Clinical trial NCT02035085: 19F Hot Spot MRI of Human Adipose-derived Stem Cells for Breast Reconstruction
Official title: This is a First-in-man, Phase I Study Utilizing 19F Magnetic Resonance Imaging (MRI) to Track Autologous, Adipose Derived Stem Cells.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Breast Cancer
Keywords: 19F MRI
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Cosmeticsurg.net
First posted: 2014-01-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: 19F MRI signal over time
timeFrame: within 18 months
Secondary outcomes:
measure: Maintenance of breast contour and volume
timeFrame: within 18 months
Other outcomes:
Locations:
city: Lutherville-Timonium
country: United States
facility: CosmeticSurg
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jeff WM Bulte, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cosmeticsurg.net
name: Ricardo Rodriguez, MD
role: STUDY_DIRECTOR
References:
citation: Rose LC, Kadayakkara DK, Wang G, Bar-Shir A, Helfer BM, O'Hanlon CF, Kraitchman DL, Rodriguez RL, Bulte JW. Fluorine-19 Labeling of Stromal Vascular Fraction Cells for Clinical Imaging Applications. Stem Cells Transl Med. 2015 Dec;4(12):1472-81. doi: 10.5966/sctm.2015-0113. Epub 2015 Oct 28.