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

This study has been terminated.
(One participant enrolled, study terminated .)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00477503
First received: May 21, 2007
Last updated: July 31, 2012
Last verified: July 2012
  Purpose
  • 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 Intervention Phase
Central Nervous System Tumors
Brain Tumors
Drug: Gallium-67 Citrate (Ga-67)
Drug: In-111 DTPA (In-111 pentetate)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: May 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00477503     History of Changes
Other Study ID Numbers: 2006-0623
Study First Received: May 21, 2007
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

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:
Brain Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pentetic Acid
Citric Acid
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antidotes
Protective Agents
Physiological Effects of Drugs
Iron Chelating Agents
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014