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

A Pilot Study of Photoacoustic Imaging (PAI)

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.

Study Overview

• Status: Terminated
• Conditions: Sarcoma; Breast Carcinoma; Skin Carcinoma; Healthy Subject; Malignant Soft Tissue Neoplasm
• Intervention / Treatment: Procedure: Photoacoustic Imaging

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (photoacoustic imaging); Participants undergo PAI on different parts of the body over 20 minutes for up to 5 imaging sessions for 6 months.	Procedure: Photoacoustic Imaging; Undergo PAI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics	This will be deemed a success if at least 3 imaging sessions produce a usable image. Usable datasets will be defined as those images with detectable PAI signal with minimal or no artifacts within the region of interest. This analysis will be done in the imaged sample, consisting of enrolled patients who attempt at least one imaging session. Patients who do not attempt at least one imaging session will be replaced.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utility of serial PAI measurements	This will be explored by comparison with disease and outcome characteristics collected during routine cancer treatment, including standard imaging modalities, pathology results, and clinical outcomes. Results of these analyses are intended to inform development of early stage (Phase 1/2) clinical trials that consider PAI summaries as biomarkers for treatment response.	Up to 6 months
Serial PAI oxygenation measurements	This will be correlated with disease and patient characteristics using Analysis of Variance (ANOVA ) for categorical factors	Up to 6 months
Serial PAI oxygenation measurements	This will be correlated with disease and patient characteristics using OLS regression for continuous factors	Up to 6 months
Serial PAI oxygenation measurements	This will be correlated with disease and patient characteristics using Cox Regression models for progression and overall survival.	Up to 6 months

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: July 24, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Breast Diseases; Sarcoma; Breast Neoplasms; Carcinoma; Soft Tissue Neoplasms
• Other Study ID Numbers: I 56617 (Other Identifier: Roswell Park Cancer Institute); R01CA204636 (U.S. NIH Grant/Contract); NCI-2018-01424 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No