Health TrialsbyHealthPanel

Clinical Explorative Optical Breast Investigations

ConditionsBenign Breast TumorsMalignant Breast TumoursHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRegion Skane

About this trial

This study evaluates diffuse reflectance spectroscopy and photoacoustic imaging for differentiating healthy, benign, and malignant breast tissue by identifying their optical profiles.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

solitary malignant or benign biopsy verified tumour > 1 cm

understands written and oral Swedish

Disqualifiers

previous breast surgery

has received neoadjuvant chemotherapy

skin burns in on the chest

Trial design

Design model

Single group

Treatments tested in this trial

  • Diffuse reflectance spectroscopy and Photoacoustic imaging,

    Diagnostic test

    The photoacoustic imaging/diffuse reflectance spectroscopy techniques used in this study have a broader wavelength spectrum. The photoacoustic set-up can generate an optical and an ultrasound image simultaneously.

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Diagnostic (Diffuse reflectance spectroscopy or Photoacoustic imaging)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of study subjects with correctly classified breast tissue type with PAI/DRS

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.

Time frame
30 days

Secondary outcomes

1

Optical signal in relation to photoacoustic imaging depth

Signal intensity will be measured at 5 mm intervals; from skin surface to a depth of approximately 35 mm.

Time frame
2 days
2

To assess oxygenation levels across three breast tissue types using PAI

The percentage of oxygenation within a region of interest (ROI)

Time frame
Immediately after photoacoustic imaging acquisition

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Skane

Lead sponsor

Lund University

Collaborator

Unilabs

Collaborator

Source ClinicalTrials.gov
Apply now