Trial Outcomes & Findings for Positron Emission Tomography (PET) Imaging Studies With NIS Reporter (NCT NCT02907073)
NCT ID: NCT02907073
Last Updated: 2019-05-17
Results Overview
F-18 BF4 concentrations in major tissues (e.g., heart, blood pool, lung, liver, thyroid, stomach, kidney, brain, muscle) will be evaluated from the PET images from 0-240 minutes post-administration. Results will be used to compute radiation dosimetry estimates.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
0-240 minutes
Results posted on
2019-05-17
Participant Flow
Participant milestones
| Measure |
Healthy Volunteers
At the study visit, healthy subjects will have an initial physical exam, urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration and blood sampling. Vital signs, and blood samples will be obtained. Subjects will receive an infusion \[18F\]BF4 over 1 minute and Positron Emission Tomography (PET) imaging will begin. Three (3) PET/CT scanning procedures will be performed over a period of approximately 4 hours with two rest breaks in between. Venous blood samples for clinical laboratory tests will be taken before radiotracer administration and at 1.5 hours post-administration of radiotracer. In addition, venous blood samples will be taken during the PET/CT scans to determine blood pharmacokinetics and metabolite evaluation. Physical exam will be repeated at the end of the study.
BF4: Single IV dose of 9-11 millicurie (mCi) sodium \[Fluorine-18\] radiolabeled B4\^F
|
Myeloma Patients
For cancer patients undergoing virus treatments, subjects will undergo \[18F\]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of \[18F\]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of \[18F\]BF4 in up to three myeloma patients when the site is accessible for biopsy.
BF4: Single IV dose of 9-11 mCi sodium \[Fluorine-18\] radiolabeled B4\^F
|
Endometrial Cancer Patients
For cancer patients undergoing virus treatments, subjects will undergo \[18F\]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of \[18F\]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of \[18F\]BF4 in up to three endometrial cancer patients when the site is accessible for biopsy.
BF4: Single IV dose of 9-11 mCi sodium \[Fluorine-18\] radiolabeled B4\^F
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
0
|
0
|
|
Overall Study
COMPLETED
|
8
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Positron Emission Tomography (PET) Imaging Studies With NIS Reporter
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=8 Participants
At the study visit, healthy subjects will have an initial physical exam, urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration and blood sampling. Vital signs, and blood samples will be obtained. Subjects will receive an infusion \[18F\]BF4 over 1 minute and PET imaging will begin. Three (3) PET/CT scanning procedures will be performed over a period of approximately 4 hours with two rest breaks in between. Venous blood samples for clinical laboratory tests will be taken before radiotracer administration and at 1.5 hours post-administration of radiotracer. In addition, venous blood samples will be taken during the PET/CT scans to determine blood pharmacokinetics and metabolite evaluation. Physical exam will be repeated at the end of the study.
BF4: Single IV dose of 9-11 mCi sodium \[Fluorine-18\] radiolabeled B4\^F
|
Myeloma Patients
For cancer patients undergoing virus treatments, subjects will undergo \[18F\]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of \[18F\]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of \[18F\]BF4 in up to three myeloma patients when the site is accessible for biopsy.
BF4: Single IV dose of 9-11 mCi sodium \[Fluorine-18\] radiolabeled B4\^F
|
Endometrial Cancer Patients
For cancer patients undergoing virus treatments, subjects will undergo \[18F\]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of \[18F\]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of \[18F\]BF4 in up to three endometrial cancer patients when the site is accessible for biopsy.
BF4: Single IV dose of 9-11 mCi sodium \[Fluorine-18\] radiolabeled B4\^F
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 11 • n=5 Participants
|
—
|
—
|
35 years
STANDARD_DEVIATION 11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
—
|
—
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
—
|
—
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
—
|
—
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
—
|
—
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
—
|
—
|
8 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0-240 minutesPopulation: Outcome measures were performed in study arm of eight healthy volunteers. F or the myeloma and endometrial cancer arms of the study, the study was terminated due to pursuing Investigational New Drug application (IND).
F-18 BF4 concentrations in major tissues (e.g., heart, blood pool, lung, liver, thyroid, stomach, kidney, brain, muscle) will be evaluated from the PET images from 0-240 minutes post-administration. Results will be used to compute radiation dosimetry estimates.
Outcome measures
| Measure |
Healthy Volunteers
n=8 Participants
At the study visit, healthy subjects will have an initial physical exam, urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration and blood sampling. Vital signs, and blood samples will be obtained. Subjects will receive an infusion \[18F\]BF4 over 1 minute and PET imaging will begin. Three (3) PET/CT scanning procedures will be performed over a period of approximately 4 hours with two rest breaks in between. Venous blood samples for clinical laboratory tests will be taken before radiotracer administration and at 1.5 hours post-administration of radiotracer. In addition, venous blood samples will be taken during the PET/CT scans to determine blood pharmacokinetics and metabolite evaluation. Physical exam will be repeated at the end of the study.
BF4: Single IV dose of 9-11 mCi sodium \[Fluorine-18\] radiolabeled B4\^F
|
Myeloma Patients
For cancer patients undergoing virus treatments, subjects will undergo \[18F\]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of \[18F\]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of \[18F\]BF4 in up to three myeloma patients when the site is accessible for biopsy.
BF4: Single IV dose of 9-11 mCi sodium \[Fluorine-18\] radiolabeled B4\^F
|
Endometrial Cancer Patients
For cancer patients undergoing virus treatments, subjects will undergo \[18F\]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of \[18F\]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of \[18F\]BF4 in up to three endometrial cancer patients when the site is accessible for biopsy.
BF4: Single IV dose of 9-11 mCi sodium \[Fluorine-18\] radiolabeled B4\^F
|
|---|---|---|---|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Muscle uptake - 2h males
|
0.71 standardized uptake value (SUV)
Standard Deviation 0.31
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Muscle uptake - 2h females
|
0.65 standardized uptake value (SUV)
Standard Deviation 0.35
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Myocardium - 2h males
|
3.2 standardized uptake value (SUV)
Standard Deviation 0.9
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
yocardium - 2h females
|
2.8 standardized uptake value (SUV)
Standard Deviation 0.5
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Pancreas - 2h males
|
3.4 standardized uptake value (SUV)
Standard Deviation 0.7
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Pancreas - 2h females
|
3.1 standardized uptake value (SUV)
Standard Deviation 1.7
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Parotid gland - 2h males
|
11 standardized uptake value (SUV)
Standard Deviation 9
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Parotid gland - 2h females
|
20 standardized uptake value (SUV)
Standard Deviation 11
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Spleen - 2h males
|
4.1 standardized uptake value (SUV)
Standard Deviation 1.2
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Spleen - 2h females
|
4.3 standardized uptake value (SUV)
Standard Deviation 1.0
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Stomach - 2h males
|
33 standardized uptake value (SUV)
Standard Deviation 15
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Stomach - 2h females
|
72 standardized uptake value (SUV)
Standard Deviation 10
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Thyroid - 2h males
|
55 standardized uptake value (SUV)
Standard Deviation 31
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Thyroid - 2h females
|
50 standardized uptake value (SUV)
Standard Deviation 11
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Bone uptake - 2 h males
|
0.8 standardized uptake value (SUV)
Standard Deviation 0.39
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Bone uptake - 2 h females
|
1.4 standardized uptake value (SUV)
Standard Deviation 0.5
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Brain uptake - 2 h males
|
0.39 standardized uptake value (SUV)
Standard Deviation 0.14
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Brain uptake - 2 h females
|
0.42 standardized uptake value (SUV)
Standard Deviation 0.15
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Breast uptake - 2 h females
|
2.8 standardized uptake value (SUV)
Standard Deviation 0.4
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Gallbladder uptake - 2 h males
|
2.7 standardized uptake value (SUV)
Standard Deviation 1.5
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Gallbladder uptake - 2h females
|
3.7 standardized uptake value (SUV)
Standard Deviation 1.0
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Intestinal uptake - 2h males
|
2.9 standardized uptake value (SUV)
Standard Deviation 1.0
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Intestinal uptake - 2h females
|
5.0 standardized uptake value (SUV)
Standard Deviation 2.7
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Kidney uptake - 2h males
|
7.0 standardized uptake value (SUV)
Standard Deviation 2.5
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Kidney uptake - 2h females
|
5.6 standardized uptake value (SUV)
Standard Deviation 0.7
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Liver uptake - 2h males
|
2.3 standardized uptake value (SUV)
Standard Deviation 1.0
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Liver uptake - 2h females
|
2.7 standardized uptake value (SUV)
Standard Deviation 0.5
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Lung uptake - 2h males
|
1.0 standardized uptake value (SUV)
Standard Deviation 0.4
|
—
|
—
|
|
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Lung uptake - 2h females
|
1.2 standardized uptake value (SUV)
Standard Deviation 0.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 9Population: Healthy volunteers do not have tumors. The study in myeloma and endometrial cancer was terminated due to pursuing IND.
Areas of positive uptake within tumor, relative to background, measured by Standardized Update Value (SUV). PET SUV is tissue concentration/injected dose/body weight in grams.
Outcome measures
Outcome data not reported
Adverse Events
Healthy Volunteers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Myeloma Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Endometrial Cancer Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place