Back to results18F-Fluorocholine for the Detection of Parathyroid Adenomas
Primary Purpose
Hyperparathyroidism, Primary
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
18F-Fluorocholine
Positron Emission Tomography (PET)
Sponsored by
About this trial
This is an interventional diagnostic trial for Hyperparathyroidism, Primary focused on measuring Positron emission tomography
Eligibility Criteria
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.
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-Fluorocholine PET
Arm Description
Patients will undergo a single fluorocholine PET imaging study prior to surgery.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03764007
Brief Title
18F-Fluorocholine for the Detection of Parathyroid Adenomas
Official Title
18F-Fluorocholine for the Detection of Parathyroid Adenomas
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 21, 2016 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Hope
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators are studying the ability of F18 labeled fluorocholine PET to localize parathyroid adenomas in patients with hyperparathyroidism prior to surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism, Primary
Keywords
Positron emission tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
18F-Fluorocholine PET
Arm Type
Experimental
Arm Description
Patients will undergo a single fluorocholine PET imaging study prior to surgery.
Intervention Type
Drug
Intervention Name(s)
18F-Fluorocholine
Other Intervention Name(s)
Fluorocholine
Intervention Description
Given intravenously
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography (PET)
Other Intervention Name(s)
PET
Intervention Description
Imaging technique that uses radioactive agents known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities
Primary Outcome Measure Information:
Title
Proportion of True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma
Description
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.
Time Frame
Up to 1 year
Title
Proportion of True Positives for the Detection of the Abnormal Parathyroid Adenoma Using Sestamibi Imaging
Description
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.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Detection Rate in Patients Who Have Not Undergone Surgical Resection
Description
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.
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Hope, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://jnm.snmjournals.org/content/early/2021/03/12/jnumed.120.256735
Description
Journal of Nuclear Medicine, published on March 5, 2021 as doi:10.2967/jnumed.120.256735
Learn more about this trial
18F-Fluorocholine for the Detection of Parathyroid Adenomas
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