N/A
N=45
A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Tumors
Solid Tumor
Bottom Line
View on ClinicalTrials.gov: NCT04365413 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Number of Participants With Adverse Events Due to MSOT Imaging — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MSOT Device (Device); Temperature Measurement (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Oklahoma
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events Due to MSOT Imaging |
— | — |
| PRIMARY Evaluate Skin Temperature Pre and Post Imaging (Pre- and Post- Surgery) |
— | — |
| SECONDARY Tumor Positivity Based on Detection of Oxy-hemoglobin Using MSOT Device. |
0.0687 | <0.0001 sig |
| SECONDARY Tumor Positivity Based on Detection of Deoxy-hemoglobin Using MSOT |
0.0420 | <0.0001 sig |
| SECONDARY Tumor Positivity From Pathology Reports Compared to MSOT Readings |
100 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04365413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.