Photoacoustic Imaging in Diagnosing Changes in Tumors in Participants With Breast Cancer, Sarcoma, Skin Cancer, or Soft Tissue Malignancy and Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-28

Study Completion Date

2023-03-15

Brief Summary

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This pilot trial studies how well photoacoustic imaging works in diagnosing changes in tumors in participants with breast cancer, sarcoma, skin cancer, or soft tissue malignancy and healthy volunteers. Photoacoustic imaging is a low-risk imaging method that provides information about the oxygenation of tissues using a combination of light and ultrasound techniques. Photoacoustic imaging uses a signal from hemoglobin to provide information on blood flow and oxygen levels, and it may be helpful in determining changes in tumors after chemotherapy or radiation treatment.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To define the feasibility of the current photoacoustic imaging (PAI) technology in various groups of human subjects.

SECONDARY OBJECTIVES:

I. To define the utility of the current PAI on various groups of human subjects.

II. When possible, via means of an existing data review, PAI will be correlated with standard imaging modalities performed on patients as routine part of clinical care or on protocol.

III. When possible, via means of an existing data review, PAI will be compared to pathologic specimens.

IV. When possible, via means of an existing data review, PAI data will be correlated with outcomes of patients to therapies they receive.

OUTLINE:

Participants undergo PAI on different parts of the body over 20 minutes for up to 5 imaging sessions for 6 months.

Conditions

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Breast Carcinoma Healthy Subject Malignant Soft Tissue Neoplasm Sarcoma Skin Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (photoacoustic imaging)

Participants undergo PAI on different parts of the body over 20 minutes for up to 5 imaging sessions for 6 months.

Group Type EXPERIMENTAL

Photoacoustic Imaging

Intervention Type PROCEDURE

Undergo PAI

Interventions

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Photoacoustic Imaging

Undergo PAI

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ALL GROUPS:
* No restriction on race or ethnic background.
* Subject must understand the investigational nature of the study and sign an independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure.
* HEALTHY VOLUNTEERS:
* No history of antimicrobial therapy or drug treatment including anti-hypertensive, diuretic, immunosuppressive or anti-depressant drugs in the previous 6-month period.
* No history of diabetes.
* No history of cancer to the body site to be imaged.
* BREAST, SARCOMA, SKIN CANCER, AND SUPERFICIAL MALIGNANCY PATIENTS:
* Biopsy-proven aforementioned malignancy.
* SURGICAL FLAP PATIENTS:
* Need for plastic surgery reconstruction with a free or rotational flap.

Exclusion Criteria

* Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Unwilling or unable to follow protocol requirements or provide consent.
* Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to undergo imaging procedure.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes