Post-Mastectomy Surveillance to Detect Recurrence in Breast Cancer Patients

Providence Health & Services

Status: Unknown

Conditions: Breast Cancer

Treatments: Device: post mastectomy ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT02688725

5617S-14

Details and patient eligibility

About

Currently, there is no standard recommendation for using imaging studies to check patients for breast cancer recurrence who have been treated with mastectomy. The investigator proposes performing in-office ultrasound examinations of these patients to determine if this would be helpful in identifying an expected 5-7% of patients with breast cancer recurrences following mastectomy.

Full description

The investigator hypothesizes that surgeon-directed ultrasound is a feasible, accurate, and cost-effective strategy for local recurrence surveillance in breast cancer patients after mastectomy. Toward examining these hypotheses, the investigators propose the following Specific Aims:

Aim I: To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound.

Aim II: To determine the sensitivity and specificity of surgeon-performed ultrasound for the detection of post-mastectomy breast cancer recurrence.

Aim III: To estimate the cost of performing surgeon-directed ultrasound for the detection of post-mastectomy breast cancer recurrence from the perspective of a third party payer relative to standard surveillance alone.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• must be ≥ 18 years of age.
• histologic diagnosis of invasive (ductal or lobular) or in situ (ductal) breast cancer (American Joint Committee on Cancer, 7th edition stage 0, I, II, III, or IV) -previously treated with mastectomy

Exclusion criteria

• pregnant or breast feeding.
• cannot tolerate lying supine for breast ultrasound examination.
• mastectomy for lobular carcinoma in situ, atypical ductal hyperplasia, or extensive microcalcifications in the absence of concurrent DCIS or invasive breast cancer

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Ultrasound

Experimental group

Description:

post mastectomy ultrasound

Treatment:

Device: post mastectomy ultrasound