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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03764007
Other study ID # 16-19297
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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