Clinical trial · Interventional
Photoacoustic Imaging in Diagnosing Changes in Tumors in Participants With Breast Cancer, Sarcoma, Skin Cancer, or Soft Tissue Malignancy and Healthy Volunteers
A Pilot Study of Photoacoustic Imaging (PAI)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Diagnostic issues
Summary
Brief summary (as posted)
This pilot trial studies how well photoacoustic imaging works in diagnosing changes in tumors in participants with breast cancer, sarcoma, skin cancer, or soft tissue malignancy and healthy volunteers. Photoacoustic imaging is a low-risk imaging method that provides information about the oxygenation of tissues using a combination of light and ultrasound techniques. Photoacoustic imaging uses a signal from hemoglobin to provide information on blood flow and oxygen levels, and it may be helpful in determining changes in tumors after chemotherapy or radiation treatment.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Healthy Subject | — | UNRESOLVED | — |
| Malignant Soft Tissue Neoplasm | Malignant Soft Tissue Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Skin Carcinoma | Skin Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photoacoustic Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (photoacoustic imaging)
- description
- Participants undergo PAI on different parts of the body over 20 minutes for up to 5 imaging sessions for 6 months.
- interventionNames
- Procedure: Photoacoustic Imaging
Primary outcomes (1)
- measure
- Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics
- timeFrame
- Up to 6 months
- description
- This will be deemed a success if at least 3 imaging sessions produce a usable image. Usable datasets will be defined as those images with detectable PAI signal with minimal or no artifacts within the region of interest. This analysis will be done in the imaged sample, consisting of enrolled patients who attempt at least one imaging session. Patients who do not attempt at least one imaging session will be replaced.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ALL GROUPS: * No restriction on race or ethnic background. * Subject must understand the investigational nature of the study and sign an independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure. * HEALTHY VOLUNTEERS: * No history of antimicrobial therapy or drug treatment including anti-hypertensive, diuretic, immunosuppressive or anti-depressant drugs in the previous 6-month period. * No history of diabetes. * No history of cancer to the body site to be imaged. * BREAST, SARCOMA, SKIN CANCER, AND SUPERFICIAL MALIGNANCY PATIENTS: * Biopsy-proven aforementioned malignancy. * SURGICAL FLAP PATIENTS: * Need for plastic surgery reconstruction with a free or rotational flap. Exclusion Criteria: * Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Unwilling or unable to follow protocol requirements or provide consent. * Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to undergo imaging procedure.
References
Publications (0)
Data not yet available