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

Sarcoma Clinical Trial

Official title:

A Pilot Study of Photoacoustic Imaging (PAI)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03630601
• Other study ID #: I 56617
• Secondary ID: NCI-2018-01424I
• Status: Terminated
• Phase: N/A
• Start date: June 28, 2018
• Est. completion date: March 15, 2023

Study information

• Verified date: March 2023
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Healthy Subject
• Malignant Soft Tissue Neoplasm
• Sarcoma
• Skin Carcinoma
• Soft Tissue Neoplasms

Intervention

Procedure:
• Photoacoustic Imaging
Undergo PAI

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Serial PAI oxygenation measurements	This will be correlated with disease and patient characteristics using OLS regression for continuous factors	Up to 6 months
Secondary	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