Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Positron Emission Tomography (PET) Imaging Studies With NIS Reporter · Source last updated 2019-05-17
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
standardized uptake value (SUV)
Interval / dispersion
Standard Deviation
Time frame
0-240 minutes
What was measured
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.
Analysis population: 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).
Groups in this outcome
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 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
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Healthy Volunteers
8
Myeloma Patients
0
Endometrial Cancer Patients
0
Reported measurements
Bone uptake - 2 h males
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
0.8
0.39
Not reported
Not reported
Not reported
Bone uptake - 2 h females
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
1.4
0.5
Not reported
Not reported
Not reported
Brain uptake - 2 h males
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
0.39
0.14
Not reported
Not reported
Not reported
Brain uptake - 2 h females
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
0.42
0.15
Not reported
Not reported
Not reported
Breast uptake - 2 h females
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
2.8
0.4
Not reported
Not reported
Not reported
Gallbladder uptake - 2 h males
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
2.7
1.5
Not reported
Not reported
Not reported
Gallbladder uptake - 2h females
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
3.7
1.0
Not reported
Not reported
Not reported
Intestinal uptake - 2h males
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
2.9
1.0
Not reported
Not reported
Not reported
Intestinal uptake - 2h females
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
5.0
2.7
Not reported
Not reported
Not reported
Kidney uptake - 2h males
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
7.0
2.5
Not reported
Not reported
Not reported
Kidney uptake - 2h females
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
5.6
0.7
Not reported
Not reported
Not reported
Liver uptake - 2h males
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
2.3
1.0
Not reported
Not reported
Not reported
Liver uptake - 2h females
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
2.7
0.5
Not reported
Not reported
Not reported
Lung uptake - 2h males
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
1.0
0.4
Not reported
Not reported
Not reported
Lung uptake - 2h females
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
1.2
0.4
Not reported
Not reported
Not reported
Muscle uptake - 2h males
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
0.71
0.31
Not reported
Not reported
Not reported
Muscle uptake - 2h females
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
0.65
0.35
Not reported
Not reported
Not reported
Myocardium - 2h males
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
3.2
0.9
Not reported
Not reported
Not reported
yocardium - 2h females
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
2.8
0.5
Not reported
Not reported
Not reported
Pancreas - 2h males
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
3.4
0.7
Not reported
Not reported
Not reported
Pancreas - 2h females
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
3.1
1.7
Not reported
Not reported
Not reported
Parotid gland - 2h males
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
11
9
Not reported
Not reported
Not reported
Parotid gland - 2h females
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
20
11
Not reported
Not reported
Not reported
Spleen - 2h males
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
4.1
1.2
Not reported
Not reported
Not reported
Spleen - 2h females
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
4.3
1.0
Not reported
Not reported
Not reported
Stomach - 2h males
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
33
15
Not reported
Not reported
Not reported
Stomach - 2h females
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
72
10
Not reported
Not reported
Not reported
Thyroid - 2h males
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
55
31
Not reported
Not reported
Not reported
Thyroid - 2h females
Values in standardized uptake value (SUV) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Healthy Volunteers
50
11
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
0.39
value
0.8
title
Bone uptake - 2 h males
categories
measurements
group Id
OG000
spread
0.5
value
1.4
title
Bone uptake - 2 h females
categories
measurements
group Id
OG000
spread
0.14
value
0.39
title
Brain uptake - 2 h males
categories
measurements
group Id
OG000
spread
0.15
value
0.42
title
Brain uptake - 2 h females
categories
measurements
group Id
OG000
spread
0.4
value
2.8
title
Breast uptake - 2 h females
categories
measurements
group Id
OG000
spread
1.5
value
2.7
title
Gallbladder uptake - 2 h males
categories
measurements
group Id
OG000
spread
1.0
value
3.7
title
Gallbladder uptake - 2h females
categories
measurements
group Id
OG000
spread
1.0
value
2.9
title
Intestinal uptake - 2h males
categories
measurements
group Id
OG000
spread
2.7
value
5.0
title
Intestinal uptake - 2h females
categories
measurements
group Id
OG000
spread
2.5
value
7.0
title
Kidney uptake - 2h males
categories
measurements
group Id
OG000
spread
0.7
value
5.6
title
Kidney uptake - 2h females
categories
measurements
group Id
OG000
spread
1.0
value
2.3
title
Liver uptake - 2h males
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
0
group Id
OG002
value
0
units
Participants
description
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.
dispersion Type
Standard Deviation
groups
description
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
id
OG000
title
Healthy Volunteers
description
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
id
OG001
title
Myeloma Patients
description
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
id
OG002
title
Endometrial Cancer Patients
param Type
MEAN
population Description
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).
reporting Status
POSTED
time Frame
0-240 minutes
title
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
Triangle