Brain MetastasesNCT04246879
MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases
A study testing MRI in people with Brain Metastases, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to test whether an additional magnetic resonance image (MRI) sequence can improve the ability to distinguish radiation damage from tumor recurrence in participants with brain metastasis who have previously been treated with stereotactic radiosurgery (SRS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2021to 24 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adult patients, age ≥18
- Metastatic malignancy with at least 1 brain metastasis previously treated with SRS
- Patients may have also received whole brain radiation therapy (WBRT) for management of brain metastatic disease but this is not required for study participation
- Patients must have been diagnosed with a metastatic solid tumor of any histological type except small cell lung cancer (SCLC), or lymphoma.
- Radiographic progression on post-SRS imaging at previously treated SRS site(s)
- Must be a candidate for brain surgery as determined by treating neurosurgeon and/or anesthesia team
- Patients must sign study-specific informed consent prior to study entry
Who cannot join
- Poor surgical candidate as determined by treating neurosurgeon and/or anesthesia team
- Unable to undergo contrasted MRI (e.g. incompatible medical device, inadequate renal function per standard institutional clinical protocol, contrast allergy)
- Small cell lung cancer (SCLC) or lymphoma histology
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: Diagnostic Accuracy of Delayed MRI Contrast Enhancement Characteristics and Radiation Necrosis Following Stereotactic Radiosurgery (SRS) for Brain Metastases
The purpose of this study is to test whether an additional magnetic resonance image (MRI) sequence can improve the ability to distinguish radiation damage from tumor recurrence in participants with brain metastasis who have previously been treated with stereotactic radiosurgery (SRS).
- Conditions
- Brain Metastases
- Being tested
- MRI
- Keywords
- Laser Interstitial Thermal Therapy (LITT), Stereotactic radiosurgery (SRS), Magnetic resonance image (MRI)
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Subjects undergo one additional delayed MRI sequence
| Study group | Role | What they receive |
|---|---|---|
| MRI | Experimental | Not described Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of positive MRI sequences along with positive tumor biopsies
true tumor will be detected by delayed MRI as determined by biopsy
Measured: baseline
number of negative MRI sequences along with negative tumor biopsies
absence of tumor will be detected by delayed MRI as determined by biopsy
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start19 Jul 2021
- Primary completion19 Mar 2025
- Study completion24 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Floyd, M.D. Ph.D., Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246879
- Sponsor's protocol ID
- Pro00103163
- Status last verified
- May 2026
- First submitted
- 28 Jan 2020
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Delayed MRI Contrast Enhancement Characteristics and Radiation Necrosis Following Stereotactic Radiosurgery (SRS) for Brain Metastases
- ClinicalTrials.gov ID
- NCT04246879
- Acronym / sponsor ID
- Pro00103163
- Conditions
- Brain Metastases
- Keywords
- Laser Interstitial Thermal Therapy (LITT), Stereotactic radiosurgery (SRS), Magnetic resonance image (MRI)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 24 Mar 2027 (estimated)
- First posted
- 29 Jan 2020 (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.
The purpose of this study is to test whether an additional magnetic resonance image (MRI) sequence can improve the ability to distinguish radiation damage from tumor recurrence in participants with brain metastasis who have previously been treated with stereotactic radiosurgery (SRS).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI | Experimental | Other: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients, age ≥18
- Metastatic malignancy with at least 1 brain metastasis previously treated with SRS
- Patients may have also received whole brain radiation therapy (WBRT) for management of brain metastatic disease but this is not required for study participation
- Patients must have been diagnosed with a metastatic solid tumor of any histological type except small cell lung cancer (SCLC), or lymphoma.
- Radiographic progression on post-SRS imaging at previously treated SRS site(s)
Key exclusion criteria (3 listed)
- Poor surgical candidate as determined by treating neurosurgeon and/or anesthesia team
- Unable to undergo contrasted MRI (e.g. incompatible medical device, inadequate renal function per standard institutional clinical protocol, contrast allergy)
- Small cell lung cancer (SCLC) or lymphoma histology
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 |
|---|---|---|
| MRISubjects undergo one additional delayed MRI sequence | Other | MRI |
Primary outcome
number of positive MRI sequences along with positive tumor biopsies
Time frame: baseline
true tumor will be detected by delayed MRI as determined by biopsy
number of negative MRI sequences along with negative tumor biopsies
Time frame: baseline
absence of tumor will be detected by delayed MRI as determined by biopsy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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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.
Scott Floyd, M.D. Ph.D. principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Brain Metastases, run by Duke University 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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
number of positive MRI sequences along with positive tumor biopsies (time frame: baseline). The study lists 2 primary outcomes in all. 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 6 May 2026.