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NCT03658343 Clinical Trial

T2* MRI Analysis for Sarcoma

Sarcoma Clinical Trial

Official title:
An Exploratory, Pilot Study Evaluating T2* Imaging for Adult Sarcoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03658343
Other study ID # 201807711
Secondary ID 5P30CA086862
Status Recruiting
Phase N/A
First received
Last updated
Start date September 18, 2018
Est. completion date December 31, 2026

Study information
Verified date October 2023
Source University of Iowa
Contact Bryan G. Allen, MD, PhD
Phone (319) 356-3693
Email bryan-allen@uiowa.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date December 31, 2026
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• T2* Imaging
T2* imaging sequences for MRI

Locations
Country Name City State
United States Holden Comprehensive Cancer Center Iowa City Iowa

Sponsors (3)
Lead Sponsor Collaborator
Bryan Allen Holden Comprehensive Cancer Center, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in ferric iron levels detected by T2* MRI Change from baseline in Fe3+ iron levels baseline and 8 weeks
Secondary Change in ferrous iron levels detected by T2* MRI Change from baseline in Fe2+ iron levels Baseline and 8 weeks
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