Clinical trials: Breast Imaging
Breast Augmentation
Upright Magnetic Resonance Imaging (MRI) Study - Breast Implant Shell Geometry and Edge Scalloping
The purpose of this study is to determine how different types of breast implants contour to the chest wall.
- Trial name
- NCT01238601
- Volunteers
- 18 people
- Sponsor
- Ideal Implant Incorporated
Breast Cancer Detection, Dense Breast Parenchyma
Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in…
- Conditions
- Breast Cancer Detection, Dense Breast Parenchyma, Benign Breast Findings, Normal Breast Screening
- Trial name
- DMT SV RRS3 (NCT04260620)
- Testing
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Delphinus Medical Technologies, Inc.
Positron-Emission Tomography, Immunomodulation
⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's Lymphoma
To determine the safety and feasibility of 89Zr-Df-IAB22M2C as an immunoPET tracer; determine the best time window and protein dose for imaging; determine the pharmacokinetic (PK) and biodistribution of the probe; and to…
- Conditions
- Positron-Emission Tomography, Immunomodulation, Metastatic Solid Malignancies, Hodgkin Lymphoma
- Trial name
- NCT03107663
- Testing
- ⁸⁹Zr-Df-IAB22M2C Infusion
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- ImaginAb, Inc.
Breast Cancer
The PIONEER-01 Study of the Imagio Breast Imaging System
This is a prospective controlled multi-center study involving gray scale (B-mode) ultrasound vs OA/US (opto-acoustic and gray scale ultrasound) for the visualization of suspicious masses.
- Trial name
- NCT01943916
- Testing
- Imagio OA/US (US and OA/US), Imagio gray scale ultrasound
- Where
- 16 sites in United States
- Volunteers
- 2,105 people
- Sponsor
- Seno Medical Instruments Inc.
Breast Cancer, Lymph Node Mapping
A Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems (SPY-PHI) in the Visualization of Lymphatic Vessels and Identification of Lymph Nodes During Sentinel Lymph Node Biopsy in Subjects With Breast Cancer
This is a prospective, open label, multicenter, non-inferiority within-patient study to determine the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an…
- Conditions
- Breast Cancer, Lymph Node Mapping, Sentinel Lymph Node Biopsy
- Trial name
- FILM-B (NCT03200704)
- Testing
- IC2000 and SPY-PHI, Tc-99m radioactive colloid and Gamma Probe
- Where
- 7 sites in United States, Canada
- Volunteers
- 152 people
- Sponsor
- Novadaq Technologies ULC, now a part of Stryker
Breast Screening
Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device
This is a prospective, multi-center image case collection study to acquire de-identified contrast-enhanced breast images on a mammography device to support continuing software technology development.
- Trial name
- NCT06636539
- Testing
- CEM Software in New Mammography Device
- Where
- 2 sites in United States
- Volunteers
- 75 people
- Sponsor
- Hologic, Inc.
Solid Tumors, High Grade Gliomas
Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of (18F) Injection
Study aimed to assess the reproducibility of PET imaging using AH111585 (18F) Injection. Subjects are evaluable if they undergo 2 administrations of AH111585 (18F) Injection (3 to 8 days apart) and the corresponding PET…
- Conditions
- Solid Tumors, High Grade Gliomas, Lung Cancer, Head and Neck Cancer
- Trial name
- NCT00918281
- Testing
- Fluciclatide Injection
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- GE Healthcare
Magnetic Resonance Imaging
Gadobutrol Magnevist-controlled Body Study
The purpose of the study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the body/extremities regions.
- Trial name
- NCT01050829
- Testing
- Gadobutrol (Gadovist, BAY86-4875), Gadopentetate Dimeglumine (Magnevist, BAY86-4882)
- Where
- 15 sites in China, Japan and 1 more
- Volunteers
- 370 people
- Sponsor
- Bayer
Solid Tumor, Colon Carcinoma
PET-imaging of Two Vartumabs in Patients With Solid Tumors
VARTUTRACE is a first-in-human PET/CT molecular imaging study in patients with solid tumors. This study will investigate the biodistribution and pharmacology of two antibody fragments binding oncofetal Chondroitin Sulfate (CS).
- Conditions
- Solid Tumor, Colon Carcinoma, Rectal Carcinoma, Osteosarcoma
- Trial name
- VARTUTRACE (NCT06645808)
- Testing
- 89Zr-DFO-N-Suc-F8scFv, 89Zr-DFO-N-Suc-C9scFv, PET/CT scan
- Where
- Netherlands
- Volunteers
- 32 people
- Sponsor
- Var2 Pharmaceuticals
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
Metastatic Urothelial Carcinoma, Breast Cancer
Imaging Study in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC
This imaging study aims to assess the feasibility, biodistribution, and dosimetry of the imaging agent in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.
- Conditions
- Metastatic Urothelial Carcinoma, Breast Cancer, TNBC - Triple-Negative Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
- Trial name
- NCT07671092
- Testing
- RYZ211/212
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 40 people
- Sponsor
- RayzeBio, Inc.
Breast Cancer
LightPathTM Imaging System for Ex-vivo Assessment of Margin and Lymph Node Status in Breast Cancer Surgical Specimens
This study is a prospective, cross-sectional observational single centre study to assess the feasibility of intra-operative Cerenkov Luminescence Imaging (CLI) of breast cancer wide local excision (WLE) specimens and dissected…
- Trial name
- NCT02037269
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- Lightpoint Medical Limited
Breast Cancer Female
Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue.
This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology.
- Trial name
- NCT04242277
- Testing
- Investigational WF-OCT device
- Where
- 2 sites in United States
- Volunteers
- 198 people
- Sponsor
- Perimeter Medical Imaging
Breast Cancer
IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO)
Imagio breast imaging system, is an opto-acoustic (OA) imaging system designed to concurrently collect images in conjunction with diagnostic ultrasound ( co-registered OA and B-mode imaging).
- Trial name
- MAESTRO (NCT02364388)
- Testing
- Imagio IUS, Imagio OA/US
- Where
- 5 sites in Netherlands
- Volunteers
- 217 people
- Sponsor
- Seno Medical Instruments Inc.
Breast Cancer Female
Brevera™ Breast Biopsy System Data Collection Study
The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post biopsy handling all during the same procedure.
- Trial name
- NCT03456583
- Testing
- Brevera Breast Biopsy System
- Where
- 6 sites in France, Germany and 4 more
- Volunteers
- 500 people
- Sponsor
- Hologic, Inc.
Breast Imaging, Breast Cancer
Cone Beam CT for Breast Imaging
The objective of this pilot study is to investigate Cone Beam Computed Tomography Imaging (CBCT), with the primary goal, the accumulation of a body of evidence to provide preliminary data for a future extensive clinical trials.
- Trial name
- NCT01880580
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Koning Corporation
Breast Cancer, Breast Neoplasms
Delphinus SoftVue™ ROC Reader Study
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in…
- Trial name
- DMT SV RRS1 (NCT03698942)
- Testing
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Delphinus Medical Technologies, Inc.
Breast Cancer
MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer
RATIONALE: Imaging procedures, such as MRI, may allow the doctor to better detect the tumor. Highly focused ultrasound energy may be able to kill tumor cells by heating the breast tumor cells without affecting the surrounding…
- Trial name
- NCT00008437
- Testing
- high-intensity focused ultrasound ablation
- Where
- 2 sites in United States, Canada
- Sponsor
- InSightec
Breast Neoplasms
Delphinus SoftVue Prospective Case Collection - ARM 2
The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear ring-array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and K142517 for use as both a B-mode ultrasonic…
- Trial name
- SV PCC ARM2 (NCT02977247)
- Testing
- Non-Interventional, Automated Whole Breast Ultrasound
- Where
- 10 sites in United States
- Volunteers
- 1,150 people
- Sponsor
- Delphinus Medical Technologies, Inc.
Breast Neoplasms
MBI and Breast Tomosynthesis Screening Accuracies in Patients With Dense Breast Tissue
Primary: In women with heterogeneous or dense breast tissue (mammographic types 3 and 4), MBI (Molecular Breast Imaging) will detect more breast cancers and have greater sensitivity in detecting breast cancer than breast…
- Trial name
- NCT02013726
- Testing
- MBI Scan: The LumaGEM®, 3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions®
- Volunteers
- healthy volunteers welcome
- Sponsor
- Gamma Medica, Inc.