Clinical trial NCT04365413: A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Tumors
Official title: A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Solid Tumors and Lymph Nodes (MSOT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Tumor
Keywords: Imaging device
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the safety and potential of a new experimental imaging instrument called multispectral optoacoustic tomography (MSOT) to detect tumors and lymph nodes with tumors.

Detailed description: This study will involve patients that are scheduled for routine standard of care surgery. It is a single-arm study designed to provide safety information regarding the use of the Acuity MSOT device in the clinical setting, and the ability of MSOT imaging data to correlate with clinical findings identified via pathology.

The device will be used to obtain images of the tumor or lymph node margins for investigational use only to compare to clinical pathology and patient's medical record. All images will be obtained pre- and post-surgery in a closed surgical patient. The temperature of the patient's skin will also be measured prior to and after MSOT imaging. MSOT imaging will be for research only and no treatment decisions will be based on the MSOT images obtained.

Eligibility criteria: Inclusion Criteria:

* Patients with an identified solid tumor, i.e. breast (Stage I-IV), melanoma (Stage I-IV), HNSCC (Stage I-III), pancreatic (Stage I-III), ovarian (Stage I-IV) that is scheduled for surgical removal of the tumor and completed standard imaging prior to surgery
* Have acceptable hematologic status \[total hemoglobin (tHb) ≥ 10 mg/dL\]
* Patients ≥ 18 yrs of age
* Patient provided a signed and dated informed consent
* Willing to comply with study procedures and be available for the duration of the study
* Ability to understand and the willingness to sign an IRB-approved informed consent document.

Exclusion Criteria:

* Patients with central nervous system tumors
* Patients with a tattoo over the surgical site
* Pregnant women
* Women who are breastfeeding
* Systemic or local infection
* Any systemic anomaly during the pre-op assessment preventing patient participation in the study
* Any febrile illness that precludes or delays participation preoperatively
* Anything that would put the participant at increased risk or preclude compliance with the study
* Patients with Stage IV pancreatic cancer, Stage IV HNSCC are not surgical candidates and therefore excluded from this study

Primary outcomes:
measure: Number of Participants With Adverse Events Due to MSOT Imaging
timeFrame: 1-2 minutes
measure: Evaluate Skin Temperature Pre and Post Imaging (Pre- and Post- Surgery)
timeFrame: 1-2 minutes after imaging
Secondary outcomes:
measure: Tumor Positivity Based on Detection of Oxy-hemoglobin Using MSOT Device.
timeFrame: 6 months
measure: Tumor Positivity Based on Detection of Deoxy-hemoglobin Using MSOT
timeFrame: 6 months
measure: Tumor Positivity From Pathology Reports Compared to MSOT Readings
timeFrame: 6 months
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Lacey McNally, PhD
role: PRINCIPAL_INVESTIGATOR
References: