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

NCT00477503 | Terminated Phase 1

• 1 other identifier: 2006-0623
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Nervous System Tumors; Brain Tumors

Keywords

Central Nervous System Tumors; Brain Tumors; Leptomeningeal Metastasis; Cerebral Spinal Fluid; Human CSF Flow; Nuclear Imaging; Gallium-67 Citrate; In-111 DTPA

Outcome Measures

Primary Outcomes (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.

  3 years

Study Arms (3)

Group A

ACTIVE COMPARATOR

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 B

ACTIVE COMPARATOR

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

Group C

ACTIVE COMPARATOR

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

Interventions

Gallium-67 Citrate (Ga-67) DRUG

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.

Group A; Group B; Group C

In-111 DTPA (In-111 pentetate) DRUG

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.

Also known as: DTPA

Group B; Group C

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Meningeal Carcinomatosis

Interventions

gallium citrate; Gallium-67; Pentetic Acid

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Meningeal Neoplasms

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Study Officials

• Franklin C Wong, M.D.

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2007
• First Posted: May 23, 2007
• Study Start: May 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

US (1)