Leptomeningeal MetastasisNANO-LMNCT06417710
Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis
An observational study of Leptomeningeal Metastasis and Leptomeningeal Disease, run by University of Zurich at 3 sites in 3 countries.
Trial summary
The goal of this project is to develop and validate a reproducible scorecard for the neurological assessment of patients with leptomeningeal metastases that can be used in clinical trials including such patients, as well as in clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptomeningeal Metastasis, Leptomeningeal Disease, Leptomeningeal Neoplasms
- What is being tested?
- Neurological Assessment
- How many people
- 200 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 30 Jan 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with leptomeningeal metastases from various extra-central nervous system (CNS) solid primary tumors for whom a tumor-specific treatment is planned
Who may be able to join
- Adult patients (18 years or more), female or male
- Histologically confirmed diagnosis of extra-CNS primary solid cancer
- Diagnosis of leptomeningeal metastases confirmed or probable per EANO ESMO criteria
- Performance status compatible with enrolment into clinical trials
- Ability to consent
- Signed informed consent form from patient
- Participation in a parallel clinical trial is allowed in this non-interventional study
Who cannot join
- Inability to give informed consent
- Inability to adhere to recommended follow-up according to the treating physician
- Vulnerable participants will not be included.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Barbara O'Brien, 832-837-9347, BJOBrien@mdanderson.org
Netherlands1 site, 1 recruiting
- Recruiting
Netherlands Cancer Institute
Amsterdam
Dieta Bransdma, +31 (0)20 512 9111, d.brandsma@nki.nl
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich
Emilie Le Rhun, +41 44 255 38 99, emilie.lerhun@usz.ch
About this study
The goal of this project is to develop and validate a reproducible scorecard for the neurological assessment of patients with leptomeningeal metastases that can be used in clinical trials including such patients, as well as in clinical practice.
- Conditions
- Leptomeningeal Metastasis, Leptomeningeal Disease, Leptomeningeal Neoplasms, Leptomeningeal Cancer
- Being tested
- Neurological Assessment
- Medical subject headings
- Meningeal Carcinomatosis, Meningeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological AssessmentOther
Clinical neurological assessment performed by 2 raters
What is being measured
The primary outcome is the main question the study is designed to answer.
inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters
Measured: December 2026
Secondary outcomes (5)
inter-observer reproducibility (agreement) for each item - per center and among all raters
Measured: December 2026
association between items
Measured: December 2026
variability of the interobserver agreement
Measured: December 2026
description of clinical neurological symptoms and signs
Measured: December 2026
association of clinical response with imaging and CSF cytology response and the overall global clinical/MRI/CSF response
Measured: December 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start30 Jan 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leptomeningeal MetastasisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, The Netherlands Cancer Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417710
- Sponsor's protocol ID
- NANO-LM-01
- Acronym
- NANO-LM
- Status last verified
- May 2024
- First submitted
- 12 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Le Rhun E, Nayak L, Lim-Fat MJ, Ruda R, Pentsova E, Forsyth P, O'Brien BJ, Preusser M, Kumthekar P, Brandsma D, Weller M. NANO-LM: An updated scorecard for the clinical assessment of patients with leptomeningeal metastases. Neuro Oncol. 2025 Feb 10;27(2):455-465. doi: 10.1093/neuonc/noae171.
PubMed 39208403
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis
- ClinicalTrials.gov ID
- NCT06417710
- Acronym / sponsor ID
- NANO-LM / NANO-LM-01
- Conditions
- Leptomeningeal Metastasis, Leptomeningeal Disease, Leptomeningeal Neoplasms, Leptomeningeal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, The Netherlands Cancer Institute
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to develop and validate a reproducible scorecard for the neurological assessment of patients with leptomeningeal metastases that can be used in clinical trials including such patients, as well as in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with leptomeningeal metastases from various extra-central nervous system (CNS) solid primary tumors for whom a tumor-specific treatment is planned
Key inclusion criteria (7 listed)
- Adult patients (18 years or more), female or male
- Histologically confirmed diagnosis of extra-CNS primary solid cancer
- Diagnosis of leptomeningeal metastases confirmed or probable per EANO ESMO criteria
- Performance status compatible with enrolment into clinical trials
- Ability to consent
Key exclusion criteria (3 listed)
- Inability to give informed consent
- Inability to adhere to recommended follow-up according to the treating physician
- Vulnerable participants will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurological AssessmentClinical neurological assessment performed by 2 raters | Other | – |
Primary outcome
inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters
Time frame: December 2026
5 secondary outcomes
inter-observer reproducibility (agreement) for each item - per center and among all raters
Time frame: December 2026
association between items
Time frame: December 2026
variability of the interobserver agreement
Time frame: December 2026
description of clinical neurological symptoms and signs
Time frame: December 2026
association of clinical response with imaging and CSF cytology response and the overall global clinical/MRI/CSF response
Time frame: December 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 39208403Le Rhun E, Nayak L, Lim-Fat MJ, Ruda R, Pentsova E, Forsyth P, O'Brien BJ, Preusser M, Kumthekar P, Brandsma D, Weller M. NANO-LM: An updated scorecard for the clinical assessment of patients with leptomeningeal metastases. Neuro Oncol. 2025 Feb 10;27(2):455-465. doi: 10.1093/neuonc/noae171.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leptomeningeal Metastasis and Leptomeningeal Disease, run by University of Zurich at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters (time frame: December 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06417710, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.