Clinical trials: Breast Imaging
Healthy Volunteers, Breast Cancer
Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of [131I]-SGMIB Anti-HER2 VHH1 in Healthy Volunteers and Breast Cancer Patients
Primary purpose of the clinical study is to evaluate the safety, biodistribution and radiation dosimetry of [131I]-SGMIB Anti-HER2 VHH1 in healthy volunteers and patients with HER2+ breast cancer.
- Trial name
- CAM-VHH1 (NCT02683083)
- Testing
- [131I]-SGMIB Anti-HER2 VHH1
- Where
- Belgium
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Precirix
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 Cancer, Diagnostic Imaging
Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI
The purpose of this study is to look at the efficacy (how does it work) and safety of gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of breast cancer by mammogram (X-ray examination of…
- Trial name
- NCT01067976
- Testing
- Gadobutrol (Gadavist, Gadovist, BAY86-4875)
- Where
- 40 sites in United States, Argentina and 7 more
- Volunteers
- 446 people
- Sponsor
- Bayer
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
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
Pilot Study to Evaluate High Resolution PET Image-Guidance for Sampling of Breast Abnormalities
The purpose of this pilot clinical study is to test a methodology for using high-resolution Positron Emission Tomography (PET) imaging to guide vacuum-assisted core biopsy of breast abnormalities identified on PET.
- Trial name
- PEM-BX (NCT00606931)
- Testing
- Stereo Navigator Accessory to PEM Flex PET Scanner
- Where
- 5 sites in United States
- Volunteers
- 22 people
- Sponsor
- Naviscan PET Systems
Breast Cancer, Head and Neck Squamous Cell Carcinoma
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine…
- Conditions
- Breast Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Prostate Cancer
- Trial name
- NCT03735680
- Testing
- ONM-100
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- OncoNano Medicine, Inc.
Breast Cancer
Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer
Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis.
- Trial name
- NCT01303419
- Testing
- CE-BMRI, DE-CEDM
- Where
- 5 sites in United States, Belgium and 3 more
- Volunteers
- 224 people
- Sponsor
- GE Healthcare
Breast Cancer
Pilot Clinical Evaluation of a Microwave Imaging System for Breast Cancer Detection
The trialed investigational medical imaging device is a low-power microwave breast imaging system for cancer screening purposes. It is an active device which uses non-ionizing radiation.
- Trial name
- NCT05757427
- Testing
- Wavelia #2
- Where
- Ireland
- Volunteers
- 73 people
- Sponsor
- MVG Industries SAS
Breast Cancer
Evaluation of the Efficacy of Digital Breast Tomosynthesis Imaging
The primary objective of this protocol is to collect the 2-dimensional (2D) screening and diagnostic images, and 3-dimensional (3D) Digital Breast Tomosynthesis (DBT) scans from patient mammography examinations acquired on…
- Trial name
- DBT (NCT01373671)
- Testing
- SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM
- Where
- United States
- Volunteers
- 764 people, healthy volunteers welcome
- Sponsor
- Siemens Medical Solutions USA - CSG
Breast Cancer, Prostate Cancer
[68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)
This was a Phase II, multi-center, open label, single dose study in patients with tumor types known to overexpress Gastrin-Releasing Peptide Receptor (GRPR), including breast, prostate, colorectal, Non-Small Cell Lung Cancer…
- Conditions
- Breast Cancer, Prostate Cancer, Colorectal Cancer, Non Small Cell Lung Cancer
- Trial name
- NeoFIND (NCT03724253)
- Testing
- [68Ga]-NeoBOMB1
- Where
- 3 sites in Austria, France
- Volunteers
- 19 people
- Sponsor
- Advanced Accelerator Applications
Breast Cancer
Investigation of Novel Surgical Imaging for Tumor Excision
This is a multi-center, two-arm randomized, blinded pivotal study to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in…
- Trial name
- INSITE (NCT03686215)
- Testing
- Study Device Arm
- Where
- 14 sites in United States
- Volunteers
- 406 people
- Sponsor
- Lumicell, Inc.
Breast Cancer Female
A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post biopsy handling all during the same procedure.
- Trial name
- NCT03300206
- Testing
- Breast Biopsy
- Where
- 7 sites in United States
- Volunteers
- 525 people
- Sponsor
- Hologic, Inc.
Breast Cancer, Doxorubicin Induced Cardiomyopathy
99mTc-rhAnnexin V-128 Imaging and Cardiotoxicity in Patients With Early Breast Cancer
This was a single center, proof-of-concept (PoC), Phase II study. Patients with histologically confirmed early stage (Stage I, II or III) HER-2 negative breast cancer and scheduled to receive doxorubicin-based (neo)adjuvant…
- Trial name
- NCT02677714
- Testing
- 99mTc-rhAnnexin V-128
- Where
- Canada
- Volunteers
- 14 people
- Sponsor
- Advanced Accelerator Applications
Breast Cancer
Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast Magnetic Resonance Imaging (MRI)
The purpose of this study is to look at the efficacy (how does it work) and safety of gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of breast cancer by mammogram (X-ray examination of…
- Trial name
- GEMMA 2 (NCT01104584)
- Testing
- Gadobutrol (Gadavist, Gadovist, BAY86-4875)
- Where
- 48 sites in United States, Argentina and 7 more
- Volunteers
- 460 people
- Sponsor
- Bayer
Solid Tumors, ER/PR Positive Breast Cancer
MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment
This is a Phase I study to understand the biodistribution of MM-398 and to determine the feasibility of using Ferumoxytol as a tumor imaging agent.
- Conditions
- Solid Tumors, ER/PR Positive Breast Cancer, Triple Negative Breast Cancer, Metastatic Breast Cancer With Active Brain Metastasis
- Trial name
- NCT01770353
- Testing
- Ferumoxytol, MM-398
- Where
- 7 sites in United States
- Volunteers
- 45 people
- Sponsor
- Ipsen
Neoplasms, Breast
Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Participants With Breast Cancer
This is an open-label, single-arm pilot study evaluating the antitumor activity and safety of niraparib as neoadjuvant therapy in participants with Human epidermal growth factor receptor 2 (HER2)-negative and breast cancer…
- Trial name
- NCT03329937
- Testing
- Niraparib
- Volunteers
- 21 people
- Sponsor
- Tesaro, Inc.
Breast Cancer, Breast Cyst
Pilot Clinical Study on a Low-power Electromagnetic Wave Breast Imaging Device for Cancer Screening Purposes.
The trialed investigational medical imaging device is a low-power microwave breast imaging system for cancer screening purposes. It is an active device which uses non-ionizing radiation.
- Trial name
- NCT03475992
- Testing
- Low-power microwave breast imaging system
- Where
- Ireland
- Volunteers
- 25 people
- Sponsor
- MVG Industries SAS
Breast Cancer
Define the Optimal Uptake Time of 68Ga-OPS202 When Used as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Newly Diagnosed Breast Cancer
The purpose of this clinical research is to define the optimal uptake time of 68Ga-OPS202 as a PET imaging agent to be used to detect and localize breast cancer somatostatin receptor subtype 2 (SSTR2) positive lesions.
- Trial name
- NCT03697551
- Testing
- Satoreotide trizoxetan
- Where
- Austria
- Volunteers
- 4 people
- Sponsor
- Ipsen
Small Cell Lung Cancer and Breast Cancer
Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga-OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2)
This study consists of two phases. The phase I study is designed to investigate the safety and tolerability of Satoreotide tetraxetan following fractionated i.v.
- Trial name
- SSTR2+ (NCT03773133)
- Testing
- Satoreotide tetraxetan, Satoreotide trizoxetan
- Where
- 8 sites in United States, Austria and 5 more
- Volunteers
- 9 people
- Sponsor
- Ipsen