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

NCT ID: NCT07175077

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-09-30

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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

7t MRI

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siemens Medical Solutions

INDUSTRY

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Bo Lu

CHAIR & PROFESSOR, DEPARTMENT OF RADIATION ONCOLOGY

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bo Lu, MD

Role: PRINCIPAL_INVESTIGATOR

CHAIR & PROFESSOR, DEPARTMENT OF RADIATION ONCOLOGY

Locations

University of Missouri

Columbia, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brooke McDaniel

Role: CONTACT

mcdanielbl@health.missouri.edu

573-884-7488

Facility Contacts

Brooke McDaniel

Role: primary

mcdanielbl@health.missouri.edu

(573) 882-7440

Other Identifiers

2122797

Identifier Type: -

Identifier Source: org_study_id