Brain Tumors Clinical Trial
Official title:
Phase 1 Study Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA
Verified date | July 2012 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
- 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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas M.D. Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 3 years | Yes |
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