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

NCT07175077 | Recruiting FDA Device

• 1 other identifier: 2122797
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Small-cell Lung Cancer; Brain Metastases

Outcome Measures

Primary Outcomes (1)

• 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

  3, 6, 9, 12 months after 7T MRI

Interventions

7t MRI DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who present to clinic \& who have declined PCI will be presented and offered the study.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Siemens Medical Solutions: collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Bo Lu, MD

  CHAIR & PROFESSOR, DEPARTMENT OF RADIATION ONCOLOGY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brooke McDaniel

CONTACT

573-884-7488; mcdanielbl@health.missouri.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CHAIR & PROFESSOR, DEPARTMENT OF RADIATION ONCOLOGY

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 16, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)