Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT06857669
Status:
RECRUITING
Last Update Posted:
2025-03-10
First Post:
2025-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Explorative Optical Breast Investigations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2025-01-07', 'studyFirstSubmitQcDate': '2025-02-27', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}], 'secondaryOutcomes': [{'measure': 'Optical signal in relation to photoacoustic imaging depth', 'timeFrame': '2 days', 'description': 'Signal intensity will be measured at 5 mm intervals; from skin surface to a depth of approximately 35 mm.'}, {'measure': 'To assess oxygenation levels across three breast tissue types using PAI', 'timeFrame': 'Immediately after photoacoustic imaging acquisition', 'description': 'The percentage of oxygenation within a region of interest (ROI)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast', 'optical imaging', 'photoacoustic', 'spectroscopy'], 'conditions': ['Benign Breast Tumors', 'Malignant Breast Tumours', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '37835819', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.photoacoustics.lu.se/lund-university-photoacoustic-center', 'label': 'photoacoustic center at Lund University'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates diffuse reflectance spectroscopy and photoacoustic imaging for differentiating healthy, benign, and malignant breast tissue by identifying their optical profiles.', 'detailedDescription': 'Breast cancer is the most prevalent cancers among women worldwide. Current diagnostic modalities have notable limitations. Mammography exposes patients to harmful ionising radiation whilst MRI often requires intravenous contrast agents. Additionally, diagnosing breast cancer frequently relies on invasive biopsies, which can cause patient discomfort.\n\nThis study investigates the potential use of two optical modalities, diffuse reflectance spectroscopy (DRS) and photoacoustic imaging (PAI), as non-invasive diagnostic tools for breast tissue analysis. Advantages include use of non-ionising radiation, contrast-free imaging, and the ability to assess tissue properties in detail.\n\nDRS is a non-image based hand-held modality that utilises white light to generate optical signals. PAI is a hybrid biomedical imaging modality that combines traditional ultrasound with optical imaging. The latter generates a functional image that can potentially assess oxygenation levels which is known to be different in healthy vs cancerous tissue.\n\nThe study will focus on analysing three types of human breast tissues: healthy tissue, benign lesions (such as fibroadenomas), and malignant lesions (invasive breast carcinomas). By identifying the unique optical signatures of each tissue type, the research aims to evaluate the feasibility of these optical techniques as complementary tool to traditional imaging methods for diagnosing or monitoring breast cancer in the future.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* solitary malignant or benign biopsy verified tumour \\> 1 cm\n* understands written and oral Swedish\n\nExclusion Criteria:\n\n* previous breast surgery\n* has received neoadjuvant chemotherapy\n* skin burns in on the chest'}, 'identificationModule': {'nctId': 'NCT06857669', 'acronym': 'CLEO-B', 'briefTitle': 'Clinical Explorative Optical Breast Investigations', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Breast Cancer Diagnosis Using Optical Techniques', 'orgStudyIdInfo': {'id': 'Dnr 2019-04840'}}, 'armsInterventionsModule': {'armGroups': [{'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,']}], 'interventions': [{'name': 'Diffuse reflectance spectroscopy and Photoacoustic imaging,', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Diagnostic (Diffuse reflectance spectroscopy or Photoacoustic imaging)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20502', 'city': 'Malmo', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Sophia Zackrisson, MD, PhD', 'role': 'CONTACT', 'email': 'sophia.zackrisson@med.lu.se', 'phone': '+46 40 33 87 97'}, {'name': 'Nadia Chaudhry, MD', 'role': 'CONTACT', 'email': 'nadia.chaudhry@med.lu.se'}], 'facility': 'Skane University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'centralContacts': [{'name': 'Sophia Zackrisson, MD, PhD', 'role': 'CONTACT', 'email': 'sophia.zackrisson@med.lu.se', 'phone': '+46 40 33 87 97'}, {'name': 'Nadia Chaudhry, MD', 'role': 'CONTACT', 'email': 'nadia.chaudhry@med.lu.se'}], 'overallOfficials': [{'name': 'Sophia Zackrisson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Region Skane, Lund University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data used in this study contains sensitive information about the study participants and they did not provide consent for public data sharing. A minimal data set could, however, be shared by request from a qualified academic investigator for the sole purpose of replicating the present study, provided the data transfer is in agreement with EU legislation on the general data protection regulation and approval by the Swedish Ethical Review Authority.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lund University', 'class': 'OTHER'}, {'name': 'Unilabs', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}