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

Study Overview
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Brief Summary
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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.

Official Title
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This is a First-in-man, Phase I Study Utilizing 19F Magnetic Resonance Imaging (MRI) to Track Autologous, Adipose Derived Stem Cells.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: CS-1000 labeled SVF cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CS-1000<br>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<br>* Patients will undergo autologous transplantation of CS-1000 labelled SVF cells in a sterile environment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 19F MRI signal over time | 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. | within 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of breast contour and volume | CTCAE/CTEP scale examination criteria (retraction, atrophy, breast and arm edema, ulceration, telangiectasia, and induration/fibrosis will be used for assessments. | within 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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19F MRI