Clincosm LogoSign in Get a demo

T2* MRI Analysis for Sarcoma

Sponsor
Bryan Allen (Other)
Overall Status
Recruiting
CT.gov ID
NCT03658343
Collaborator
Holden Comprehensive Cancer Center (Other), National Cancer Institute (NCI) (NIH)
15
Enrollment
1
Location
1
Arm
99.4
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: T2* Imaging
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
An Exploratory, Pilot Study Evaluating T2* Imaging for Adult Sarcoma
Actual Study Start Date :
Sep 18, 2018
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in ferric iron levels detected by T2* MRI [baseline and 8 weeks]

      Change from baseline in Fe3+ iron levels

    Secondary Outcome Measures

    1. Change in ferrous iron levels detected by T2* MRI [Baseline and 8 weeks]

      Change from baseline in Fe2+ iron levels

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Holden Comprehensive Cancer Center Iowa City Iowa United States 52242

    Sponsors and Collaborators

    • Bryan Allen
    • Holden Comprehensive Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Bryan Allen, MD, PhD, University of Iowa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bryan Allen, Assistant Professor, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT03658343
    Other Study ID Numbers:
    • 201807711
    • 5P30CA086862
    First Posted:
    Sep 5, 2018
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Bryan Allen, Assistant Professor, University of Iowa
    soft tissue sarcoma
    Additional relevant MeSH terms:
    Sarcoma

    Study Results

    No Results Posted as of Aug 15, 2022