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Trial record 2 of 42 for:    "Buffalo" AND "Singh"

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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ClinicalTrials.gov Identifier: NCT03630601
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : March 11, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Healthy Subject Malignant Soft Tissue Neoplasm Sarcoma Skin Carcinoma Procedure: Photoacoustic Imaging Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of Photoacoustic Imaging (PAI)
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : March 8, 2023
Estimated Study Completion Date : March 8, 2024


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630601


Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Anurag K. Singh    877-767-9355    Anurag.Singh@roswellpark.org   
Principal Investigator: Anurag K. Singh         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Anurag Singh Roswell Park Cancer Institute

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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT03630601     History of Changes
Other Study ID Numbers: 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 )
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

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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

Additional relevant MeSH terms:
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Carcinoma
Sarcoma
Breast Neoplasms
Soft Tissue Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Breast Diseases
Skin Diseases