T2* MRI Analysis for Sarcoma

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcoma; Magnetic Resonance Imaging; Radiotherapy
• Intervention / Treatment: Diagnostic test: T2* Imaging

• Study Type: Observational
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Holden Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with pathologically confirmed sarcoma that have been recommended for standard of care radiation therapy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
T2* Imaging; Participants undergo T2* MRI imaging before beginning their course of radiation therapy and then after completing radiation therapy, about 2 weeks before their surgery.	Diagnostic test: T2* Imaging; T2* imaging sequences for MRI; Other Names: magnetic resonance imaging; T2-star; T2* MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ferric iron levels detected by T2* MRI	Change from baseline in Fe3+ iron levels	baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ferrous iron levels detected by T2* MRI	Change from baseline in Fe2+ iron levels	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Bryan Allen
• Collaborators: National Cancer Institute (NCI); Holden Comprehensive Cancer Center
• Investigators: Principal Investigator: Bryan Allen, MD, PhD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2018
• Primary Completion (Actual): February 25, 2022
• Study Completion (Actual): February 25, 2022

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: soft tissue sarcoma
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma
• Other Study ID Numbers: 201807711; 5P30CA086862 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• 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