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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: mcdanielbl@health.missouri.edu
• Phone: 573-884-7488

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.