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

Phase 1

Withdrawn

• Conditions: Breast Cancer
• Interventions: Drug: CS-1000 labeled SVF cells

• Registration Number: NCT02035085
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-14
• Study Start: 2014-06
• Status Verified: 2022-06
• Primary Completion: 2022-06
• Study Completion: 2022-06
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CS-1000	CS-1000 labeled SVF cells	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.

Primary Outcome Measures

Name	Time	Method
19F MRI signal over time	within 18 months	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

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

Trial Locations

Locations (1)

CosmeticSurg; 🇺🇸 Lutherville-Timonium, Maryland, United States