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O estudo clínico NCT07492589 (PAUS) para Benign Breast Lesions, Malignant Breast Tumours está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Photo-Acoustic and Ultrasonographic Mammoscope (PAUS) Fase II 180
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O estudo clínico NCT07492589 (PAUS) procura avaliar diagnóstico para Benign Breast Lesions, Malignant Breast Tumours. Este é um estudo intervencionista de Fase II. Seu status atual é: em recrutamento. O estudo começou em 1 de fevereiro de 2026 e pretende incluir 180 participantes. Coordenado por Franciscus Gasthuis & Vlietland (Hospital) e deve ser concluído em 1 de abril de 2028. Essas informações foram atualizadas no ClinicalTrials.gov em 25 de março de 2026.
Resumo
The aim of this study is to evaluate the negative predictive value of the Photo Acoustic Imager 3+ (PAM3+) in the detection of female breast lesions (malignant and benign)in an outpatient setting.
Descrição detalhada
Secondary, the diagnostic accuracy of the PAM3+ in the localization, and sizing breast lesions in relation to BI-RADS score, breast density, and conventional imaging is evaluated. This includes assessing usability, patient satisfaction, safety, and establishing the foundation for a PAM3+ lexicon.
Título oficial
Photo-Acoustic and Ultrasound MammoScope to Detect Breast Lesions: The PAUS Study
Condições médicas
Benign Breast LesionsMalignant Breast TumoursOutros IDs do estudo
- PAUS
- NL-010685
Número NCT
Data de início (real)
2026-02-01
Última atualização postada
2026-03-25
Data de conclusão (estimada)
2028-04-01
Inscrição (estimada)
180
Tipo de estudo
Intervencionista
FASE
Fase II
Status
Em recrutamento
Palavras-chave
Photo-acoustic imaging
PAUS
Fotoakoestiek
PAUS
Fotoakoestiek
Propósito principal
Diagnóstico
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalAll patients All patients included in this study will undergo measurements with the PAM3+ imager. | Photo-Acoustic Mammoscope Imager 3+ Patients will lay in prone position on the PAM3+ with one breast at a time in the aperture of the machine. The breast is supported by a plastic cup that holds the breast in place. The aperture/bowl is filled with water. During the measurement, infrared light will be emitted onto the breast. Infrared light will be absorpted by red blood cells which results in contrast compared to its surroundings and it will cause min...Mostrar mais |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
PAM3+ performance | To evaluate the performance of the PAM3+ system in breast imaging. Performance is defined as the negative predictive value in the detection of breast lesions (malignant and benign). | through study completion, an average of 1 year |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Sensitivity | To determine the sensitivity of the PAM3+ to detect breast lesions | through study completion, an average of 1 year |
Positive predictive value | To determine the positive predictive value of the PAM3+ in the detection of breast lesions | through study completion, an average of 1 year |
Specificity of the PAM3+ | To determine the specificity of the PAM3+ for malignant lesions (e.g. malignant biopsy) | through study completion, an average of 1 year |
Differences in Performance | To identify differences in performance per Breast Imaging-Reporting and Data System (Bi-RADS) scores (2-5). It ranks 2 (benign) to 5 (malignant). A higher score means a higher chance of breast cancer. | through study completion, an average of 1 year |
Accuracy | To investigate the accuracy of the PAM3+ device to assess lesion location and size with regard to breast density. The accuracy of the PAM3+ will be compared to conventional imaging techniques (mammography and ultrasound) Accuracy is defined as right size (\<0.5cm difference is accepted) and location of the tumour. | through study completion, an average of 1 year |
Mammary gland visibility | To determine whether the PAM3+ device can visualize the entire mammary gland, defined as imaging coverage extending from the subcutaneous tissue to the pectoral muscle, with the pectoral muscle visible in the acquired images. | through study completion, an average of 1 year |
Agreement | To assess the agreement between tumor size measurements obtained with the PAM3+ device and those obtained using conventional imaging modalities (mammography and ultrasound) and histopathology, based on the maximum tumor diameter measured in millimeters. | through study completion, an average of 1 year |
Agreement | To assess the agreement between tumor location identified with the PAM3+ device and tumor location determined by conventional imaging modalities and histopathology, defined by breast quadrant and clock-face position relative to the nipple. A difference of \<0.5cm is accepted between all modalities. | through study completion, an average of 1 year |
Patient Satisfaction | To assess patient satisfaction with the PAM3+ measurement using a patient satisfaction questionnaire administered immediately after the procedure, with responses recorded on a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied), where higher scores represent greater satisfaction. | Periprocedural |
System usability score | To assess system usability of the PAM3+ device using the System Usability Scale (SUS) questionnaire administered immediately after the PAM3+ measurement. The SUS consists of 10 items rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Item scores are converted to a total SUS score ranging from 0 to 100, where higher scores indicate better perceived usability. | Periprocedural |
Agreement Between BI-RADS Categories Assigned by Breast Radiologists Using Conventional Imaging vs. PAM3+ 3D Imaging | This outcome measure evaluates the agreement between Breast Imaging Reporting and Data System (BI-RADS) categories (2-5) assigned by a radiologist using conventional imaging and the categories assigned by the PAM3+ technician using PAM3+ 3D imaging. A higher agreement outcome represents better agreement between both scores. | through study completion, an average of 1 year |
Adverse events | To investigate the rate of any adverse events (clavien-dindo) | Periprocedural |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Feminino
- Women
- Age > 18 years
- Referred to the outpatient breast clinic of the Franciscus Vlietland Hospital due to a possible breast lesion
- Patients who are fully competent to give written informed consent
- Sufficient knowledge of the Dutch language to complete a questionnaire
- Currently undergoing chemotherapy
- Discharge from the nipple(s)
- Breast ulcers or -wounds
- Currently suffering from mastitis
- Carrier of a resistant bacterium (e.g. Methicillin-resistant Staphylococcus aureus (MRSA) or Multidrug resistant organisms (MDRO; in Dutch: BRMO)
- Irremovable piercings on/in the breast
- Pregnancy
- Patients whose breasts do not fit in the cup sizes (small breasts can be measured without a cup)
- Currently using medication that increases photo-toxicity of the skin or skin care products that increase photosensitivity (e.g. certain antibiotics: tetracyclines or quinolones, certain antidiuretics
- A history of photosensitive disease (e.g. porphyria, lupus erythematosus)
- Currently undergoing therapy for a photosensitive disease and experiencing photosensitive disease
- Currently undergoing phototherapy
- Patients with a known allergy for PVC
- Patients that are not physically capable of climbing on the examination bed
- Patients that are not physically capable of laying on the examination bed during the measurements
Franciscus Gasthuis & Vlietland (Hospital)Responsável pelo estudo
Linda Riks, Investigador principal, MD, Franciscus Gasthuis & Vlietland (Hospital)
Contato central do estudo
Contato: Linda Riks, MD, 010 - 893 6010, [email protected]
1 Locais do estudo em 1 países
South Holland
Franciscus Vlietland Ziekenhuis, Schiedam, South Holland, 3118 JH, Netherlands
Linda Riks, MD, Contato, 010 - 893 6010, [email protected]
Linda Riks, MD, Subinvestigador
Em recrutamento