Clinical trial · Interventional
Clinical Explorative Optical Breast Investigations
Breast Cancer Diagnosis Using Optical Techniques
NCT06857669CI-TRIAL-00109823CLEO-BrecruitingN/AClinicalTrials.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)
This study evaluates diffuse reflectance spectroscopy and photoacoustic imaging for differentiating healthy, benign, and malignant breast tissue by identifying their optical profiles.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Breast Tumors | Benign Breast Neoplasm | ALIAS | 0.90 |
| Healthy | — | UNRESOLVED | — |
| Malignant Breast Tumours | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diffuse reflectance spectroscopy and Photoacoustic imaging, | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (Diffuse reflectance spectroscopy or Photoacoustic imaging)
- description
- In part I, 30 breast specimens will be examined by DRS (ex-vivo). In part II, 30 breast specimens will be examined by both DRS and PAI (ex-vivo). In part III, 30 individuals will be examined by PAI (in-vivo).
- interventionNames
- Diagnostic Test: Diffuse reflectance spectroscopy and Photoacoustic imaging,
Primary outcomes (1)
- measure
- Number of study subjects with correctly classified breast tissue type with PAI/DRS
- timeFrame
- 30 days
- description
- To evaluate if optical techniques (DRS/PAI) can differentiate between three breast tissue types, namely healthy, benign and malignant tissue. Differences in the optical tissue-properties will be compared to histopathological evaluation.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * solitary malignant or benign biopsy verified tumour \> 1 cm * understands written and oral Swedish Exclusion Criteria: * previous breast surgery * has received neoadjuvant chemotherapy * skin burns in on the chest
References
Publications (1)
- RESULTChaudhry N, Albinsson J, Cinthio M, Kroll S, Malmsjo M, Ryden L, Sheikh R, Reistad N, Zackrisson S. Breast Cancer Diagnosis Using Extended-Wavelength-Diffuse Reflectance Spectroscopy (EW-DRS)-Proof of Concept in Ex Vivo Breast Specimens Using Machine Learning. Diagnostics (Basel). 2023 Sep 28;13(19):3076. doi: 10.3390/diagnostics13193076. PMID 37835819