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New treatment option for Leptomeningeal Metastasis
Official title Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
ClinicalTrials.gov ID: NCT05746754
What this study is testing
- What it's testing
- Leptomeningeal metastasis is a rare but serious complication to cancer, with a grave prognosis. No efficient treatment exists.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Metastasis to the leptomeningeal space (LM) surrounding the brain and/ or spinal cord
- Metastasis verified by MRI or CSF cytology
- Karnofsky \>=60 (requiring some help, can take care of most personal requirements)
- Adequate bone marrow function
- Haemoglobin \> 5 mmol/l
You likely can't join if
- Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances (Yang)
- Patient with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy
- Patient with extensive systemic disease and without reasonable systemic treatment options
- Patient who is unable to undergo MRI brain and spine with gadolinium contrast
- Pregnant or lactating women.
See the full eligibility criteria
- Metastasis to the leptomeningeal space (LM) surrounding the brain and/ or spinal cord
- Metastasis verified by MRI or CSF cytology
- Karnofsky \>=60 (requiring some help, can take care of most personal requirements)
- Adequate bone marrow function
- Haemoglobin \> 5 mmol/l
- Absolute neutrophil count \>1 10\^9/l
- Platelet count \> 100 10\^9/l
- Patient consent
- Female people must either be of non-reproductive potential ( ≥ 60 years old, or with no menses for \>1 year without an alternative medical cause], OR history of hysterectomy, OR history of bilateral tubal ligation, OR...
- Patient at reproductive potential must agree to practice an effective contraceptive method.
- Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances (Yang)
- Patient with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy
- Patient with extensive systemic disease and without reasonable systemic treatment options
- Patient who is unable to undergo MRI brain and spine with gadolinium contrast
- Pregnant or lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Aarhus, Denmark
- Aalborg, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Aarhus, Denmark; Aalborg, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.