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

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Roswell Park Comprehensive Cancer Center

Status

Terminated

Conditions

Malignant Soft Tissue Neoplasm
Healthy Subject
Sarcoma
Skin Carcinoma
Breast Carcinoma

Treatments

Procedure: Photoacoustic Imaging

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03630601
NCI-2018-01424 (Registry Identifier)
I 56617 (Other Identifier)
R01CA204636 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 1 patient group

Diagnostic (photoacoustic imaging)
Experimental group
Description:
Participants undergo PAI on different parts of the body over 20 minutes for up to 5 imaging sessions for 6 months.
Treatment:
Procedure: Photoacoustic Imaging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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