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

• Status: Terminated
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Citric Acid; Edetic Acid; Gallium citrate; Pentetic Acid

Criteria

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, as established by medical records or claimed by patient.