Hyperparathyroidism, Primary
Conditions
Keywords
Positron emission tomography
Brief summary
The investigators are studying the ability of F18 labeled fluorocholine PET to localize parathyroid adenomas in patients with hyperparathyroidism prior to surgery.
Interventions
Given intravenously
PROCEDUREPositron 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
Sponsors
Thomas Hope
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma | 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. |
| Proportion of True Positives for the Detection of the Abnormal Parathyroid Adenoma Using Sestamibi Imaging | 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. 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
| Measure | Time frame | Description |
|---|---|---|
| Detection Rate in Patients Who Have Not Undergone Surgical Resection | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 98 |
| Total | 98 |
Baseline characteristics
| Characteristic | 18F-Fluorocholine PET |
|---|---|
| Age, Continuous | 64 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 83 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Prior History of Parathyroidectomy at Baseline | 41 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) White | 64 Participants |
| Region of Enrollment United States | 98 Participants |
| Sex: Female, Male Female | 72 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 98 |
| other Total, other adverse events | 0 / 98 |
| serious Total, serious adverse events | 0 / 98 |
Outcome results
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.
Time frame: Up to 1 year
Population: Only 66 of the 77 participants who underwent surgery had an available sestamibi study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 18F-Fluorocholine PET | Proportion of True Positives for the Detection of the Abnormal Parathyroid Adenoma Using Sestamibi Imaging | 0.70 proportion of participants |
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.
Time frame: Up to 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 18F-Fluorocholine PET | Proportion of True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma | 0.75 proportion of participants |
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.
Time frame: Up to 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 18F-Fluorocholine PET | Detection Rate in Patients Who Have Not Undergone Surgical Resection | 0.90 proportion of participants |