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

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ClinicalTrials.gov Identifier: NCT00477503
Recruitment Status : Terminated (One participant enrolled, study terminated .)
First Posted : May 23, 2007
Last Update Posted : August 1, 2012
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Central Nervous System Tumors Brain Tumors Drug: Gallium-67 Citrate (Ga-67) Drug: In-111 DTPA (In-111 pentetate) Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA
Study Start Date : May 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

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U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Group A
Ga-67 citrate injection alone for individuals with cancer cells in cerebral spinal fluid (CSF), no earlier treatment for disease.
Drug: Gallium-67 Citrate (Ga-67)

Group A: Ga-67 citrate injection alone, in the baseline study.

Group B: Ga-67 and In 111 DTPA injection in the baseline study.

Group C: Standard of care with Ga-67 and In 111 DTPA injection in baseline study.

Active Comparator: Group B
Ga-67 + In 111 DTPA injection for individuals who have cancer cells in CSF, no earlier treatment for disease.
Drug: Gallium-67 Citrate (Ga-67)

Group A: Ga-67 citrate injection alone, in the baseline study.

Group B: Ga-67 and In 111 DTPA injection in the baseline study.

Group C: Standard of care with Ga-67 and In 111 DTPA injection in baseline study.

Drug: In-111 DTPA (In-111 pentetate)

Group B: Ga-67 and In 111 DTPA injection in the baseline study.

Group C: Standard of care with Ga-67 and In 111 DTPA injection in baseline study.

Other Name: DTPA
Active Comparator: Group C
Individuals with tumors in the CSF that have been treated and are now cleared from the CSF, receive standard follow-up care (baseline injection of Ga-67 citrate and In-111 DTPA).
Drug: Gallium-67 Citrate (Ga-67)

Group A: Ga-67 citrate injection alone, in the baseline study.

Group B: Ga-67 and In 111 DTPA injection in the baseline study.

Group C: Standard of care with Ga-67 and In 111 DTPA injection in baseline study.

Drug: In-111 DTPA (In-111 pentetate)

Group B: Ga-67 and In 111 DTPA injection in the baseline study.

Group C: Standard of care with Ga-67 and In 111 DTPA injection in baseline study.

Other Name: DTPA



Primary Outcome Measures :
  1. 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. [ Time Frame: 3 years ]


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477503


Locations
United States, Texas
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Franklin C Wong, M.D. M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00477503     History of Changes
Other Study ID Numbers: 2006-0623
First Posted: May 23, 2007    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Central Nervous System Tumors
Brain Tumors
Leptomeningeal Metastasis
Cerebral Spinal Fluid
Human CSF Flow
Nuclear Imaging
Gallium-67 Citrate
In-111 DTPA

Additional relevant MeSH terms:
Neoplasms
Brain Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Citric Acid
Edetic Acid
Pentetic Acid
Gallium citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antidotes
Protective Agents
Physiological Effects of Drugs
Iron Chelating Agents
Radiopharmaceuticals