Smartwatch could alert doctors to brain cancer complications before they worsen
NCT ID NCT07704034
First seen Jul 15, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This study tests whether a consumer smartwatch (Apple Watch or Samsung Galaxy Watch) can continuously monitor people with leptomeningeal metastasis, a condition where cancer spreads to the fluid and membranes around the brain and spinal cord. The watch collects data on movement and symptoms, and if it detects early signs of neurological decline, it automatically alerts the participant's doctor. The goal is to see if this early warning system can reduce hospitalizations by enabling faster medical intervention.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Apple Watch Series 6+ or Samsung Galaxy Watch 4+ with a cross-platform app for passive monitoring and active alerts
- What this could lead to
- If successful, this approach could provide a way to catch neurological decline early in people with leptomeningeal metastasis, potentially reducing hospital stays and improving quality of life.
- What could go wrong
- This is a small, early feasibility study, so the smartwatch alerts may not reliably predict decline or reduce hospitalizations. The technology might also be burdensome for participants to use consistently.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Nov 2026
An estimate. Start dates often move.
- Expected to finish
-
Nov 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants must have leptomeningeal metastasis (LMM) diagnosed per clinical, imaging, and/or CSF/cytology criteria (cytology, flow cytometry, or circulating tumor DNA), arising from any solid or hematologic tumor primary. * Participants must be undergoing active anti-cancer therapy (systemic, intrathecal, and/or radiation) or active surveillance for LMM. * Age ≥18 years at the time of study enrollment. Because no safety or dosing data are available for wearable monitoring studies in children with LMM, participants under 18 years of age are excluded. * Karnofsky Performance Status (KPS) ≥50 at time of study enrollment \[See Appendix I\], to ensure feasibility of wearing the device for ≥10 hours/day. * Participants must have access to a compatible smartphone: * iPhone running iOS 16 or higher and willingness to wear Apple Watch ≥10 hours/day; OR * Android smartphone compatible with the study application and willingness to wear Samsung Galaxy Watch ≥10 hours/day. * Ability to provide informed consent (or a legally authorized representative \[LAR\] is available and willing to provide consent on the participant's behalf, if appropriate). Exclusion Criteria: * Anticipated life expectancy \<4 weeks at time of screening, per the treating physician. * Severe dermatologic or musculoskeletal conditions precluding smartwatch wear (e.g., significant skin conditions on the wrist or forearm where the device will be placed, including tattoos that may substantially interfere with optical sensor function). * Inability to adhere to study procedures after training, as assessed by the study team at enrollment. * No access to a compatible smartphone (participant or caregiver) to interface with the watch application for symptom documentation and data transfer. * Inability to give informed consent due to severe aphasia, severe cognitive impairment, or other language barrier, unless a legally authorized representative is available and willing to participate.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Leptomeningeal metastasis are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A multicenter phase 1 study to determine the safety and efficacy of multiple doses at defined intervals of rhenium (186Re) obisbemeda (Rhenium-186 NanoLiposome, 186RNL) administered via intraventricular catheter for any primary solid tumor cancer with leptomeningeal metastases
- Can radiation spare the brain while fighting cancer in the spinal fluid?
- Can a Direct-to-Brain chemo route outsmart resistant lung cancer?
- Spinal injection of dual immunotherapy plus chemotherapy targets cancer spread to brain lining
- Spinal fluid injection of Dual-Target antibody and chemotherapy shows promise for deadly cancer complication
- Triple therapy targets tough brain metastases in lung cancer