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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

Tracking Information
First Submitted Date  ICMJE May 21, 2007
First Posted Date  ICMJE May 23, 2007
Last Update Posted Date August 1, 2012
Study Start Date  ICMJE May 2007
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA
Official Title  ICMJE Phase 1 Study Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA
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.
Detailed Description

In-111 DTPA is a radioactive dye that is standardly used to check the flow of CSF. Ga-67 citrate has been used to detect inflammation and tumors in other parts of the body, and researchers want to learn if it is also able to detect tumors in the brain and spinal cord.

Before you can be enrolled in this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Blood (about 1-2 tablespoons) will be drawn for routine tests. This routine blood draw will include a pregnancy test for women who are able to have children. To be eligible to take part in this study, the pregnancy test must be negative.

If you are found to be eligible to take part in this study, you will be assigned to 1 of 3 groups. The group you are assigned to will depend on whether tumor cells were found in the CSF during your last spinal fluid exam. If you were found to have cancer cells in the CSF and you have had no earlier treatment for this type of disease, the first 5 participants will be assigned to Group A and will be given Ga-67 citrate injection alone, in the baseline study. The next 5 participants who have cancer cells in the CSF and have had no earlier treatment will be assigned to Group B. Group B will have Ga-67 and In 111 DTPA injection in the baseline study. Otherwise, if the tumors in the CSF have been treated and are now cleared from the CSF, you will be assigned to Group C and will receive standard follow-up care.

At the beginning of the study, you will have an imaging session. This first imaging session is called the "baseline" session. For the imaging, you will lie on a gamma camera table. Depending on which group you are in, one or both of the radioactive dyes will be injected into your CSF through the Ommaya reservoir. If you are in Group B or C, both In-111 DTPA and Ga-67 citrate will be injected over about 2-4 minutes, total. If you are in Group A, Ga-67 citrate alone will be injected over about 2 minutes.

For participants who are 2-17 years old, the doses of In-111 DTPA and Ga-67 citrate will be adjusted to the surface area of your body (a measurement of your body size).

During the hour immediately following the injections, your head, neck, and back areas will be imaged (scanned) in order to see how the CSF flows. After that, you will have scans of your entire body performed in order to see how quickly the radioactive dyes leave from different parts of your body. These whole-body scans will each last 20 minutes. These scans (1 each time) will occur at 1-2, 3-4, 6-8, 22-24, 28-32, 48, and 72 hours after the injections. You will have blood samples collected before injection and during each imaging session in order to measure how much radiation is absorbed by different parts of your brain, spine, and other organs. These blood samples (less than ¼ teaspoon each time) will be drawn during each of the whole-body scans.

If you are in Group A or B, you will receive standard follow-up care for up to 52 weeks after the baseline imaging session. This is in order to check the status of the disease. If the cancer goes into remission (no tumor cells are found in CSF) at any time during the 52 weeks, you will have a follow-up imaging session. The follow-up imaging session will include the same procedures, and In-111 DTPA and/or Ga-67 citrate injections as the baseline imaging session.

If you are in Group C, you will receive standard follow-up care for up to 52 weeks after the baseline imaging session. If the cancer reappears at any time during the 52 weeks, you will have a follow-up imaging session. The follow-up imaging session will include the same procedures, and In-111 DTPA and Ga-67 citrate injections as the baseline imaging session.

Whether you are in Group A, B or C, after your last follow-up imaging session, your participation in this study will be over. If your cancer clears from the spinal fluid, the records from your routine visit to the neuro-oncology clinic will be reviewed to follow your progress until 30 days after the radioisotope injection for your last imaging session. Researchers will review your medical records for potential side effects. If you do not have a clinical visit within a week from that 30th day, the study chair will contact you by phone concerning these matters.

This is an investigational study. In-111 DTPA is commercially available and FDA approved for injection into the CSF. Although Ga-67 citrate is FDA approved for injection into a vein, it is not FDA approved for injection into the CSF. It is commercially available, but injecting it into the CSF has only been authorized for use in research. Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Central Nervous System Tumors
  • Brain Tumors
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Group A
    Ga-67 citrate injection alone for individuals with cancer cells in cerebral spinal fluid (CSF), no earlier treatment for disease.
    Intervention: Drug: Gallium-67 Citrate (Ga-67)
  • Active Comparator: Group B
    Ga-67 + In 111 DTPA injection for individuals who have cancer cells in CSF, no earlier treatment for disease.
    Interventions:
    • Drug: Gallium-67 Citrate (Ga-67)
    • Drug: In-111 DTPA (In-111 pentetate)
  • 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).
    Interventions:
    • Drug: Gallium-67 Citrate (Ga-67)
    • Drug: In-111 DTPA (In-111 pentetate)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 10, 2009)
1
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2007)
20
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00477503
Other Study ID Numbers  ICMJE 2006-0623
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Franklin C Wong, M.D. M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP