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

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00477503

Purpose

In vivo study of human cerebral spinal fluid (CSF) flow is important to establish CSF flow patency in the planning of intrathecal cancer treatment. Only one radiopharmaceutical, namely In-111 pentetate (DTPA) (DRAXIMAGE, Inc, Kirkland, Quebec, Canada) is approved by the FDA for human CSF imaging. The supply of this radiopharmaceutical is limited and not always available on short notice.

This is a pilot study using Gallium-67 citrate, another cyclotron product with a physical half-life of 3.3 days and emits gamma rays at 93, 184 and 300 Kev which can be readily imaged for several days. Upon entering the circulation, Ga-67 binds to serum transferrin and then translocates to lactoferrin which is abundant in leukocytes and serve to localize tumor, infectious sources and inflammatory tissues. It may be potentially useful to evaluate spinal fluid flow patency as an alternative to In 111 DTPA. Simultaneous acquisition of nuclear images, of multiple window (photopeaks) allows evaluation of individual radionuclides by a single imaging session, therefore simultaneous imaging of In-111 DTPA and Ga-67 citrate in the same patients will allow comparison of these 2 radiopharmaceuticals during the earlier phase to study the bulk flow and during later phases to evaluate their retention in patients during LM occurrence, LM remission and LM relapse.

Condition	Intervention	Phase
Central Nervous System Tumors Brain Tumors	Drug: Gallium-67 Citrate Drug: In-111 DTPA	Phase I

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors

Drug Information available for: Citric acid Sodium Citrate Gallium Gallium citrate Ga 67

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 1 Study Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA

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

Estimated Enrollment:	20
Study Start Date:	May 2007

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

Study ID Numbers:	2006-0623
Study First Received:	May 21, 2007
Last Updated:	July 26, 2007
ClinicalTrials.gov Identifier:	NCT00477503
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

Study placed in the following topic categories:

Pentetic Acid
Brain Neoplasms
Citric Acid
Neoplasm Metastasis
Central Nervous System Diseases

Central Nervous System Neoplasms
Brain Diseases
Iron
Nervous System Neoplasms

Additional relevant MeSH terms:

Anticoagulants
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Hematologic Agents
Iron Chelating Agents
Protective Agents

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Chelating Agents
Antidotes

ClinicalTrials.gov processed this record on January 16, 2009