RadiotherapyNCT03658343
T2* MRI Analysis for Sarcoma
An observational study of Radiotherapy and Magnetic Resonance Imaging, run by Bryan Allen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy, Magnetic Resonance Imaging, Sarcoma
- What is being tested?
- T2* Imaging
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2018to 25 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pathologically confirmed sarcoma that have been recommended for standard of care radiation therapy
Who may be able to join
- 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
Who cannot join
- < 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
About this study
Official title: 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.
- Conditions
- Radiotherapy, Magnetic Resonance Imaging, Sarcoma
- Being tested
- T2* Imaging
- Keywords
- soft tissue sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T2* ImagingDiagnostic test
Also called magnetic resonance imaging, T2-star, T2* MRI
T2* imaging sequences for MRI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: T2* Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ferric iron levels detected by T2* MRI
Change from baseline in Fe3+ iron levels
Measured: baseline and 8 weeks
Secondary outcomes (1)
Change in ferrous iron levels detected by T2* MRI
Change from baseline in Fe2+ iron levels
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start18 Sep 2018
- Primary completion25 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bryan Allen
- Sponsor type
- University, hospital or other
- Collaborators
- Holden Comprehensive Cancer Center, National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Bryan Allen, University of Iowa
- Investigators
- Bryan Allen, MD, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658343
- Sponsor's protocol ID
- 201807711
- Other IDs
- 5P30CA086862
- Status last verified
- Feb 2025
- First submitted
- 31 Aug 2018
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Participants may opt in for individual data sharing; the data of those participants who have opted-in will be shared per plan.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Pilot Study Evaluating T2* Imaging for Adult Sarcoma
- ClinicalTrials.gov ID
- NCT03658343
- Acronym / sponsor ID
- 201807711
- Conditions
- Radiotherapy, Magnetic Resonance Imaging, Sarcoma
- Keywords
- soft tissue sarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Bryan AllenUniversity, hospital or other
- Collaborators
- Holden Comprehensive Cancer Center, National Cancer Institute (NCI)
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T2* Imaging | – | Diagnostic Test: T2* ImagingParticipants undergo T2* MRI imaging before beginning their course of radiation therapy and then after completing radiation therapy, about 2 weeks before their surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pathologically confirmed sarcoma that have been recommended for standard of care radiation therapy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- < 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T2* ImagingAlso: magnetic resonance imaging, T2-star, T2* MRIT2* imaging sequences for MRI | Diagnostic test | T2* Imaging |
Primary outcome
Change in ferric iron levels detected by T2* MRI
Time frame: baseline and 8 weeks
Change from baseline in Fe3+ iron levels
1 secondary outcome
Change in ferrous iron levels detected by T2* MRI
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: Yes. Participants may opt in for individual data sharing; the data of those participants who have opted-in will be shared per plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Allen, MD, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy and Magnetic Resonance Imaging, run by Bryan Allen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ferric iron levels detected by T2* MRI (time frame: baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025; AzTrials last refreshed its copy on 4 Nov 2026.