Small-cell Lung CancerNCT07175077
7T Brain MRI Scan for Micro-brain Metastasis (microBM) Detection for Patients With Small-cell Lung Cancer (SCLC), Who Decline Prophylactic Cranial Irradiation (PCI)
An observational study of Small-cell Lung Cancer and Brain Metastases, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Comparison of a 7t MRI to standard of care 1.5t/3t MRI scans to determine if earlier detection of brain metastases are possible on a 7t. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small-cell Lung Cancer, Brain Metastases
- What is being tested?
- 7t MRI
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to Sep 2027
- Phase
- Observational
- 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
Study population: Patients who present to clinic \& who have declined PCI will be presented and offered the study.
Who may be able to join
- Patient must have a histologically confirmed diagnosis of small-cell lung cancer (SCLC). • Patient must have an MRI of the brain, performed within 4 weeks prior to consent, documenting no evidence of brain metastases or leptomeningeal disease.
- Patient also must not have a history of brain metastases or leptomeningeal disease.
- Patient must refuse PCI and agree to surveillance with brain MRI scans (1.5T/3T).
- Patient must be ≥ 18 years of age.
- Patient must have ECOG Performance Status of 0-2
- Patients must be able to tolerate the 7T MRI
Who cannot join
- Patient must not have a contraindication to an MRI, such as implanted metal devices or foreign bodies.
- Patient must not have a contraindication to gadolinium contrast administration during MR imaging.
- Patient must not have other metastatic malignancies requiring current active treatment.
- Pregnant patients are excluded. Pregnancy status will be confirmed verbally.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Missouri
Columbia, Missouri, 65212
Brooke McDaniel, (573) 882-7440, mcdanielbl@health.missouri.edu
Bo Lu, MD
About this study
Comparison of a 7t MRI to standard of care 1.5t/3t MRI scans to determine if earlier detection of brain metastases are possible on a 7t.
Read the detailed description
This study is looking at patients diagnosed with small-cell lung cancer \& have declined prophylactic cranial irradiation. Patients must have had a 1.5t/3t MRI performed within 4 weeks of consenting to the trial that was negative for brain metastases. Patients will then undergo a 7t MRI \& be followed for their standard of care scans for 12 months or until confirmed metastases are detected. Once a patient has confirmed brain mets, their standard of care scans will be used for an analysis compared to the 7t scan to determine if earlier detection of brain micro metastases are feasible.
- Conditions
- Small-cell Lung Cancer, Brain Metastases
- Being tested
- 7t MRI
- Medical subject headings
- Small Cell Lung Carcinoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7t MRIDevice
7t brain MRI followed by up to 12 months of standard of care 1.5t/3t MRI scans
What is being measured
The primary outcome is the main question the study is designed to answer.
7t MRI Brain Metastases Detection
Comparison of 7t MRI to 1.5t/3t to determine if the 7t MRI was able to detect metastases prior to a 1.5t/3t MRI
Measured: 3, 6, 9, 12 months after 7T MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Nov 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-cell Lung CancerStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Medical Solutions
- Responsible party
- Principal investigator, Bo Lu, University of Missouri-Columbia
- Investigators
- Bo Lu, MD, Principal investigator, CHAIR & PROFESSOR, DEPARTMENT OF RADIATION ONCOLOGY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175077
- Sponsor's protocol ID
- 2122797
- Status last verified
- Nov 2025
- First submitted
- 5 Sep 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7T Brain MRI Scan for Micro-brain Metastasis (microBM) Detection for Patients With Small-cell Lung Cancer (SCLC), Who Decline Prophylactic Cranial Irradiation (PCI)
- ClinicalTrials.gov ID
- NCT07175077
- Acronym / sponsor ID
- 2122797
- Conditions
- Small-cell Lung Cancer, Brain Metastases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Siemens Medical Solutions
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 16 Sep 2025 (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.
Comparison of a 7t MRI to standard of care 1.5t/3t MRI scans to determine if earlier detection of brain metastases are possible on a 7t.
Detailed description
This study is looking at patients diagnosed with small-cell lung cancer \& have declined prophylactic cranial irradiation. Patients must have had a 1.5t/3t MRI performed within 4 weeks of consenting to the trial that was negative for brain metastases. Patients will then undergo a 7t MRI \& be followed for their standard of care scans for 12 months or until confirmed metastases are detected. Once a patient has confirmed brain mets, their standard of care scans will be used for an analysis compared to the 7t scan to determine if earlier detection of brain micro metastases are feasible.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present to clinic \& who have declined PCI will be presented and offered the study.
Key inclusion criteria (6 listed)
- Patient must have a histologically confirmed diagnosis of small-cell lung cancer (SCLC). • Patient must have an MRI of the brain, performed within 4 weeks prior to consent, documenting no evidence of brain metastases or leptomeningeal disease.
- Patient also must not have a history of brain metastases or leptomeningeal disease.
- Patient must refuse PCI and agree to surveillance with brain MRI scans (1.5T/3T).
- Patient must be ≥ 18 years of age.
- Patient must have ECOG Performance Status of 0-2
Key exclusion criteria (4 listed)
- Patient must not have a contraindication to an MRI, such as implanted metal devices or foreign bodies.
- Patient must not have a contraindication to gadolinium contrast administration during MR imaging.
- Patient must not have other metastatic malignancies requiring current active treatment.
- Pregnant patients are excluded. Pregnancy status will be confirmed verbally.
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 |
|---|---|---|
| 7t MRI7t brain MRI followed by up to 12 months of standard of care 1.5t/3t MRI scans | Device | – |
Primary outcome
7t MRI Brain Metastases Detection
Time frame: 3, 6, 9, 12 months after 7T MRI
Comparison of 7t MRI to 1.5t/3t to determine if the 7t MRI was able to detect metastases prior to a 1.5t/3t MRI
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 2 Dec 2025.
- 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.
Bo Lu, MD principal investigator
CHAIR & PROFESSOR, DEPARTMENT OF RADIATION ONCOLOGY
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 Small-cell Lung Cancer and Brain Metastases, run by University of Missouri-Columbia 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Dec 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?
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?
Contact Brooke McDaniel (573-884-7488, mcdanielbl@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7t MRI Brain Metastases Detection (time frame: 3, 6, 9, 12 months after 7T MRI). 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 2 Dec 2025.