Status:
COMPLETED
A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Tumors
Lead Sponsor:
University of Oklahoma
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
NA
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 tum...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04365413
Start Date
July 22 2020
End Date
December 12 2022
Last Update
December 14 2023
Active Locations (1)
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1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73117