Trial Outcomes & Findings for 18F-Fluorocholine for the Detection of Parathyroid Adenomas (NCT NCT03764007)

NCT ID: NCT03764007

Last Updated: 2021-10-19

Results Overview

The true positive (sensitivity) rate is defined as the proportion of participants with location of the suspected adenoma on 18F-Fluorocholine PET correlating with location of an abnormal parathyroid at time of participant surgery. For a patient with multiple hyperplastic glands, only one gland needs to correlate for the patient to count as a true positive. For analysis, adenomas described as arising in the mid thyroid bed will considered correct if located in either the inferior or superior bed. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 98 participants
• Primary outcome timeframe: Up to 1 year
• Results posted on: 2021-10-19

Participant Flow

Participant milestones

Measure	18F-Fluorocholine PET Patients will undergo a single fluorocholine PET imaging study prior to surgery. 18F-Fluorocholine: Given intravenously Positron Emission Tomography (PET): Imaging technique that uses radioactive agents known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities
Overall Study STARTED	98
Overall Study Imaging Completed	98
Overall Study Underwent Parathyroidectomy Surgery	77
Overall Study COMPLETED	77
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

18F-Fluorocholine for the Detection of Parathyroid Adenomas

Baseline characteristics by cohort

Measure	18F-Fluorocholine PET n=98 Participants Patients will undergo a single fluorocholine PET imaging study prior to surgery. 18F-Fluorocholine: Given intravenously Positron Emission Tomography (PET): Imaging technique that uses radioactive agents known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	83 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	9 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	5 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants
Region of Enrollment United States	98 Participants n=5 Participants
Prior History of Parathyroidectomy at Baseline	41 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year

The true positive (sensitivity) rate is defined as the proportion of participants with location of the suspected adenoma on 18F-Fluorocholine PET correlating with location of an abnormal parathyroid at time of participant surgery. For a patient with multiple hyperplastic glands, only one gland needs to correlate for the patient to count as a true positive. For analysis, adenomas described as arising in the mid thyroid bed will considered correct if located in either the inferior or superior bed. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year.

Outcome measures

Measure	18F-Fluorocholine PET n=77 Participants Patients will undergo a single fluorocholine PET imaging study prior to surgery. 18F-Fluorocholine: Given intravenously Positron Emission Tomography (PET): Imaging technique that uses radioactive agents known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities
Proportion of True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma	0.75 proportion of participants Interval 0.63 to 0.82

PRIMARY outcome

Timeframe: Up to 1 year

Population: Only 66 of the 77 participants who underwent surgery had an available sestamibi study

The true positive (sensitivity) rate is defined as the proportion of participants with location of the suspected adenoma on 18F-Fluorocholine PET correlating with location of an abnormal parathyroid at time of participant surgery. For a patient with multiple hyperplastic glands, only one gland needs to correlate for the patient to count as a true positive. In patients who had a sestamibi study performed prior to the fluorocholine imaging study, the original dictated report from the sestamibi will be used for comparison. For analysis, adenomas described as arising in the mid thyroid bed will considered correct if located in either the inferior or superior bed. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year.

Outcome measures

Measure	18F-Fluorocholine PET n=66 Participants Patients will undergo a single fluorocholine PET imaging study prior to surgery. 18F-Fluorocholine: Given intravenously Positron Emission Tomography (PET): Imaging technique that uses radioactive agents known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities
Proportion of True Positives for the Detection of the Abnormal Parathyroid Adenoma Using Sestamibi Imaging	0.70 proportion of participants Interval 0.59 to 0.79

SECONDARY outcome

Timeframe: Up to 1 year

The detection rate is defined as the proportion of participants with a 18F-fluorocholine PET positive read who do not subsequently undergo parathyroidectomy, using the dictated reports to determine the detection sensitivity for parathyroid adenomas. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year.

Outcome measures

Measure	18F-Fluorocholine PET n=21 Participants Patients will undergo a single fluorocholine PET imaging study prior to surgery. 18F-Fluorocholine: Given intravenously Positron Emission Tomography (PET): Imaging technique that uses radioactive agents known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities
Detection Rate in Patients Who Have Not Undergone Surgical Resection	0.90 proportion of participants

Adverse Events

18F-Fluorocholine PET

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

Dr. Thomas A. Hope, MD

University of California, San Francisco

Phone: (415) 221-4810

Email: Thomas.Hope@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place