A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Tumors

NCT04365413 | Completed Results DMC FDA Device

• 1 other identifier: OU-SCC-MSOT
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Keywords

Imaging device

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events Due to MSOT Imaging

  Adverse events as characterized by CTCAE v5.0 in patients that may result from MSOT imaging (≥44 degrees Celsius). Measurement of skin temperature pre- and post-MSOT imaging (2 measurements total) with a touch thermometer as part of the safety evaluation of the MSOT device. The thermometer will be placed onto the skin until a temperature appears, about 1 minute, and the temperature will be recorded.

  1-2 minutes

• Evaluate Skin Temperature Pre and Post Imaging (Pre- and Post- Surgery)

  Percent of patients who experienced skin temperature readings \>44 degrees Celsius.

  1-2 minutes after imaging

Secondary Outcomes (3)

• Tumor Positivity Based on Detection of Oxy-hemoglobin Using MSOT Device.

  6 months

• Tumor Positivity Based on Detection of Deoxy-hemoglobin Using MSOT

  6 months

• Tumor Positivity From Pathology Reports Compared to MSOT Readings

  6 months

Study Arms (1)

Imaging of Tumor or Lymph node

EXPERIMENTAL

Tumors and/or lymph nodes of patients scheduled for standard of care surgery will be imaged using the MSOT device before and after surgery. The temperature of their skin prior to and after MSOT imaging will also be measured.

Device: MSOT Device; Procedure: Temperature Measurement

Interventions

MSOT Device DEVICE

The MSOT Device will be used to take images of the tumor and/or lymph nodes of patients with solid tumors before and after surgery to measure the margins of the tumor and/or positive lymph node.

Imaging of Tumor or Lymph node

Temperature Measurement PROCEDURE

The temperature of the skin will be measured prior to and after MSOT imaging.

Imaging of Tumor or Lymph node

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

Location

Results Point of Contact

• Title: Lacey McNally
• Organization: University of Oklahoma Health Sciences Center, Stephenson Cancer Center

lacey-mcnally@ouhsc.edu

405-325-0789

Study Officials

• Lacey McNally, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 28, 2020
• Study Start: July 22, 2020
• Primary Completion: July 12, 2021
• Study Completion: December 12, 2022
• Last Updated: December 14, 2023
• Results First Posted: November 2, 2022

Record last verified: 2023-12

Locations

US (1)