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NCT05746325 · ClinicalTrials.gov registry record · NA
Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer
A NA study of Stage IV Lung Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- NA
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT05746325: Recruiting NA study of Stage IV Lung Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by Mayo Clinic.
NCT05746325 is a NA study of Stage IV Lung Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8 that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 5 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05746325, a NA study of Stage IV Lung Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast or lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Patients wear the portable Novo TTF-200T device that produces electric fields to target areas on the body to stop the growth of tumor cells. The information from this study will help researchers develop a better treatment for leptomeningeal metastases in the future.
Primary Outcome
Will be measured by incidence of grade 3 or greater non-hematologic adverse events that persist despite temporary interruption of treatment and maximal medical management (i.e., grade 3 or greater non-hematologic toxicities that are not responsive to cessation of treatment and administration of supportive care). Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Lumbar Puncture
- PROCEDURE Magnetic Resonance Imaging
- DEVICE Medical Device Usage and Evaluation
- OTHER Digital Photography
Study Locations (1)
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2023-04-07 |
| Est. Completion | 2027-03-01 |
| Phase | NA |
What NCT05746325 shows while recruiting
NCT05746325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (95% lower).
The record links to 5 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05746325 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05746325 about?
NCT05746325 is a clinical study titled "Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer". This clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast or lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Patients wear the port...
What is the current status of trial NCT05746325?
This trial is currently recruiting. It is a NA study. The enrollment target is 5 participants. The study started on 2023-04-07. Estimated completion is 2027-03-01.
What conditions does trial NCT05746325 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Leptomeninges, Metastatic Lung Carcinoma.
What interventions are being tested in trial NCT05746325?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Lumbar Puncture (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Medical Device Usage and Evaluation (DEVICE), Digital Photography (OTHER).
Who is sponsoring clinical trial NCT05746325?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05746325 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05746325's enrollment target sits among peer trials
5 78th of 81 higher than 1 of 81 other Stage IV Lung Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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