PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404
This study is currently recruiting participants.
Verified November 2012 by University of Wisconsin, Madison
Sponsor:
University of Wisconsin, Madison
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01540513
First received: February 14, 2012
Last updated: November 27, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate diagnostic imaging techniques using 124I-NM404 PET/CT in human brain tumors. This goal will be accomplished by quantifying tumor uptake and determining the optimal PET/CT protocol, comparing PET tumor uptake to MRI, and calculating tumor dosimetry. The long-term goals of this research are to improve the diagnosis and treatment of malignant brain tumors by using radioiodinated NM404
| Condition | Intervention |
|---|---|
|
Glioblastoma Multiforme Brain Metastases |
Drug: NM404 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404 |
Resource links provided by NLM:
Further study details as provided by University of Wisconsin, Madison:
Primary Outcome Measures:
- tumor-to-background ratios [ Time Frame: 48hrs ] [ Designated as safety issue: No ]imaging will be performed at 6hrs, 24hrs and 48 hrs post injection
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: I124-NM404 brain metastases or GBM imaging
injection of I-124NM404 for imaging
|
Drug: NM404
injection of 5.0mCi I-124 NM404 Arms: I124-NM404 brain metastases or GBM imaging Other Names: PET imaging with I-124 NM404 injection of an experimental imaging agent, 5mCi I-124NM404
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540513
Contacts
| Contact: Diana Trask, BS | 608-263-9528 | trask@humonc.wisc.edu |
Locations
| United States, Wisconsin | |
| University of Wisconsin Hospital and Clinics | Recruiting |
| Madison, Wisconsin, United States, 53792 | |
| Contact: Diana Trask, BS | |
| Principal Investigator: Lance Hall, MD | |
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
| Principal Investigator: | Lance Hall, MD | University of Wisconsin Hospital and Clinics |
More Information
No publications provided
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT01540513 History of Changes |
| Other Study ID Numbers: | RO11360 |
| Study First Received: | February 14, 2012 |
| Last Updated: | November 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Brain Neoplasms Glioblastoma Neoplasm Metastasis Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013