T2* MRI Analysis for Sarcoma | NCT03658343

Studies
T2* MRI Analysis for Sarcoma

NCT03658343

Sponsor

Bryan Allen

Status

Completed

Last Update Posted

Feb 21, 2025Actual

Enrollment

8Actual

Phase

Not provided

Conditions

Radiotherapy
Magnetic Resonance Imaging
Sarcoma

Interventions

T2* Imaging

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5P30CA086862	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 18, 2018Actual

Primary Completion Date

Feb 25, 2022Actual

Completion Date

Feb 25, 2022Actual

First Submitted Date

Aug 31, 2018

First Submission Date that Met QC Criteria

Aug 31, 2018

First Posted Date

Sep 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2025

Last Update Posted Date

Feb 21, 2025Actual

Name	Class
Holden Comprehensive Cancer Center	OTHER
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
T2* Imaging	Diagnostic Test	T2* imaging sequences for MRI	T2* Imaging

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bryan Allen, MD, PhD	University of Iowa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Holden Comprehensive Cancer Center		Iowa City	Iowa	52242	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Participants may opt in for individual data sharing; the data of those participants who have opted-in will be shared per plan.

Types

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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012509	Sarcoma

Ancestor Terms

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008279	Magnetic Resonance Imaging
D000095497	Magnetic Resonance Myelography

Ancestor Terms

ID	Term
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided