Optimizing gadopiclenol MRI to detect early leptomeningeal disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to identify the best gadopiclenol dose, scan sequences, and timing to enhance MRI detection of early CNS leptomeningeal disease. It also explores the optimal protocol for detecting parenchymal brain metastases. Brain MRI with gadopiclenol may offer a noninvasive alternative or complement to CSF sampling for LMD detection. The study leverages the agent’s high relaxivity and favorable safety profile to potentially improve sensitivity beyond current MRI approaches. Enrollment targets adults with tissue-confirmed solid malignancies and equivocal LMD on prior imaging or high clinical suspicion with negative CSF and brain MRI results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with tissue confirmed solid malignancy and standard of care brain MRI with equivocal results for LMD (questionable or possible) and negative LP CSF sampling or patients with high risk clinical LMD and negative brain MR and LP CSF sampling. Initially, we will target solid tumors, but if more patients are needed to meet the study power we will enroll liquid tumors.
* Participants \> 18 years of age.
* Participants are able to consent.

Exclusion Criteria:

* Participants with CSF sampling positive for LMD or MR brain/spine with definitive evidence of LMD.
* Participants with implantable devices that can not be scanned with MR safe mode for participant safety.
* Pregnant participants or potentially pregnant participants are at risk of contrast on the fetus

Pediatric participants \< 18 years of age.

Where it's running

• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Rami Eldaya, MD — M.D. Anderson Cancer Center
• Study coordinator: Rami Eldaya, MD
• Email: reldaya@mdanderson.org
• Phone: (713) 745-2945

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.