Clinical Trials Logo
  1. Home
  2. Leptomeningeal Metastasis
  3. NCT06417710
  4. Details
NCT06417710 Clinical Trial

Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis

Leptomeningeal Metastasis Clinical Trial

— NANO-LM  

Official title:
Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06417710
Other study ID # NANO-LM-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 30, 2022
Est. completion date December 2026

Study information
Verified date May 2024
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Inability to give informed consent - Inability to adhere to recommended follow-up according to the treating physician Vulnerable participants will not be included.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Neurological Assessment
Clinical neurological assessment performed by 2 raters

Locations
Country Name City State
Netherlands Netherlands Cancer Institute Amsterdam
Switzerland University Hospital Zurich Zurich
United States MD Anderson Cancer Center Houston Texas

Sponsors (3)
Lead Sponsor Collaborator
University of Zurich M.D. Anderson Cancer Center, The Netherlands Cancer Institute

Countries where clinical trial is conducted

United States,  Netherlands,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters December 2026
Secondary inter-observer reproducibility (agreement) for each item - per center and among all raters December 2026
Secondary association between items December 2026
Secondary variability of the interobserver agreement December 2026
Secondary description of clinical neurological symptoms and signs December 2026
Secondary association of clinical response with imaging and CSF cytology response and the overall global clinical/MRI/CSF response December 2026
See also
  Status Clinical Trial Phase
Terminated NCT05414123 - A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
Recruiting NCT06058988 - Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer Phase 2
Completed NCT04178343 - Tomotherapy for Leptomeningeal Metastases N/A
Recruiting NCT06399926 - Efficacy and Safety of Intraventricule Pemetrexed Disodium Administered Via Ommaya Reservoir
Not yet recruiting NCT06441045 - Double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed Versus Double Dose of Third-generation EGFR-TKI in Patients With LM Progression Following the Treatment of Routine Dose of Third-generation EGFR-TKI Phase 2
Recruiting NCT04425681 - Osimertinib With Bevacizumab for Leptomeningeal Metastasis From EGFR-mutation Non-Small Cell Lung Cancer Phase 2
Recruiting NCT05598853 - Intrathecal Double Checkpoint Inhibition Phase 1
Recruiting NCT02803619 - A Multi-center Prospective Observational Biomarker Study on EGFRm+ Non-small Cell Lung Cancer Patients With Leptomeningeal Metastasis N/A
Recruiting NCT05746754 - Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis N/A
Not yet recruiting NCT04148898 - Osimertinib With or Without Bevacizumab for EGFR- Mutant Non-small Cell Lung Cancer With Leptomeningeal Metastasis Phase 2
Completed NCT04420598 - DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease Phase 2
Completed NCT02071056 - Circulating Tumor DNA in Cerebrospinal Fluid as an Early Biomarker of Leptomeningeal Metastasis (LM)
Recruiting NCT05385185 - Clinical Observation of ICI Combined With Recombinant Human Endostatin on Leptomeningeal Metastasis of Lung Cancer Phase 2
Terminated NCT04729348 - Pembrolizumab And Lenvatinib In Leptomeningeal Metastases Phase 2
Recruiting NCT06304441 - Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs (e.g. 'Osimertinib') Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis From Epidermal Growth Factor Receptor Mutation-Positive Non-Small-cell Lung Cancer N/A
Not yet recruiting NCT06296745 - Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib. Phase 2
Recruiting NCT04778800 - A Dose Exploration Study of Almonertinib for EGFRm NSCLC Patients With Brain/Leptomeningeal Metastasis (ARTISTRY) N/A
Not yet recruiting NCT06282874 - Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases Phase 4
Not yet recruiting NCT04356118 - Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis Phase 4
Not yet recruiting NCT04356222 - Efficacy and Safety of Durvalumab in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis Phase 4