Solid TumorOU-SCC-MSOTNCT04365413
A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Tumors
A study testing MSOT Device and Temperature Measurement in people with Solid Tumor, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- MSOT Device and Temperature Measurement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2020to 12 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117
About this study
Official title: A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Solid Tumors and Lymph Nodes (MSOT)
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.
Read the 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.
- Conditions
- Solid Tumor
- Being tested
- MSOT Device, Temperature Measurement
- Keywords
- Imaging device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSOT DeviceDevice
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.
Temperature MeasurementProcedure or surgery
The temperature of the skin will be measured prior to and after MSOT imaging.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MSOT Device; Procedure: Temperature Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-2 minutes after imaging
Secondary outcomes (3)
Tumor Positivity Based on Detection of Oxy-hemoglobin Using MSOT Device.
MSOT device can identify and differentiate between tumor tissue and surrounding tissue due to detection of different oxygenation states of hemoglobin, with the idea that tumors have differential tissue oxygenation levels compared to non-tumor (control) values. Tumor positivity will be determined based on comparison of oxy-hemoglobin levels using MSOT localization from the same size polygon region of interest (ROI) analysis of the tumor tissue and a sample of non-cancer tissue from the same patient. Increased intensity of signal (output obtained in MSOT Arbitrary Units (MSOT A.U.)) indicates higher levels of oxy-hemoglobin which correlates with tumor tissue as confirmed by comparison with pathology reports. Paired t-tests will be performed and median difference and IQR reported.
Measured: 6 months
Tumor Positivity Based on Detection of Deoxy-hemoglobin Using MSOT
MSOT device can identify and differentiate between tumor tissue and surrounding tissue due to detection of different oxygenation states of hemoglobin, with the idea that tumors have differential tissue oxygenation levels compared to non-tumor (control) values. Tumor positivity will be determined based on comparison of deoxy-hemoglobin levels using MSOT localization from the same size polygon region of interest (ROI) analysis of the tumor tissue and a sample of non-cancer tissue from the same patient. Increased intensity of signal (output obtained in MSOT Arbitrary Units (MSOT A.U.)) indicates higher levels of deoxy-hemoglobin which correlates with tumor tissue as confirmed by comparison with pathology reports. Paired t-tests will be performed and median difference and IQR is reported.
Measured: 6 months
Tumor Positivity From Pathology Reports Compared to MSOT Readings
Tumor positivity will be compared (yes/no) from the standard pathology report with the MSOT readings. Percent of patients with matching readings will be calculated and reported.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start22 Jul 2020
- Primary completion12 Jul 2021
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lacey McNally, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365413
- Sponsor's protocol ID
- OU-SCC-MSOT
- Acronym
- OU-SCC-MSOT
- Status last verified
- Dec 2023
- First submitted
- 23 Apr 2020
- Last updated
- 14 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
McNally LR, Claros-Sorto JC, Bynum RC, Grizzle WE, Han Z, Squires R, Tippetts JD, Brannen A, Garwe T, Cohoon A, Edil BH, Holter-Chakrabarty J, Jain A. Assessment of Breast Tumors Using Multispectral Optoacoustic Tomography in a Surgical Setting. J Nucl Med. 2025 Oct 1;66(10):1597-1604. doi: 10.2967/jnumed.125.269852.
PubMed 40967760
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Solid Tumors and Lymph Nodes (MSOT)
- ClinicalTrials.gov ID
- NCT04365413
- Acronym / sponsor ID
- OU-SCC-MSOT / OU-SCC-MSOT
- Conditions
- Solid Tumor
- Keywords
- Imaging device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 12 Jul 2021 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Posted 2 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging of Tumor or Lymph node | Experimental | Device: MSOT Device, Procedure: Temperature MeasurementTumors 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Patients with central nervous system tumors
- Patients with a tattoo over the surgical site
- Pregnant women
- Women who are breastfeeding
- Systemic or local infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSOT DeviceThe 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. | Device | Imaging of Tumor or Lymph node |
| Temperature MeasurementThe temperature of the skin will be measured prior to and after MSOT imaging. | Procedure or surgery | Imaging of Tumor or Lymph node |
Primary outcome
Number of Participants With Adverse Events Due to MSOT Imaging
Time frame: 1-2 minutes
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.
Evaluate Skin Temperature Pre and Post Imaging (Pre- and Post- Surgery)
Time frame: 1-2 minutes after imaging
Percent of patients who experienced skin temperature readings >44 degrees Celsius.
3 secondary outcomes
Tumor Positivity Based on Detection of Oxy-hemoglobin Using MSOT Device.
Time frame: 6 months
Tumor Positivity Based on Detection of Deoxy-hemoglobin Using MSOT
Time frame: 6 months
Tumor Positivity From Pathology Reports Compared to MSOT Readings
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40967760McNally LR, Claros-Sorto JC, Bynum RC, Grizzle WE, Han Z, Squires R, Tippetts JD, Brannen A, Garwe T, Cohoon A, Edil BH, Holter-Chakrabarty J, Jain A. Assessment of Breast Tumors Using Multispectral Optoacoustic Tomography in a Surgical Setting. J Nucl Med. 2025 Oct 1;66(10):1597-1604. doi: 10.2967/jnumed.125.269852.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lacey McNally, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSOT Device and Temperature Measurement in people with Solid Tumor, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events Due to MSOT Imaging (time frame: 1-2 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04365413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.