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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07175077
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Missouri-Columbia
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bo Lu, MD
Principal Investigator Affiliation	CHAIR & PROFESSOR, DEPARTMENT OF RADIATION ONCOLOGY
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Small-cell Lung Cancer, Brain Metastases

Additional Details

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Brooke McDaniel

[email protected]

573-884-7488

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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