NCT02907073 · STUDY IN CONTEXT

Positron Emission Tomography (PET) Imaging Studies With NIS Reporter

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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 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).

→

secondary · POSTED

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.

Healthy volunteers do not have tumors. The study in myeloma and endometrial cancer was terminated due to pursuing IND.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-endometrial-cancer
nct id: NCT02907073
trial label: Positron Emission Tomography (PET) Imaging Studies With NIS Reporter
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 2
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer
nct id
NCT02907073
outcome key
om-0000
source section id
NCT02907073-om-0000
source outcome index
0
endpoint
Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers
endpoint definition
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.
time origin
0-240 minutes
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer
nct id
NCT02907073
outcome key
om-0001
source section id
NCT02907073-om-0001
source outcome index
1
endpoint
Amount of Imaging Agent in Tumor (Uptake) in Myeloma and Endometrial Cancer Patients
endpoint definition
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.
time origin
Baseline, Day 9
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Healthy volunteers do not have tumors. The study in myeloma and endometrial cancer was terminated due to pursuing IND.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer
nct id
NCT02907073
outcome key
om-0000
arm key
OG000
arm label
Healthy Volunteers
regimen
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
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02907073-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer
nct id
NCT02907073
outcome key
om-0000
arm key
OG001
arm label
Myeloma Patients
regimen
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
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02907073-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer
nct id
NCT02907073
outcome key
om-0000
arm key
OG002
arm label
Endometrial Cancer Patients
regimen
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
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02907073-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer
nct id
NCT02907073
outcome key
om-0001
arm key
OG000
arm label
Healthy Volunteers
regimen
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
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02907073-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer
nct id
NCT02907073
outcome key
om-0001
arm key
OG001
arm label
Myeloma Patients
regimen
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
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02907073-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer
nct id
NCT02907073
outcome key
om-0001
arm key
OG002
arm label
Endometrial Cancer Patients
regimen
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
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02907073-om-0001#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer
nct id
NCT02907073
harm key
EG000
source section id
NCT02907073-ae
event group key
EG000
event group label
Healthy Volunteers
serious affected
0
serious at risk
8
other affected
0
other at risk
8
frequency threshold
0
collection period
Adverse event data collection was defined as 24 hours following last administration of study treatment.
event definition
The study in eight healthy volunteers was completed. The study arms in myeloma and endometrial cancer were terminated due to pursuing IND.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer
nct id
NCT02907073
harm key
EG001
source section id
NCT02907073-ae
event group key
EG001
event group label
Myeloma Patients
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
0
collection period
Adverse event data collection was defined as 24 hours following last administration of study treatment.
event definition
The study in eight healthy volunteers was completed. The study arms in myeloma and endometrial cancer were terminated due to pursuing IND.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer
nct id
NCT02907073
harm key
EG002
source section id
NCT02907073-ae
event group key
EG002
event group label
Endometrial Cancer Patients
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
0
collection period
Adverse event data collection was defined as 24 hours following last administration of study treatment.
event definition
The study in eight healthy volunteers was completed. The study arms in myeloma and endometrial cancer were terminated due to pursuing IND.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice