Clinical trials: Non-palpable Breast Lesions
Breast Cancer
"The Efficacy of 'Radioguided Occult Lesion Localization' (ROLL) Versus 'Wire-guided Localization' (WGL) in Breast Conserving Surgery for Non-palpable Breast Cancer: a Randomized Clinical Trial"
Rationale: Approximately 25% of breast cancers detected are non palpable. Accordingly, a localization technique is required to help the surgeon to find and remove the cancer.
- Trial name
- ROLL (NCT00539474)
- Testing
- Radio guided occult lesion localisation
- Where
- 4 sites in Netherlands
- Volunteers
- 316 people
- Sponsor
- UMC Utrecht
Breast Cancer
Comparison of Two Types of Biopsy in Patients With Breast Lesions
RATIONALE: Biopsy is the removal of cells or tissue for examination under a microscope. It is not yet known which type of breast biopsy is more effective for diagnosing breast lesions.
- Trial name
- NCT00006031
- Testing
- Needle localized breast biopsy with specimen x-ray, Low dose radioactive seed followed by surgery and mammogram
- Where
- United States
- Volunteers
- 117 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Breast Diseases
To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions(Phase 3)
This study is a multicenter, Randomized, Open-label, Parallel, Phase 3 Clinical Trial in 8 weeks for screening, once Investigational product injection, Follow up visit.
- Trial name
- NCT04606329
- Testing
- LuminoMark inj.(Conc. for fluorescence), Charcotrace Inj.
- Where
- South Korea
- Volunteers
- 109 people
- Sponsor
- Hanlim Pharm. Co., Ltd.
Breast Neoplasms
Magnetic Occult Lesion Localization and Imaging (MOLLI)
The proposed trial is a non-randomized, single-arm study examining the technical feasibility and safety of magnetic occult lesion localization and imaging (MOLLI) for Breast Conserving Surgery (BCS), in patients with non-palpable…
- Trial name
- MOLLI (NCT03660137)
- Testing
- MOLLI Localization
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Sunnybrook Health Sciences Centre
Breast Cancer
ROLL vs WGLL for Non-palpable Breast Lesions
Here were present a controlled clinical trial comparing wire-guided lesion localization (WGLL)and radioguided occult lesion localization (ROLL) in patients treated for nonpalpable breast lesions at the Instituto Nacional de…
- Trial name
- ROLLvsWGLL (NCT02869230)
- Testing
- ROLL, wire-guided lesion localization
- Volunteers
- 129 people
- Sponsor
- Instituto Nacional de Cancerologia, Columbia
Non-palpable Breast Lesions
Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions
The goal of this investigation is to obtain clinical data to show the Health Beacons Radiofrequency Identification (RFID) Localization System is safe and performs as intended as a localization device for marking and retrieving a…
- Trial name
- NCT01574664
- Testing
- RFID Tag (Health Beacon)
- Where
- 3 sites in United States
- Sponsor
- Health Beacons
Breast Neoplasms
The MONET - Study: MR Mammography of Nonpalpable Breast Tumors
The purpose of this study is to determine whether performing MRI of the breast will improve breast cancer management by reducing the number of biopsies and in case of malignancy allowing one-stage surgical excision of the tumor.
- Trial name
- MONET (NCT00302120)
- Testing
- Contrast-enhanced MR mammography
- Where
- 3 sites in Netherlands
- Volunteers
- 440 people
- Sponsor
- UMC Utrecht
Breast Cancer
MEthods for LOcalization of Different Types of Breast Lesions
In the last decades, the proportion of breast cancer (BC) patients receiving breast-conserving surgery has increased steadily, reaching 70-80% in developed countries.
- Trial name
- MELODY (NCT05559411)
- Where
- Germany
- Volunteers
- 7,416 people
- Sponsor
- European Breast Cancer Research Association of Surgical Trialists
Breast Cancer
Comparison Between ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion by Randomized Clinical Study.
Several localization techniques are now in use for localization of non-palpable breast lesions. Several studies have compared wire guided localization (WGL), which has been for years the gold standard for non-palpable breast…
- Trial name
- SEED02 (NCT05942118)
- Testing
- Breast conservative surgery
- Where
- Italy
- Volunteers
- 262 people
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
Breast Cancer
ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion: Comparison Between Techniques.
Nowadays, Breast Conservative Surgery (BCS) is the standard of care for patients affected by early breast lesions. Screening programmes led to an increase of impalpable breast lesion detection rates.
- Trial name
- SEED01 (NCT05942092)
- Testing
- Breast conserving surgery
- Where
- Italy
- Volunteers
- 1,400 people
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
Breast Cancer Female
Radioguided Occult Lesion Localisation by Indocyanine Green
Breast cancer is the most common cancer in women. It is the main cause of cancer deaths among women. The incidence of non-palpable tumors is estimated at 60%.
- Trial name
- ROLL-1 (NCT03313908)
- Testing
- detection of the tumor lesion
- Where
- France
- Volunteers
- 10 people
- Sponsor
- University Hospital, Montpellier
Breast Diseases, Breast Cancer
Effectiveness and Safety of Preoperative Magnetic Detection of Non-palpable Breast Lesions
Breast cancer is the most common cancer in women and also has the highest death rate. In 2018, 58,500 new cases were diagnosed in metropolitan France. It affects, in 8 out of 10 cases, women aged 50 and over.
- Trial name
- MAGREES (NCT05327218)
- Where
- France
- Volunteers
- 34 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Breast Neoplasm Female
Breast Localization: RFID Tags vs Wire Localization
The RFID trial focuses on breast localization in patients with non-palpable breast cancers. It aims to demonstrate the improvement in patient comfort when using the Radio Frequency Identification (RFID) tag and LOCalizer™ device…
- Trial name
- RFID (NCT04750889)
- Testing
- RFID tags, Wire localization
- Where
- France
- Volunteers
- 80 people
- Sponsor
- Centre Jean Perrin
Breast Cancer
Avidination for RadionuclideTHerapy in Nonpalpable Breast Cancer
This is an interventional, open-label, non comparative phase 2 trial enrolling patients with nonpalpable breast cancer
- Trial name
- ARTHE (NCT06390241)
- Testing
- Avidin-biotin-Dota-90Y
- Where
- Italy
- Volunteers
- 18 people
- Sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Breast Tumor
Radiofrequency Chip for Localization of Non-Palpable Breast Lesions
The purpose of the project is to compare Radiofrequency identification device (RFID) localization technique with the current clinical standard wire localization technique.
- Trial name
- NCT03684408
- Testing
- RFID Localization, Wire Localization, RFID and Wire Localization
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- University of Missouri-Columbia
Breast Diseases
To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions
This study is a multicenter, Open-label, Parallel, Phase 2 Clinical Trial in 6 weeks for screening, once Investigational product injection, Follow up visit.
- Trial name
- NCT03743259
- Testing
- LuminoMark inj. 0.1mL, LuminoMark inj. 0.2mL, Charcotrace Inj.
- Where
- South Korea
- Volunteers
- 44 people
- Sponsor
- Hanlim Pharm. Co., Ltd.
Breast Cancer, Carcinoma in Situ
Localization of Nonpalpable Breast Lesions
Each year the Danish mammography-screening programme identifies a large number of patients with small non-palpable breast cancers or precancerous lesions.
- Trial name
- NCT01901991
- Testing
- Radioactive seed localization (RSL), Wire-guided localization (WGL)
- Where
- Denmark
- Volunteers
- 410 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Oncology, Breast Cancer
Magnetic Seed Localisation for Nonpalpable Breast Lesions
Screening programs and advances in imaging have led to more breast lesions being diagnosed at an impalpable stage. Multiple localisation techniques for nonpalpable breast lesions have been developed during the past decades.
- Trial name
- NCT03988777
- Testing
- Preoperative localisation technique
- Where
- Belgium
- Volunteers
- 192 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
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 Neoplasm
Magnetic Occult Lesion Localization Instrument (MOLLI) Guidance System for Breast Lesion Localization
The proposed trial is a non-randomized, multi-center, sequential arm registry evaluating clinical, and health economic outcomes following treatment with the Magnetic Occult Lesion Localization Instrument (MOLLI), an approved…
- Trial name
- MOLLI (NCT04893421)
- Testing
- MOLLI Localization
- Where
- Canada
- Volunteers
- 41 people
- Sponsor
- Sunnybrook Health Sciences Centre