Trial Outcomes & Findings for Anti-3-[18F]FACBC Imaging of Parathyroid Adenomas (NCT NCT01574287)

Last Updated: 2019-07-02

Results Overview

Detection rate of parathyroid adenomas using anti-3-\[18F\]FACBC modality is assessed by comparing \[18F\]FACBC and surgical findings.

Recruitment status

COMPLETED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

At approximately 1 month post scan (time of surgery and pathologic analysis)

Results posted on

2019-07-02

Participant milestones
Measure	FACBC FACBC: Drug is give intravenously over 2 minutes at time of scan
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Anti-3-[18F]FACBC Imaging of Parathyroid Adenomas

Baseline characteristics by cohort
Measure	FACBC n=4 Participants FACBC: Drug is give intravenously over 2 minutes at time of scan
Age, Continuous	57 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

Timeframe: At approximately 1 month post scan (time of surgery and pathologic analysis)

Detection rate of parathyroid adenomas using anti-3-\[18F\]FACBC modality is assessed by comparing \[18F\]FACBC and surgical findings.

Outcome measures
Measure	FACBC n=4 Participants FACBC: Drug is give intravenously over 2 minutes at time of scan
Detection Rate of Parathyroid Adenomas of Anti-3-[18F]FACBC Modality	80 percentage of adenomas detected

Timeframe: 5-10 min after intravenous bolus injection of [18F]fluciclovine

To evaluate uptake mechanisms of anti-3-\[18F\]FACBC, target-to-background ratio (TBR) of anti-3-\[18F\]FACBC is assessed

Outcome measures
Measure	FACBC n=4 Participants FACBC: Drug is give intravenously over 2 minutes at time of scan
Target-to-background Ratio (TBR) of Anti-3-[18F]FACBC for Blood Pool	1.3 SUVmax Standard Deviation 0.6

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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