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Trial record 9 of 19 for:    breast cancer AND premenopausal | Open Studies | United States

19F Hot Spot MRI of Human Adipose-derived Stem Cells for Breast Reconstruction (CS-1000)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Johns Hopkins University
Sponsor:
Collaborator:
Cosmeticsurg.net
Information provided by (Responsible Party):
Jeff W.M.Bulte, PhD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02035085
First received: December 19, 2013
Last updated: September 13, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Breast Cancer
Drug: CS-1000 labeled SVF cells
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: This is a First-in-man, Phase I Study Utilizing 19F Magnetic Resonance Imaging (MRI) to Track Autologous, Adipose Derived Stem Cells.

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 19F MRI signal over time [ Time Frame: within 18 months ] [ Designated as safety issue: No ]
    The engraftment of transplanted cells will be tracked in ways not possible before, using the total fluorine signal as surrogate marker for cell persistence and survival.


Secondary Outcome Measures:
  • Maintenance of breast contour and volume [ Time Frame: within 18 months ] [ Designated as safety issue: Yes ]
    CTCAE/CTEP scale examination criteria (retraction, atrophy, breast and arm edema, ulceration, telangiectasia, and induration/fibrosis will be used for assessments.


Estimated Enrollment: 6
Study Start Date: September 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CS-1000
Breast cancer patients with RIF 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.
Drug: CS-1000 labeled SVF cells
Patients will undergo autologous transplantation of CS-1000 labelled SVF cells in a sterile environment.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient capable and willing to sign the Informed Consent (see attached document)
  2. Patient must be willing to complete all visits in this study
  3. Female, >18 years of age
  4. Lumpectomy and radiation therapy for breast carcinoma
  5. 18 month disease free survival
  6. No evidence of metastatic disease
  7. Patient is fit for surgery as determined by preoperative medical clearance workup performed by an independent primary care physician.
  8. Negative pregnancy test.

Exclusion Criteria:

  1. Evidence of metastatic disease
  2. Less than 18 months disease-free interval
  3. Unable to undergo MRI:

3a) Metallic implant 3b) Claustrophobic 4) High risk for surgical intervention because of comorbidities 5) Received treatment with an investigational drug within 30 days of screening.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02035085

Contacts
Contact: Jeff Bulte, PhD 443-287-0996 jwmbulte@mri.jhu.edu
Contact: Lorena Gapasin, BSN, RN 410-955-3267 lgapasi1@jhmi.edu

Locations
United States, Maryland
CosmeticSurg Recruiting
Lutherville-Timonium, Maryland, United States, 21093
Contact: Ricardo Rodriguez, MD    410-494-8100    dr.rodriguez@me.com   
Sponsors and Collaborators
Johns Hopkins University
Cosmeticsurg.net
Investigators
Principal Investigator: Jeff WM Bulte, PhD Johns Hopkins University
Study Director: Ricardo Rodriguez, MD Cosmeticsurg.net
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeff W.M.Bulte, PhD, Professor of Radiology, Oncology, Biomedical Engineering, and Chemical & Biomolecular Engineering Director, Cellular Imaging Section, Institute for Cell Engineering, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02035085     History of Changes
Other Study ID Numbers: NA_00086592 
Study First Received: December 19, 2013
Last Updated: September 13, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
19F MRI

ClinicalTrials.gov processed this record on December 02, 2016