Back to resultsT2* MRI Analysis for Sarcoma
Primary Purpose
Radiotherapy, Magnetic Resonance Imaging, Sarcoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
T2* Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Radiotherapy focused on measuring soft tissue sarcoma
Eligibility Criteria
Inclusion Criteria:
- pathologically confirmed Sarcoma, by biopsy or excision
- prescribed radiation therapy as per standard of care
- treatment to begin within 5 weeks after surgery or biopsy
- ECOG 0, 1, or 2
- ability and willingness to provide informed consent
Exclusion Criteria:
- < 18 years of age
Sites / Locations
- Holden Comprehensive Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
T2* Imaging
Arm Description
Participants undergo T2* MRI imaging before beginning their course of radiation therapy and then after completing radiation therapy, about 2 weeks before their surgery.
Outcomes
Primary Outcome Measures
Change in ferric iron levels detected by T2* MRI
Change from baseline in Fe3+ iron levels
Secondary Outcome Measures
Change in ferrous iron levels detected by T2* MRI
Change from baseline in Fe2+ iron levels
Full Information
NCT ID
NCT03658343
First Posted
August 31, 2018
Last Updated
October 18, 2023
Sponsor
Bryan Allen
Collaborators
Holden Comprehensive Cancer Center, National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03658343
Brief Title
T2* MRI Analysis for Sarcoma
Official Title
An Exploratory, Pilot Study Evaluating T2* Imaging for Adult Sarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bryan Allen
Collaborators
Holden Comprehensive Cancer Center, National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
T2* imaging is a method to identify labile iron pools in tumor cells. These iron pools may be linked to better treatment outcomes for specific types of therapy. This is a small pilot study to see if radiation therapy changes the amount of iron in a sarcoma tumor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiotherapy, Magnetic Resonance Imaging, Sarcoma
Keywords
soft tissue sarcoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
T2* Imaging
Arm Type
Experimental
Arm Description
Participants undergo T2* MRI imaging before beginning their course of radiation therapy and then after completing radiation therapy, about 2 weeks before their surgery.
Intervention Type
Diagnostic Test
Intervention Name(s)
T2* Imaging
Other Intervention Name(s)
magnetic resonance imaging, T2-star, T2* MRI
Intervention Description
T2* imaging sequences for MRI
Primary Outcome Measure Information:
Title
Change in ferric iron levels detected by T2* MRI
Description
Change from baseline in Fe3+ iron levels
Time Frame
baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in ferrous iron levels detected by T2* MRI
Description
Change from baseline in Fe2+ iron levels
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pathologically confirmed Sarcoma, by biopsy or excision
prescribed radiation therapy as per standard of care
treatment to begin within 5 weeks after surgery or biopsy
ECOG 0, 1, or 2
ability and willingness to provide informed consent
Exclusion Criteria:
< 18 years of age
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bryan G. Allen, MD, PhD
Phone
(319) 356-3693
Email
bryan-allen@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Brown, RN, BAN, OCN
Phone
(319) 384-7912
Email
heather-brown@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Allen, MD, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandy Vollstedt, RN, BSN, OCN
Phone
319-353-7143
Email
sandy-vollstedt@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Heather Brown, RN, BAN, OCN
Phone
(319) 384-7912
Email
heather-brown@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Bryan Allen, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Participants may opt in for individual data sharing; the data of those participants who have opted-in will be shared per plan.
IPD Sharing Time Frame
After completion and analysis of data
IPD Sharing Access Criteria
Interested investigators should contact the study PI. Depending upon the data requested, an IRB application may be necessary.
Learn more about this trial
T2* MRI Analysis for Sarcoma
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