Brain Metastases, Glioblastoma Multiforme
Conditions
Brief summary
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
Interventions
DRUGNM404
injection of 5.0mCi I-124 NM404 Arms: I124-NM404 brain metastases or GBM imaging Other Names: PET imaging with I-124 NM404
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor to Background Ratios (TBR) Post-imaging for All Lesions With PET Uptake | 24- and 48 hours post injection | TBR is calculated by using tumor/lesion SUVmax and dividing by contralateral normal brain background SUVmean value. Imaging performed at 24- and 48 hours post injection. |
| Tumor to Background Ratios (TBR) Post-imaging for Confirmed Malignant Tumors | 24- and 48 hours post injection | TBR is calculated by using tumor/lesion SUVmax and dividing by contralateral normal brain background SUVmean value. Imaging performed at 24-, and 48 hours post injection. |
| Tumor to Blood Pool Ratios Post-imaging for All Lesions With PET Uptake | 24- and 48 hours post injection | Tumor to blood pool ratio (tumor SUVmax to superior sinus SUVmean) was calculated at each time point. Tumor to blood pool is calculated by using tumor/lesion SUVmax and dividing by blood pool SUVmean from placing a region of interest in the posterior sagittal sinus near the confluence of sinuses. Imaging performed at 24- and 48 hours post injection. |
| Tumor to Blood Pool Ratios Post-imaging for Confirmed Malignant Tumors | 24- and 48 hours post injection | Tumor to blood pool ratio (tumor SUVmax to superior sinus SUVmean) was calculated at each time point. Tumor to blood pool is calculated by using tumor/lesion SUVmax and dividing by blood pool SUVmean from placing a region of interest in the posterior sagittal sinus near the confluence of sinuses. Imaging performed at 24-, and 48 hours post injection. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from March 2012 to September 2014 at the University of Wisconsin Hospital and Clinics.
Participants by arm
| Arm | Count |
|---|---|
| I124-NM404 Brain Metastases or GBM Imaging Participants injected with 185 MBq ± of 124I-CLR1404 intravenously over a period of 1 to 2 minutes, followed by a flush of 10 mL of normal saline. Subjects returned for PET/CT imaging at 6-, 24-, and 48-hours post-injection.
Participants received 3 drops of potassium iodide by mouth (1 gm/ml) 1 to 24 hours prior to injection of 124I-CLR1404 and continued additional daily doses prior to each PET/CT scan for 3 consecutive days. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | I124-NM404 Brain Metastases or GBM Imaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 43.9 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Tumor to Background Ratios (TBR) Post-imaging for All Lesions With PET Uptake
TBR is calculated by using tumor/lesion SUVmax and dividing by contralateral normal brain background SUVmean value. Imaging performed at 24- and 48 hours post injection.
Time frame: 24- and 48 hours post injection
Population: Of 12 subjects, only 8 had evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| I124-NM404 Brain Metastases or GBM Imaging | Tumor to Background Ratios (TBR) Post-imaging for All Lesions With PET Uptake | 48 hours | 8.75 Ratio of PET SUV | Standard Deviation 3.6 |
| I124-NM404 Brain Metastases or GBM Imaging | Tumor to Background Ratios (TBR) Post-imaging for All Lesions With PET Uptake | 24 hours | 8.25 Ratio of PET SUV | Standard Deviation 4.16 |
Primary
Tumor to Background Ratios (TBR) Post-imaging for Confirmed Malignant Tumors
TBR is calculated by using tumor/lesion SUVmax and dividing by contralateral normal brain background SUVmean value. Imaging performed at 24-, and 48 hours post injection.
Time frame: 24- and 48 hours post injection
Population: Of 12 participants, 8 had evaluable TBR data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| I124-NM404 Brain Metastases or GBM Imaging | Tumor to Background Ratios (TBR) Post-imaging for Confirmed Malignant Tumors | 24 hours | 9.32 Ratio of PET SUV | Standard Deviation 4.33 |
| I124-NM404 Brain Metastases or GBM Imaging | Tumor to Background Ratios (TBR) Post-imaging for Confirmed Malignant Tumors | 48 hours | 10.04 Ratio of PET SUV | Standard Deviation 3.15 |
Primary
Tumor to Blood Pool Ratios Post-imaging for All Lesions With PET Uptake
Tumor to blood pool ratio (tumor SUVmax to superior sinus SUVmean) was calculated at each time point. Tumor to blood pool is calculated by using tumor/lesion SUVmax and dividing by blood pool SUVmean from placing a region of interest in the posterior sagittal sinus near the confluence of sinuses. Imaging performed at 24- and 48 hours post injection.
Time frame: 24- and 48 hours post injection
Population: Of 12 participants, 8 had evaluable TBR data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| I124-NM404 Brain Metastases or GBM Imaging | Tumor to Blood Pool Ratios Post-imaging for All Lesions With PET Uptake | 24 hours | 2.86 Ratio of PET SUV | Standard Deviation 1.77 |
| I124-NM404 Brain Metastases or GBM Imaging | Tumor to Blood Pool Ratios Post-imaging for All Lesions With PET Uptake | 48 hours | 2.93 Ratio of PET SUV | Standard Deviation 2.07 |
Primary
Tumor to Blood Pool Ratios Post-imaging for Confirmed Malignant Tumors
Tumor to blood pool ratio (tumor SUVmax to superior sinus SUVmean) was calculated at each time point. Tumor to blood pool is calculated by using tumor/lesion SUVmax and dividing by blood pool SUVmean from placing a region of interest in the posterior sagittal sinus near the confluence of sinuses. Imaging performed at 24-, and 48 hours post injection.
Time frame: 24- and 48 hours post injection
Population: Of 12 participants, 8 had evaluable tumor to blood pool ratio data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| I124-NM404 Brain Metastases or GBM Imaging | Tumor to Blood Pool Ratios Post-imaging for Confirmed Malignant Tumors | 24 hours | 3.35 Ratio of PET SUV | Standard Deviation 1.75 |
| I124-NM404 Brain Metastases or GBM Imaging | Tumor to Blood Pool Ratios Post-imaging for Confirmed Malignant Tumors | 48 hours | 3.45 Ratio of PET SUV | Standard Deviation 2.15 |