Clinical trial NCT03297112: Contrast-Enhanced Subharmonic Ultrasound Imaging in Improving Characterization of Adnexal Masses in Patients Undergoing Surgery
Official title: Subharmonic Contrast Ultrasound for Improved Characterization for Adnexal Masses-A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Adnexal Mass
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Lantheus Medical Imaging
First posted: 2017-09-29
Enrollment: 12
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Accuracy of Subharmonic Ultrasound Imaging Compared to Standard Ultrasound or Contrast Enhanced Magnetic Resonance Imaging (MRI)
timeFrame: Baseline scan to day of surgery
measure: Accuracy of SHI Characterization Compared to the Risk of Malignancy Index
timeFrame: Baseline scan to day of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Flemming Forsberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: