Breast Cancer Clinical Trial
Official title:
Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer
This is a multi-center, single-arm 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 identifying residual cancer in the lumpectomy bed of female breast
cancer patients undergoing breast in order to assist surgeons in reducing the rates of
positive margins.
In this study, patients will be injected with LUM015 prior to surgery. The study physician
should perform their standard of care lumpectomy, which may include the removal of shaves.
Therapeutic (Lumicell guided) shaves will be removed based on the recommendation of the LUM
Imaging System after the standard of care lumpectomy. Patients will be followed until their
first standard of care post-operative follow-up visit.
For breast cancer lumpectomies, the presence of residual cancer cells left in the tumor bed
after initial resection is inferred by post-operative margin assessment of the resected
tissue by a pathologist.
The injection of the study drug will occur 2-6 hours prior to surgery at a dose of 1.0 mg/kg.
The surgeon will complete the lumpectomy and remove any standard of care shaves if
applicable. The surgeon will use the Lumicell device to look inside the lumpectomy cavity to
see if the dye indicates any areas that may contain residual tumor. If the imaging identifies
that there may be cancer cells remaining in the lumpectomy cavity, the surgeon will remove an
additional piece of tissue. This process will be continued until a negative reading from the
device is obtained or a maximum of 2 shaves of additional tissue has been removed in each
orientation.
Study treatment ends when the surgery is completed. All patients will continue their
enrollment in the study until their first follow-up visit and they will continue to be
followed until the medical team determines no further surgical intervention is required.
Patients with adverse events that are determined to be possibly related to the LUM Imaging
System will be followed until resolution or stabilization of the adverse event.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03095352 -
A Randomized Phase II Study of Pembrolizumab, an Anti-PD (Programmed Cell Death)-1 Antibody, in Combination With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease
|
Phase 2 | |
| Active, not recruiting |
NCT01472094 -
Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults
|
||
| Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
| Active, not recruiting |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
| Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
| Recruiting |
NCT03709134 -
Genomic Markers for Measuring Metastatic Risk in Breast Cancer Following Primary Treatment
|
||
| Recruiting |
NCT03667716 -
COM701 in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT01857193 -
Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer
|
Phase 1 | |
| Recruiting |
NCT01624090 -
Mithramycin for Lung, Esophagus, and Other Chest Cancers
|
Phase 2 | |
| Recruiting |
NCT03432429 -
REI-EXCISE iKnife Study
|
N/A | |
| Active, not recruiting |
NCT02139358 -
Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03615573 -
Survey Study: Financial Impact of Breast Cancer Treatment
|
||
| Completed |
NCT03323333 -
Psychosocial Intervention Pilot for Partners in BRCA Testing
|
N/A | |
| Terminated |
NCT01649258 -
Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy
|
Phase 1 | |
| Recruiting |
NCT03473639 -
A Pilot Study of the Combination of Entinostat With Capecitabine in High Risk Breast Cancer After Neo-adjuvant Therapy
|
Phase 1 | |
| Withdrawn |
NCT03285607 -
MCS110 Combined With Neoadjuvant Doxorubicin, Cyclophosphamide, and Weekly Paclitaxel in Patients With Hormone-Receptor Positive and HER2- Breast Cancer
|
Phase 1 | |
| Not yet recruiting |
NCT03530696 -
T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT03661892 -
Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets
|
Early Phase 1 | |
| Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
| Recruiting |
NCT01992432 -
Brain Functional MRI in Older Women With Breast Cancer (Brain fMRI-BC)
|
