Know Cancer

or
forgot password

PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404


N/A
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma Multiforme, Brain Metastases

Thank you

Trial Information

PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404


Inclusion Criteria:



- Participants will have a contrast enhanced brain MRI which documents
evidence of primary or metastatic brain tumor or suspected tumor recurrence after
therapy

- Tumor size at least 1.5 cm in greatest axial dimension on MRI. MRI must be obtained
within 2 months of study inclusion

- Adult patients 18 or older

- Female patients must not be pregnant or breast feeding and both women of childbearing
potential, and men, must use appropriate means of contraception and must be
maintained for at least 45 days after injection of 124I-NM404 Participants must not
attempt to become pregnant during this time

- Platelet count must be ≥ 160,000/µl, Hematocrit must be ≥ 22%, Leukocyte count must
be ≥ 3,000/µL, Creatinine must be ≤ 2.5 mg/dL, ALT must be ≤ 130 U/L, AST must be ≤
100 U/L, and urine or serum pregnancy test must be negative for pregnancy

- Patient provides informed consent

- Karnofsky score ≥ 60

- For previously treated brain tumors, targeted brain therapy (radiation or drug) must
have concluded ≥2 months prior to injection of 124I-NM404

Exclusion Criteria:

- Life expectancy of < 3 months

- Allergy to potassium iodide (SSKI or Thyroshield)

- Unwilling or unable to complete 3 separate PET/CT imaging sessions of 90 minutes each
over 3 days

- Pregnancy or breast-feeding during time of study and/or anticipated breast feeding at
any time for 45 days after injection of 124I-NM404.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

tumor-to-background ratios

Outcome Description:

imaging will be performed at 6hrs, 24hrs and 48 hrs post injection

Outcome Time Frame:

48hrs

Safety Issue:

No

Principal Investigator

Lance Hall, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin Hospital and Clinics

Authority:

United States: Food and Drug Administration

Study ID:

RO11360

NCT ID:

NCT01540513

Start Date:

March 2012

Completion Date:

June 2014

Related Keywords:

  • Glioblastoma Multiforme
  • Brain Metastases
  • Brain Neoplasms
  • Glioblastoma
  • Neoplasm Metastasis

Name

Location

University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001