PRIMARY OBJECTIVES:

I. To develop qualitative subharmonic imaging (SHI) or SHI-derived quantitative biomarkers.

II. To generate pilot data for a study to evaluate if they improve the characterization of benign and malignant adnexal masses compared to standard ultrasound or contrast enhanced magnetic resonance imaging (MRI) or the risk of malignancy index (RMI).

SECONDARY OBJECTIVES:

I. To compare the SHI depiction of adnexal masses' neovascularity in humans to intra-tumoral microvascular density (iMVD) obtained from CD31 an immunohistochemical marker of angiogenesis.

Enrollment: 12 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be diagnosed with an adnexal mass
• Be scheduled for surgery to remove the adnexal mass
• Be clinically stable
• If a female of child-bearing potential, must have a negative pregnancy test
• Be conscious and able to comply with study procedures
• Have read and signed the Institutional Review Board (IRB)-approved informed consent form for participating in the study

Exclusion criteria

• Females who are pregnant or nursing

• Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 hours (h) afterwards

• Patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts

• Patients with pulmonary hypertension or unstable cardiopulmonary conditions

• Patients currently on chemotherapy or with other primary cancers requiring systemic or hepatic loco-regional treatment

• Patients who are clinically unstable, patients who are seriously or terminally ill with a life expectancy of less than 1 month, and patients whose clinical course are unpredictable; for example:

  • Patients on life support or in a critical care unit
  • Patients with unstable occlusive disease (e.g., crescendo angina)
  • Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
  • Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] class IV)
  • Patients with recent cerebral hemorrhage
  • Patients who have undergone surgery within 24 hours prior to the study sonographic examination

• Patients with a history of anaphylactic allergy to Definity, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock

• Patients with congenital heart defects

• Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli

• Patients with respiratory distress syndrome

• Patients with thrombosis within the splenic vein

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

contrast-enhanced subharmonic ultrasound imaging

Experimental group

Description:

Patients receive perflutren lipid microspheres IV. After 15 minutes, patients receive perflutren lipid microspheres IV again over 5 minutes and undergo contrast-enhanced subharmonic ultrasound imaging over 60 minutes.

Treatment:

Drug: Perflutren Lipid Microspheres

Procedure: Contrast-Enhanced Subharmonic Ultrasound Imaging