Clinical trial · Interventional
Photoacoustic Imaging (PAI) of Suspicious Breast Cancers - A Clinical Feasibility Study
Pilot Photoacoustic Imaging (PAI) of Suspicious Breast Cancers - A Clinical Feasibility Study
NCT01780532CI-TRIAL-00025700withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient resources
Summary
Brief summary (as posted)
After locating the suspicious lesion/mass with standard of care mammography and/or ultrasound, a photoacoustic scan will be performed in the breast where the lesion is located. After the PA scan a biopsy will be performed, if clinically indicated (based on the mammogram and ultrasound only).
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photoacoustic Imaging (PAI) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Photo Acoustic Imaging
- description
- An exploratory, single armed, pilot study designed to evaluate the feasibility of Photo Acoustic Imaging (PAI) in a clinical setting.
- interventionNames
- Procedure: Photoacoustic Imaging (PAI)
Primary outcomes (1)
- measure
- The lesion visibility on PAI, described using a five-level scale: 1. Not visible 2. Barely visible 3. Fair (or moderately visible) 4. Visible 5. Clearly visible.
- timeFrame
- 6 months
Secondary outcomes (1)
- measure
- Measures of hypoxia in the lesion
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a breast lesion/mass found at physical examination, mammography or ultrasound (US), that has not been surgically resected * Patients may have any of the following characteristics: * Taking hormones (e.g., contraceptives, hormone replacement therapy, post-cancer Tamoxifen) * Breast implants * Previous breast biopsy * Previous breast surgery * Previous breast cancer * High risk of breast cancer (e.g., breast cancer susceptibility gene (BRCA) mutations, other gynecologic cancer) * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients who have had primary surgical excision of the suspicious finding * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.