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
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.
- 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