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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03630601
Recruitment Status : Suspended (Suspended Temporarily due to COVID-19)
First Posted : August 15, 2018
Last Update Posted : May 8, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Tracking Information
First Submitted Date  ICMJE July 24, 2018
First Posted Date  ICMJE August 15, 2018
Last Update Posted Date May 8, 2020
Actual Study Start Date  ICMJE June 18, 2018
Estimated Primary Completion Date March 8, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics [ Time Frame: Up to 6 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
  • Utility of serial PAI measurements [ Time Frame: Up to 6 months ]
    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 [ Time Frame: Up to 6 months ]
    This will be correlated with disease and patient characteristics using Analysis of Variance (ANOVA ) for categorical factors
  • Serial PAI oxygenation measurements [ Time Frame: Up to 6 months ]
    This will be correlated with disease and patient characteristics using OLS regression for continuous factors
  • Serial PAI oxygenation measurements [ Time Frame: Up to 6 months ]
    This will be correlated with disease and patient characteristics using Cox Regression models for progression and overall survival.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photoacoustic Imaging in Diagnosing Changes in Tumors in Participants With Breast Cancer, Sarcoma, Skin Cancer, or Soft Tissue Malignancy and Healthy Volunteers
Official Title  ICMJE A Pilot Study of Photoacoustic Imaging (PAI)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Breast Carcinoma
  • Healthy Subject
  • Malignant Soft Tissue Neoplasm
  • Sarcoma
  • Skin Carcinoma
Intervention  ICMJE Procedure: Photoacoustic Imaging
Undergo PAI
Study Arms  ICMJE 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.
Intervention: Procedure: Photoacoustic Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: November 12, 2018)
90
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2018)
160
Estimated Study Completion Date  ICMJE March 8, 2028
Estimated Primary Completion Date March 8, 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ALL GROUPS:
  • No restriction on race or ethnic background.
  • Subject or legal representative 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03630601
Other Study ID Numbers  ICMJE I 56617
NCI-2018-01424 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 56617 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
R01CA204636 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Anurag Singh Roswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP