T2* MRI Analysis for Sarcoma

NCT03658343 | Completed FDA Device

• 2 other identifiers: 2018077115P30CA086862
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiotherapy; Magnetic Resonance Imaging; Sarcoma

Keywords

soft tissue sarcoma

Outcome Measures

Primary Outcomes (1)

• Change in ferric iron levels detected by T2* MRI

  Change from baseline in Fe3+ iron levels

  baseline and 8 weeks

Secondary Outcomes (1)

• Change in ferrous iron levels detected by T2* MRI

  Baseline and 8 weeks

Study Arms (1)

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

Interventions

T2* Imaging DIAGNOSTIC_TEST

T2\* imaging sequences for MRI

Also known as: magnetic resonance imaging, T2-star, T2* MRI

T2* Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \< 18 years of age

Sponsors & Collaborators

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

Study Sites (1)

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissue if further surgery

MeSH Terms

Conditions

Sarcoma

Interventions

Magnetic Resonance Imaging; Magnetic Resonance Myelography

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Myelography; Neuroradiography; Neuroimaging; Radiography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Bryan Allen, MD, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 5, 2018
• Study Start: September 18, 2018
• Primary Completion: February 25, 2022
• Study Completion: February 25, 2022
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)