Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT00477503
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT00477503
Study Brief:
Protocol Section:
NCT00477503