Contrast Ultrasound Detection of Sentinel Lymph Nodes

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a two part, open label, non-randomized trial of women with a breast cancer diagnosis scheduled for excisional surgery and sentinel lymph node (SLN) evaluation.

Part 1 is a two-period, crossover, dose-finding study, which will be performed in 12 healthy female volunteers to determine the optimal dose as well as the safety and tolerability of the tissue-specific, contrast agent Sonazoid (GE Healthcare, Oslo, Norway) for human lymphatic applications. In Part 2 lymphosonographic SLN identification will be compared to that of isotope mapping during surgery on 90 female, breast cancer patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University; Thomas Jefferson University
• Collaborators: GE Healthcare; National Cancer Institute (NCI); Siemens Medical Solutions

Criteria

Inclusion Criteria:

• Part 1:

• Be female.

• Be at least 21 years of age.

• Must have a body mass index (BMI) greater or equal to 19 and less than or equal to 33.

• Be able to comprehend the full nature, purpose and risks of the study.

• Part 2:

• Be female.

• Be diagnosed with breast cancer.

• Be scheduled for a surgical excision with SLN evaluation.

• Be at least 21 years of age.

• Be medically stable.

• If of child-bearing potential, must have a negative pregnancy test.

• Be able to comply with study procedures.

• Have read and signed the IRB-approved Informed Consent form for participating in the study.

Exclusion Criteria:

• Part 1:

• A history of chest wall trauma or surgery, or dermatologic disorders, which could be expected to disrupt lymphatic drainage of the chest wall.

• A history of surgical breast augmentation, reduction, or biopsy.

• Lymphedema or chronic edema.

• Females who are pregnant or nursing or are actively lactating.

• Exposure to ultrasound contrast agents in the 1 month prior to study initiation.

• Known hypersensitivity to ultrasound contrast agents.

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

• Significant axillary, supraclavicular, or other chest wall palpable adenopathy.

• Evidence of current ongoing illicit drug use or average alcohol use of greater than 2 drinks a day.

• Use of more than 5 cigarettes/day.

• Participation in an investigational drug study within the period starting 1 month before study drug administration.

• Subject is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder within the last 5 years. Subjects who have had situational depression may be enrolled in the study at the discretion of the Investigator.

• Subject has a history of any illness that, in the opinion of the study Investigator, might confound the results of the study or poses an additional risk to the subject by his participation in the study.

• An estimated creatinine clearance of ≤80 ml/min based on the Cockcroft-Gault equation. An actual creatinine clearance, as determined by a 24 hour urine collection, may be used in place of the Cockcroft-Gault equation. Subjects who have an actual or estimated creatinine clearance 70 ml/min may be enrolled at the discretion of the investigator.

• A history of neoplastic disease, with the exception of non-melanoma skin cancer.

• Any other condition precluding subject participation as per investigator judgment.

• Part 2:

• Females who are pregnant or nursing.

• Patients who have had prior breast reduction.

• Patients with a prior axillary procedure on the side scheduled for SLN evaluation.

• Patients with other primary cancers requiring systemic treatment.

• Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is 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 (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 eggs or egg products, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock. (Subjects with nonanaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 h following the administration of Sonazoid).

• Patients with cardiac shunts or unstable cardiopulmonary conditions.

• Patients with congenital heart defects.

• Patients with severe 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

• Patients with respiratory distress syndrome.