Clinical Trials Logo
NCT number NCT02035085
Study type Interventional
Source Johns Hopkins University
Contact Jeff Bulte, PhD
Phone 443-287-0996
Email jwmbulte@mri.jhu.edu
Status Recruiting
Phase Phase 1
Start date September 2016
Completion date December 2017

Clinical Trial Summary

Six female patients (>18 years of age, pre-menopausal) who have had loco-regional (lumpectomy and radiation) therapy for breast carcinoma and have been at least one-year disease free will undergo liposuction, the autologous SVF cell fraction will be isolated and labeled with CS-1000 in the operating room without entering cell culture, which will then be returned to the patient at the site of breast grafting. Patients will receive a pre-screening MRI . Patients will have an MRI scans over a period of 1 month at Johns Hopkins. Follow-up MRIs at 6,12, and 18 months will also be performed. Only at Johns Hopkins with fluorine being done as part of this investigational study. By performing fluorine MRI and quantification of 19F signal, we hypothesize that the engraftment of transplanted cells can be tracked in ways not possible before, using the total fluorine signal as surrogate marker for cell persistence and survival. We expect that a clinically successful outcome (maintenance of breast contour and volume) will be positively correlated with cell survival. The outcome of this study may pave the way for using 19F MRI cell tracking as a new tool for stem cell therapy in a variety of clinical applications.


Clinical Trial Description

n/a


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


See also
Status Clinical Trial Phase
 Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data N/A
 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
 Terminated NCT01649258 - Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy N/A
 Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A
 Active, not recruiting NCT02371174 - Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan. N/A
 Completed NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) Phase 2/Phase 3
 Recruiting NCT01967823 - T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer Phase 2
 Recruiting NCT02739425 - The Efficacy of Sentimag in Detection of Sentinel Node Biopsy N/A
 Not yet recruiting NCT02767661 - Metronomic Capecitabine Plus Aromatase Inhibitor for First Line Treatment in HR(+), Her2(-) Metastatic Breast Cancer Phase 3
 Not yet recruiting NCT03176888 - Health Benefits of HIT for Breast Cancer Patients N/A
 Recruiting NCT02897050 - Trial of Neoadjuvant Docetaxel ± Metronomic Capecitabine/CTX Followed by FEC in Women With Operable Triple Negative Breast Cancer Phase 2
 Recruiting NCT02913729 - Pre- Versus Postoperative Accelerated Partial Breast Irradiation N/A
 Recruiting NCT03080155 - A Study of the 3D MIRA System in Classifying Women at for Likelihood of Breast Cancer N/A
 Recruiting NCT02875626 - Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer N/A
 Recruiting NCT02840344 - Couples-Based Mindfulness for Young Breast Cancer Survivors N/A
 Recruiting NCT02897544 - Integrative Approaches for Cancer Survivorship 2: Project 2 N/A
 Recruiting NCT02689427 - Phase IIB Neoadjuvant Enzalutamide (ZT) Plus Taxol for Androgen Receptor (AR)-Positive Triple-Negative Breast Cancer (AR+ TNBC) Phase 2
 Recruiting NCT02903524 - Doxorubicin Hydrochloride Liposome Injection Combination With Cyclophosphamide vs Pirarubicin Combination With Cyclophosphamide in Patients With Locally Advanced Breast Cancer Phase 4
 Recruiting NCT02934126 - The Development of a Personalized Decision Aid: Perspectives of Patients and Health Care Professionals on Shared Decision Making and Informational Needs on Radiotherapy for Breast Cancer N/A
 Recruiting NCT02897635 - Integrative Approaches For Cancer Survivorship 2: Project 1 N/A