Breast Cancer Clinical Trial
Official title:
Ex-vivo Performance Evaluation of the Histolog™ Scanner for Human Breast Carcinoma Detection on Fresh Breast Core Biopsies
NCT number | NCT03530722 |
Other study ID # | 2017-00836 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 4, 2017 |
Est. completion date | December 11, 2017 |
Verified date | April 2018 |
Source | Brust-Zentrum AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Fresh breast core biopsies suspicious for breast cancer that are usually taken during
clinical breast assessments will be imaged via confocal microscopy.
The device so called HistologTM Scanner is based on confocal fluorescence and displays
microscopic histology images superficial layers of fresh tissue.
After the imaging procedure the fresh breast tissue specimen will be followed according to
the gold standard workflow (H&E-stained images).
Subsequently, two pathologists will analyze the HistologTM Scanner obtained-images and
H&E-stained images for potential breast cancer structures.
A comparison of both analyses for cancer visualization will be performed to evaluate the
feasibility of using confocal microscopy for breast cancer detection.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 11, 2017 |
Est. primary completion date | November 15, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult female patient =18 years old. - Patient presenting with suspected breast carcinoma. - Patient eligible for biopsy sampling. - Patient must sign a written informed consent prior to research project entry. Exclusion Criteria: - Patient previously treated for breast carcinoma. - Patient has undergone previous neo-adjuvant treatment. - Patient is not willing to participate in the research project. - Patient is not capable of consenting. - Patient is younger than 18 years old - Patient is male |
Country | Name | City | State |
---|---|---|---|
Switzerland | Brust-Zentrum AG | Zürich |
Lead Sponsor | Collaborator |
---|---|
Brust-Zentrum AG |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correspondence of pathologic assessment in specimen suspicious for breast cancer | Evaluate the correspondence of breast cancer diagnosis based on confocal HistologTM Scanner images in comparison with gold standard pathology assessment. | up to 24 weeks | |
Secondary | Usability of the HistologTM Scanner confocal device | Assess the usability of the HistologTM Scanner confocal device in the context of breast surgery by gathering feedback and expert opinion from the medical staff involved in the research study. | up to 24 weeks | |
Secondary | Acceptance of the HistologTM Scanner confocal device | Assess the acceptance of the HistologTM Scanner confocal device in the context of breast surgery by gathering feedback and expert opinion from the medical staff involved in the research study. | up to 24 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Recruiting |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |