TerminatedNot Applicable

Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors

Stopped: Study cancelled by PI.

United States2 participantsStarted 2021-08-11

Plain-language summary

Sodium fluorescein, which has been shown to be useful for intraoperative guidance regarding the resection of adult neurosurgical tumors, can aid the resection of pediatric neurosurgical tumors.

Who can participate

Age range

31 Days – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 31 days through 21 years on date of surgery * Undergoing resection of a central nervous system tumor at Children's Hospital Colorado * Parent/legal guardian (or adult subject) willing and able to complete the informed consent process Exclusion Criteria: * Tumor in functionally eloquent cortex that precludes maximal surgical resection * Severe renal dysfunction * Preoperative serum creatinine level \> than normal range and GFR \< 30. * Severe liver dysfunction * History of asthma or pulmonary spasm * Known allergy to sodium fluorescein or any other contrast dye * Previous administration of sodium fluorescein within the last 72 hours * Pregnant or nursing mother * Other unspecified reasons that, in the opinion of the investigator, make the subject unsuitable for enrollment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent of Tumor Resected: Intracranial Lesions

Timeframe: Pre-op assessment to outpatient follow up, up to 6 weeks

Percent of Tumor Resected: Spinal Lesions

Timeframe: Pre-op assessment to outpatient follow up, up to 6 weeks

Trial details

NCT IDNCT03752203

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-29

Results submitted2023-11-17

View on ClinicalTrials.gov More Pediatric Neurosurgical Tumors trials

Who can participate

Age range

31 Days – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.