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NCT Number: NCT07175077

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Missouri

Columbia, Missouri, 65212, United States

Location status: Recruiting

Location contact

Bo Lu, MD

PRINCIPAL_INVESTIGATOR

Brooke McDaniel

CONTACT

[email protected]

(573) 882-7440

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

7t MRI

Device

7t brain MRI followed by up to 12 months of standard of care 1.5t/3t MRI scans

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Brooke McDaniel

CONTACT

[email protected]

573-884-7488

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • Siemens Medical Solutions

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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