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

Stopped early · Phase 1

Conditions studied: Central Nervous System Tumors, Brain Tumors

In brief

* 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.

Key facts

Study ID

NCT00477503

Run by

M.D. Anderson Cancer Center

People needed

1

Starts

2007-05-01

Expected to finish

2009-07-01

Last updated by the study team

2012-08-01

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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, as established by medical records or claimed by patient.

Where it is running

• The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.