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

Primary Purpose

Breast Carcinoma, Healthy Subject, Malignant Soft Tissue Neoplasm

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Photoacoustic Imaging
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (photoacoustic imaging)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Serial PAI oxygenation measurements
This will be correlated with disease and patient characteristics using Analysis of Variance (ANOVA ) for categorical factors
Serial PAI oxygenation measurements
This will be correlated with disease and patient characteristics using OLS regression for continuous factors
Serial PAI oxygenation measurements
This will be correlated with disease and patient characteristics using Cox Regression models for progression and overall survival.

Full Information

First Posted
July 24, 2018
Last Updated
March 29, 2023
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03630601
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Diagnostic issues
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Healthy Subject, Malignant Soft Tissue Neoplasm, Sarcoma, Skin Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (photoacoustic imaging)
Arm Type
Experimental
Arm Description
Participants undergo PAI on different parts of the body over 20 minutes for up to 5 imaging sessions for 6 months.
Intervention Type
Procedure
Intervention Name(s)
Photoacoustic Imaging
Intervention Description
Undergo PAI
Primary Outcome Measure Information:
Title
Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics
Description
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.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Utility of serial PAI measurements
Description
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.
Time Frame
Up to 6 months
Title
Serial PAI oxygenation measurements
Description
This will be correlated with disease and patient characteristics using Analysis of Variance (ANOVA ) for categorical factors
Time Frame
Up to 6 months
Title
Serial PAI oxygenation measurements
Description
This will be correlated with disease and patient characteristics using OLS regression for continuous factors
Time Frame
Up to 6 months
Title
Serial PAI oxygenation measurements
Description
This will be correlated with disease and patient characteristics using Cox Regression models for progression and overall survival.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anurag Singh
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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