Clinical trial NCT03630601: Photoacoustic Imaging in Diagnosing Changes in Tumors in Participants With Breast Cancer, Sarcoma, Skin Cancer, or Soft Tissue Malignancy and Healthy Volunteers
Official title: A Pilot Study of Photoacoustic Imaging (PAI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Carcinoma
Healthy Subject
Malignant Soft Tissue Neoplasm
Sarcoma
Skin Carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-08-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics
timeFrame: Up to 6 months
Secondary outcomes:
measure: Utility of serial PAI measurements
timeFrame: Up to 6 months
measure: Serial PAI oxygenation measurements
timeFrame: Up to 6 months
measure: Serial PAI oxygenation measurements
timeFrame: Up to 6 months
measure: Serial PAI oxygenation measurements
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Anurag Singh
role: PRINCIPAL_INVESTIGATOR
References: