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T2* MRI Analysis for Sarcoma

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ClinicalTrials.gov Identifier: NCT03658343
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : December 10, 2018
Sponsor:
Collaborators:
Holden Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bryan Allen, University of Iowa

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
Radiotherapy Magnetic Resonance Imaging Sarcoma Diagnostic Test: T2* Imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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 : September 18, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in ferric iron levels detected by T2* MRI [ Time Frame: baseline and 8 weeks ]
    Change from baseline in Fe3+ iron levels


Secondary Outcome Measures :
  1. Change in ferrous iron levels detected by T2* MRI [ Time Frame: Baseline and 8 weeks ]
    Change from baseline in Fe2+ iron levels



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658343


Contacts
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Contact: Bryan G. Allen, MD, PhD (319) 356-3693 bryan-allen@uiowa.edu
Contact: Heather Brown, RN, BAN, OCN (319) 384-7912 heather-brown@uiowa.edu

Locations
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United States, Iowa
Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Sandy Vollstedt, RN, BSN, OCN    319-353-7143    sandy-vollstedt@uiowa.edu   
Contact: Heather Brown, RN, BAN, OCN    (319) 384-7912    heather-brown@uiowa.edu   
Principal Investigator: Bryan Allen, MD, PhD         
Sponsors and Collaborators
Bryan Allen
Holden Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Bryan Allen, MD, PhD University of Iowa

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Responsible Party: Bryan Allen, Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03658343     History of Changes
Other Study ID Numbers: T2*Sarc
5P30CA086862 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participants may opt in for individual data sharing; the data of those participants who have opted-in will be shared per plan.
Supporting Materials: Informed Consent Form (ICF)
Time Frame: After completion and analysis of data
Access Criteria: Interested investigators should contact the study PI. Depending upon the data requested, an IRB application may be necessary.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Bryan Allen, University of Iowa:
soft tissue sarcoma

Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms