TerminatedPhase 1

Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA

Stopped: One participant enrolled, study terminated .

United States1 participantsStarted 2007-05

Plain-language summary

* Primary Objective will be to evaluate the use of Ga-67 citrate as an alternative radiopharmaceutical for CSF imaging. * Secondary Objective will be to evaluate the biodistribution, pharmacokinetics and radiation dosimetry of In 111 DTPA and gallium-67 after intrathecal injection during remission of leptomeningeal metastasis (LM) and during LM occurrence, remission and recurrence.

Who can participate

Age range

2 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: * Participants must have provided informed consent. * Participants must be 2 years of age or older. * Participants must have known history of LM as established by CSF cytology. * Participants must have an Ommaya reservoir implanted at least 2 days before the study. * Participants with ventriculoperitoneal shunts are eligible as long as the shunt is not in the "open" position during the imaging session. * Participants with adequate renal and hepatic function. Creatinine =\< 1.4 mg/dL Bilirubin =\< 2.0 mg/dL BUN =\< 30 SGOT (AST), alkaline phosphatase =\<3 x upper norm (Institutional norm of SGOT = 7-56 mIU/ml and alkaline phosphatase = 38-126 IU/L.). * Urine analysis within normal limits. * Women of child bearing potential (WOCBP) must have a negative serum B-HCG pregnancy test within 7 days of treatment. WOCBP is defined as not post-menopausal for 12 months or no previous surgical sterilization. Exclusion Criteria: * Participants on concurrent external beam radiation therapy to the brain or spine during the planned nuclear imaging sessions. * Participants on concurrent intrathecal chemotherapy during imaging sessions. * Participants with Karnofsky Performance Scale \<50 or Zubrod Performance Scale \>2. * Participants with known or suspected renal or hepatic disease that have not been adequately treated to achieve normalized liver function tests or renal function tests to the above eligible criteria. * Participants with known history of claustrophobia, a…

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

To compare Ga-67 citrate with a standard radioactive dye in order to learn if Ga-67 citrate can help doctors to check the flow of CSF for any blockage.

Timeframe: 3 years

Trial details

NCT IDNCT00477503

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-07

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