18F-Fluorocholine for the Detection of Parathyroid Adenomas

Hyperparathyroidism, Primary Clinical Trial

Official title:

18F-Fluorocholine for the Detection of Parathyroid Adenomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764007
• Other study ID #: 16-19297
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 21, 2016
• Est. completion date: May 31, 2021

Study information

• Verified date: August 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators are studying the ability of F18 labeled fluorocholine PET to localize parathyroid adenomas in patients with hyperparathyroidism prior to surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

• Biochemically proven hyperparathyroidism and an indication for surgery
• Age >= 13 years old
• Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
• Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

• Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
• Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
• Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).
• Pregnancy.

Related Conditions & MeSH terms

• Adenoma
• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Parathyroid Neoplasms

Intervention

Drug:
• 18F-Fluorocholine
Given intravenously

Procedure:
• 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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Hope

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma	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.	Up to 1 year
Primary	Proportion of True Positives for the Detection of the Abnormal Parathyroid Adenoma Using Sestamibi Imaging	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.	Up to 1 year
Secondary	Detection Rate in Patients Who Have Not Undergone Surgical Resection	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.	Up to 1 year

External Links

•   Journal of Nuclear Medicine, published on March 5, 2021 as doi:10.2967/jnumed.120.256735