Clinical trial · Interventional
A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Tumors
A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Solid Tumors and Lymph Nodes (MSOT)
NCT04365413CI-TRIAL-00072269OU-SCC-MSOTcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MSOT Device | Device | — | UNRESOLVED |
| Temperature Measurement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imaging of Tumor or Lymph node
- description
- 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.
- interventionNames
- Device: MSOT Device
- Procedure: Temperature Measurement
Primary outcomes (2)
- measure
- Number of Participants With Adverse Events Due to MSOT Imaging
- timeFrame
- 1-2 minutes
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMcNally 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. PMID 40967760