Imaging of Type 1 Diabetes Progression

Type 1 Diabetes Clinical Trial

Official title:

Ferumoxytol Enhanced Magnetic Resonance Imaging of Type 1 Diabetes Progression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01521520
• Other study ID #: 2011P001957
• Secondary ID: P01AI054904
• Status: Active, not recruiting
• Phase: N/A
• First received: January 26, 2012
• Last updated: April 6, 2017
• Start date: January 2012

Study information

• Verified date: April 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Type 1 diabetes results from the autoimmune destruction of the insulin-producing beta cells of the islets of Langerhans of the pancreas. Initially, diabetes is usually clinically silent with immune cells invading the pancreatic islets, a process termed insulitis, which eventually leads to loss of beta cells in the islets. If enough beta cells are destroyed, the body can not make enough insulin to maintain blood sugars in the normal range and clinical diabetes develops. The purpose of this study is to assess the ability of magnetic resonance imaging with ferumoxytol to detect changes in the pancreas associated with the insulitis of type 1 diabetes.

Description:

This study is designed to monitor changes associated with the development of autoimmune diabetes. A magnetic resonance imaging (MRI) based technique will be used to noninvasively measure changes within the pancreas associated with the development of autoimmune diabetes. The iron-containing drug ferumoxytol will be used as an intravenous MRI contrast agent for this study.

Individuals will be asked to participate one time, for 1-year, or over a 2-year period. During the development phase of the study, each imaging series will consist of 3 or more MRI scans. At the initial imaging visit a pre-ferumoxytol scan will be done, followed by ferumoxytol injection, and then an immediate post-injection scan. The subsequent scans will be concluded within 96 hours of ferumoxytol injection (typically at 48 hours). Those who participate for 1-year will have repeat imaging at approximate times 0, 6 months, and 12 months. Those who participate for 2-years will have repeat imaging at approximate times 0, 3, 6, 12, 18, and 24 months after enrollment.

Measurements of autoimmunity and metabolic parameters (collected as part of collaborating diabetes clinical studies) will be used in the data analysis for the longitudinal portion of the study. Stimulated C-peptide will be measured as a marker of endogenous insulin production capacity and beta-cell mass.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participation in a collaborating diabetes clinical trial

• Able to understand written consent document and HIPAA authorization prior to initiation of study related procedures and are willing to participate

Exclusion Criteria:

• Known allergy to ferumoxytol or iron

• Individuals who are pregnant or lactating

• Iron saturation above the upper limit of normal

• Individuals with a counter-indication to MRI, such as the presence of metallic prostheses or implanted metal device (e.g., infusion pump, defibrillator)

• Individuals with known clinical conditions that may lead to iron overload including hemochromatosis, cirrhosis, or sickle cell disease

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• ferumoxytol
Ferumoxytol at a dose of between 1 and 6 mg iron/kg body weight (maximum 510 mg/injection) will be administered via intravenous injection. Ferumoxytol will be administered with each series of MRIs.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Jason Gaglia	Harvard Medical School, National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gaglia JL, Guimaraes AR, Harisinghani M, Turvey SE, Jackson R, Benoist C, Mathis D, Weissleder R. Noninvasive imaging of pancreatic islet inflammation in type 1A diabetes patients. J Clin Invest. 2011 Jan;121(1):442-5. doi: 10.1172/JCI44339. Epub 2010 Dec 1. — View Citation