An interventional study of Photoacoustic Imaging in Breast Carcinoma, Healthy Subject and Malignant Soft Tissue Neoplasm, sponsored by Roswell Park Cancer Institute. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-31.
Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Diagnostic
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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 7 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Time frame: Up to 6 months
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.
Time frame: 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
Time frame: Up to 6 months
Serial PAI oxygenation measurements
This will be correlated with disease and patient characteristics using OLS regression for continuous factors
Time frame: 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.
Time frame: Up to 6 months
This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Roswell Park Cancer Institute