T2* MRI Analysis for Sarcoma

October 18, 2023 updated by: Bryan Allen

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • Holden Comprehensive Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bryan Allen, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Time Frame: baseline and 8 weeks
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
Time Frame: Baseline and 8 weeks
Change from baseline in Fe2+ iron levels
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2026

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)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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