7T MRI to detect tiny brain metastases in adults with small-cell lung cancer who decline preventive cranial irradiation.

7T Brain MRI Scan for Micro-brain Metastasis (microBM) Detection for Patients With Small-cell Lung Cancer (SCLC), Who Decline Prophylactic Cranial Irradiation (PCI)

Try a higher-strength 7T brain MRI to see if it finds tiny brain metastases earlier in adults with small-cell lung cancer who decline preventive cranial radiation.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Missouri-Columbia (other)
• Locations: 1 site (Columbia, Missouri)
• Trial ID: NCT07175077 on ClinicalTrials.gov

What this trial studies

This observational study enrolls adults with histologically confirmed small-cell lung cancer who have refused prophylactic cranial irradiation and have a negative 1.5T/3T brain MRI within 4 weeks before consent. Participants will undergo a single 7T brain MRI and then continue routine standard-of-care 1.5T/3T MRI surveillance for up to 12 months or until brain metastases are confirmed. The timing and imaging appearance of any confirmed metastases on standard scans will be compared to the initial 7T scan to determine whether 7T detects micro-metastases earlier. Imaging is performed at the University of Missouri and analyses will compare detection rates and lead time between modalities.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed small-cell lung cancer, ECOG 0-2, a negative 1.5T/3T brain MRI within 4 weeks, who refuse prophylactic cranial irradiation and can tolerate a 7T MRI are ideal candidates.

Not a fit: Patients with existing brain metastases, contraindications to MRI or gadolinium, other active metastatic cancers requiring treatment, or who are pregnant are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, earlier detection of brain micro-metastases could allow faster treatment and potentially preserve neurological function.

How similar studies have performed: High-field 7T MRI has shown improved anatomic detail in small studies, but its specific ability to detect micro-brain metastases in small-cell lung cancer is relatively novel and not yet proven.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where this trial is running

Columbia, Missouri

• University of Missouri — Columbia, Missouri, United States (RECRUITING)

Study contacts

• Principal investigator: Bo Lu, MD — CHAIR & PROFESSOR, DEPARTMENT OF RADIATION ONCOLOGY
• Study coordinator: Brooke McDaniel

Conditions: Small-cell Lung Cancer, Brain Metastases