19F Hot Spot MRI of Human Adipose-derived Stem Cells for Breast Reconstruction

  • STATUS
    Recruiting
  • End date
    Dec 20, 2022
  • participants needed
    6
  • sponsor
    Johns Hopkins University
Updated on 20 January 2020
Investigator
Jeff Bulte, PhD
Primary Contact
CosmeticSurg (6.5 mi away) Contact
carcinoma
metastasis
breast carcinoma
lumpectomy
breast reconstruction

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.

Details
Treatment CS-1000 labeled SVF cells
Clinical Study IdentifierNCT02035085
SponsorJohns Hopkins University
Last Modified on20 January 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have Breast Cancer?
Patient capable and willing to sign the Informed Consent (see attached document)
Patient must be willing to complete all visits in this study
Female, >18 years of age
Lumpectomy and radiation therapy for breast carcinoma
18 month disease free survival
No evidence of metastatic disease
Patient is fit for surgery as determined by preoperative medical clearance workup performed by an independent primary care physician
Negative pregnancy test

Exclusion Criteria

Evidence of metastatic disease
Less than 18 months disease-free interval
Unable to undergo MRI
a) 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
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