Clinical trials: Breast-Conserving Surgery
Breast Neoplasm Female, Breast Cancer
Fluorescence Imaging of Carcinoma During Breast Conserving Surgery
Breast conserving surgery (BCS) is performed on patients with breast cancer to resect and completely remove the cancer while conserving as much of the surrounding healthy tissue as possible.
- Trial name
- NCT04815083
- Testing
- Aminolevulinic Acid Hydrochloride, Eagle V1.2 Imaging System
- Where
- 7 sites in United States
- Volunteers
- 57 people
- Sponsor
- SBI ALApharma Canada, Inc.
Breast Cancer
Study the Role of Positron Emission Mammography in Pre-surgical Planning for Breast Cancer
Women with newly diagnosed breast cancer anticipating breast-conserving surgery are enrolled into the study and will undergo both high-resolution positron emission mammographic (PEM) imaging and contrast-enhanced magnetic…
- Trial name
- NCT00484614
- Testing
- Positron Emission Mammography, Magnetic Resonance Imaging
- Where
- 6 sites in United States
- Volunteers
- 472 people
- Sponsor
- Naviscan PET Systems
Breast Neoplasms, Carcinoma, Ductal, Breast
Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy
A post-marketing study evaluating the transplantation of autologous fat augmented with Adipose Derived Regenerative Cells (ADRCs), in patients with functional and cosmetic breast deformities post segmental mastectomy or…
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Mammaplasty, Mastectomy, Segmental, Lumpectomy, Breast Reconstruction,
- Trial name
- RESTORE-2 (NCT00616135)
- Testing
- ADRC-Enhanced Autologous Fat Transplant
- Where
- 5 sites in Belgium, Italy and 2 more
- Volunteers
- 71 people
- Sponsor
- Cytori Therapeutics
Breast Cancer
Intraoperative Use of ClearEdge Device in Breast Conserving Surgery
Multi center, pivotal prospective, randomized clinical trial The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast…
- Trial name
- NCT05456373
- Testing
- ClearEdge device
- Where
- United States
- Volunteers
- 288 people
- Sponsor
- LS BioPath
Breast Cancer, Breast Cancer Invasive
Specimen PET-CT Imaging for Intraoperative Margin Assessment in Breast Cancer
Breast-conserving surgery (BCS) has become the standard-of-care for surgical management of the majority of women with early-stage breast cancer.
- Conditions
- Breast Cancer, Breast Cancer Invasive, Breast Cancer in Situ
- Trial name
- BrIMA (NCT04999917)
- Testing
- high-resolution PET-CT specimen imaging.
- Where
- Belgium
- Volunteers
- 206 people
- Sponsor
- XEOS Medical
Breast Cancer
SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery
This is a multicenter, first-in-human (FIH), open label, Phase 1 dose escalation and recommended Phase 2 dose (RP2D) extension trial with a primary objective to define the RP2D of SRG-514 when administered intraoperatively to…
- Trial name
- NCT06300411
- Testing
- SRG-514
- Where
- 8 sites in United States
- Volunteers
- 25 people
- Sponsor
- SURGE Therapeutics
Breast Cancer
Randomized Study of Combination Chemotherapy With or Without Focused Microwave Thermotherapy Before Surgery in Treating Women With Large Breast Cancer Tumors
The purpose of this randomized Phase III study is to determine whether preoperative focused microwave heat treatment and chemotherapy combined are more effective than preoperative chemotherapy alone in the treatment of large…
- Trial name
- Medifocus301 (NCT01204801)
- Testing
- Focused Microwave Thermotherapy, Chemotherapy (control)
- Where
- 2 sites in United States, Canada
- Volunteers
- 238 people
- Sponsor
- Medifocus, Inc.
Breast Cancer Female
Intraoperative Use of an Optical Coherence Tomography (OCT) Imaging System to Guide Additional Margin Cavity Shaves in Breast Conserving Surgery (BCS)
Female patients undergoing a breast conserving procedure will be consented for the excised breast tissue to be imaged on an investigational OCT-based device.
- Trial name
- NCT04314700
- Testing
- OCT- based investigational imaging device
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Perimeter Medical Imaging
TNBC - Triple-Negative Breast Cancer
Phase 3 Trial of SRG-514 Administered Intraoperatively to Patients Undergoing Breast-Conserving Surgery
This is a Phase 3 trial to compare SRG-514 (active pharmaceutical ingredient [API]: ketorolac) administered intraoperatively to the tumor resection cavity with standard-of-care (SOC) versus SOC alone in participants with clinical…
- Trial name
- NCT07723469
- Testing
- BCS + SRG-514, BCS
- Where
- 3 sites in United States
- Volunteers
- 400 people
- Sponsor
- SURGE Therapeutics
Breast Cancer, Radiation Dermatitis
A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer
The purpose of this study is to evaluate the effects of topical R1 and R2 for prophylaxis of acute radiation dermatitis in patients with breast cancer receiving radiotherapy.
- Conditions
- Breast Cancer, Radiation Dermatitis, Erythema
- Trial name
- NCT01597921
- Where
- Israel
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Water-Jel
Breast Cancer
Safety and Efficacy of Hormone Therapy With Letrozole in Postmenopausal Women With Breast Cancer
The aim of this study is to assess the safety and efficacy of neoadjuvant hormone therapy with letrozole in postmenopausal women with estrogen- and/or progesterone-receptor positive primary breast cancer on tumour regression to…
- Trial name
- NCT00330317
- Testing
- letrozole
- Where
- 20 sites in United Kingdom
- Volunteers
- 300 people
- Sponsor
- Novartis Pharmaceuticals
Breast Surgery, Lymph Node Excision
Safety & Performance of CANOpus PINtuition Surgical Marker Navigation
The goal of this clinical trial is to evaluate the safety and performance of the Canopus Marker in adult breast cancer patients who are scheduled for breast-conserving surgery. The main questions it aims to answer are: 1.
- Trial name
- CANOPIN (NCT06950021)
- Testing
- Magnetic seed
- Where
- Netherlands
- Volunteers
- 35 people
- Sponsor
- Sirius Medical Systems B.V.
Breast Cancer - Ductal Carcinoma in Situ (DCIS), Breast-Conserving Surgery
Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment
This PMPF study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when including the use of the HLS in the context of breast lumpectomy margin assessment.
- Trial name
- SHIELD (NCT05946759)
- Testing
- Histolog Scanner
- Where
- Germany
- Volunteers
- 54 people
- Sponsor
- SamanTree Medical SA
Breast Cancer, Breast-conserving Surgery
Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery
This study aims to assess the safety and clinical accuracy of the SIRA-1000, SIRA® RFA Electrosurgical Device in ablating margins post-lumpectomy in patients undergoing breast conserving surgery for breast cancer.
- Conditions
- Breast Cancer, Breast-conserving Surgery, Breast Cancer - Infiltrating Ductal Carcinoma, ER/PR+Her2neu
- Trial name
- NCT07206121
- Testing
- Radiofrequency ablation alone, Radiofrequency ablation Electrosurgical Device
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Innoblative Designs, Inc.
Breast Cancer
Breast Cancer Detection in Breast Surgical Specimens With the Histolog Scanner, Slide-free Confocal Microscope
Study to assess the capability of physicians (breast surgeons and pathologists) to recognize breast cancer in images of fresh lumpectomies generated with the Histolog Scanner, a recent large field-of-view confocal laser scanning…
- Trial name
- Hibiscuss (NCT04976556)
- Testing
- Histolog Scanner
- Where
- France
- Volunteers
- 181 people
- Sponsor
- SamanTree Medical SA
Breast Cancer
CairnSurgical Breast Cancer Locator (BCL) Post-Market Study
This interventional, post-market, multicenter clinical investigation is designed to evaluate the performance of a custom-made medical device, "the Breast Cancer Locator (BCL)" in Subjects with non-palpable breast cancer, in…
- Trial name
- NCT06461663
- Testing
- Breast Cancer Locator Guided Breast Conserving Surgery
- Where
- 6 sites in Germany, Italy and 1 more
- Volunteers
- 35 people
- Sponsor
- CairnSurgical, Inc.
Breast Neoplasms
The Breast Surgery EnLight and LightPath Imaging System Study
This study will correlate the resection margin status of the breast cancer tumour (WLE specimen), cavity shavings (if any) and breast cavity, and the metastatic status of axillary lymph nodes as determined by EnLight, LightPath…
- Trial name
- NCT02151071
- Testing
- EnLight, LightPath
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Lightpoint Medical Limited
Margin Assessment, Breast Cancer
Spectral Cancer Tissue Recognition - I
This analytical performance study aims to validate the SPCTRone system for use in breast conserving surgery of breast cancer patients.
- Trial name
- SPCTR-I (NCT07459062)
- Where
- 2 sites in Netherlands
- Volunteers
- 100 people
- Sponsor
- SPCTR
Breast Neoplasm
SAVI SCOUT Clinical Evaluation Study
The purpose of this study is to evaluate the performance of the SAVI SCOUT® Surgical Guidance System (SAVI SCOUT). The SAVI SCOUT is a medical device, used to provide real-time guidance during localized excisional biopsy or…
- Trial name
- NCT02370082
- Testing
- Localization of breast lesion
- Volunteers
- 150 people
- Sponsor
- Cianna Medical, Inc.
Breast Cancer
Assessment of Lumpectomy Margins With the Histolog Scanner in Comparison With Intraoperative Imaging Techniques
Study to assess the capability of using the Histolog Scanner, a recent large field-of-view confocal laser scanning medical imaging device for the breast cancer detection in fresh lumpectomy margins.
- Trial name
- Polarhis (NCT05118568)
- Testing
- Histolog Scanner
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- SamanTree Medical SA