PET/CT Imaging of Malignant Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue 124I-NM404
This study is currently recruiting participants.
Verified November 2012 by University of Wisconsin, Madison
Sponsor:
University of Wisconsin, Madison
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01516905
First received: January 10, 2012
Last updated: November 27, 2012
Last verified: November 2012
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Purpose
The purpose of this study is to evaluate diagnostic imaging techniques using 124I-NM404 PET/CT in humans with brain metastases and GBMs. This goal will be accomplished by determining the optimal PET/CT protocol and comparing PET tumor uptake to MRI and calculating tumor dosimetry. A future aim of this study will be to compare non-invasive PET/CT and MRI findings with pathological specimens, which is the gold standard but is invasive and impractical in many cases, to determine the sensitivity and specificity of both techniques for accurately detecting tumor infiltration. The data obtained from this study will be used to develop larger diagnostic and therapeutic trials in brain tumors. The long-term goals of this research are to improve the diagnosis and treatment of malignant brain tumors by using radioiodinated NM404.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma Brain Metastases |
Drug: NM404 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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 ]patients will be imaged at 3 different times out to 48 hrs post injection. Images will be evaluated based on tumor/background, dimensions/volumes and a qualitative score
| Estimated Enrollment: | 25 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | January 2017 |
| Estimated Primary Completion Date: | January 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: I124-NM404 brain metastases or GBM imaging
determining appropriate imaging timepoints. Image at 6 hour, 24 hour and 48 hour post injection of I-124NM404
|
Drug: NM404
injection of either 2.0mCi or 5.0mCi I-124 NM404
Other Name: PET imaging with I-124 NM404
|
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 GBM or metastatic brain tumor
- Tumor size at least 1.5 cm in greatest axial dimension on MRI. MRI must be obtained within 2 months of study inclusion
- 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 I-124 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
- Karnofsky score ≥ 60
- For brain metastases patients: targeted brain therapy (radiation or drug) must have concluded ≥2 months prior to injection of 124I-NM404
- For GBM tumors confirmed by surgical biopsy or suspected by MRI: no previous surgical resection (except for biopsy) or systemic or radiation therapy targeted to the GBM tumor -
Exclusion Criteria:
- Life expectancy of < 3 months
- Allergy to potassium iodide (SSKI or Thyroshield)
- Planned surgical resection or biopsy after injection of 124I-NM404 and prior to completion of the 3rd PET/CT scan
- Unwilling or unable to complete 3 separate PET/CT imaging sessions of 90 minutes each over 3 days -
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516905
Contacts
| Contact: Diana D Trask, BS | 608-263-9528 | datrask@humonc.wisc.edu |
Locations
| United States, Wisconsin | |
| University of Wisconsin Hospital and Clinics | Recruiting |
| Madison, Wisconsin, United States, 53792 | |
| Contact: Diana D Trask, BS 608-263-9528 trask@humonc.wisc.edu | |
| 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: | NCT01516905 History of Changes |
| Other Study ID Numbers: | RO11310, 1R01CA158800-01 |
| Study First Received: | January 10, 2012 |
| Last Updated: | November 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Glioblastoma Neoplasm Metastasis Brain Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplastic Processes Pathologic Processes Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013