Clinical Explorative Optical Breast Investigations

NCT06857669 | Recruiting DMC

• 1 other identifier: Dnr 2019-04840
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Benign Breast Tumors; Healthy; Malignant Breast Tumours

Keywords

breast; optical imaging; photoacoustic; spectroscopy

Outcome Measures

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.

  30 days

Secondary Outcomes (2)

• Optical signal in relation to photoacoustic imaging depth

  2 days

• To assess oxygenation levels across three breast tissue types using PAI

  Immediately after photoacoustic imaging acquisition

Study Arms (1)

Diagnostic (Diffuse reflectance spectroscopy or Photoacoustic imaging)

EXPERIMENTAL

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).

Diagnostic Test: Diffuse reflectance spectroscopy and Photoacoustic imaging,

Interventions

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.

Diagnostic (Diffuse reflectance spectroscopy or Photoacoustic imaging)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• solitary malignant or benign biopsy verified tumour \> 1 cm
• understands written and oral Swedish

You may not qualify if:

• previous breast surgery
• has received neoadjuvant chemotherapy
• skin burns in on the chest

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator
• Unilabs: collaborator

Study Sites (1)

Skane University Hospital

Malmo, 20502, Sweden

RECRUITING

Related Publications (1)

• Chaudhry 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 RESULT

Related Links

• photoacoustic center at Lund University

Study Officials

• Sophia Zackrisson, MD, PhD

  Region Skane, Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia Zackrisson, MD, PhD

CONTACT

+46 40 33 87 97; sophia.zackrisson@med.lu.se

Nadia Chaudhry, MD

CONTACT

nadia.chaudhry@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: March 4, 2025
• Study Start: December 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)