Parathyroid Disease
Conditions
Brief summary
Hyperparathyroidism (excessive production of parathyroid hormone (PTH) usually caused by a small growth called an adenoma in the parathyroid glands) is an increasingly significant medical and public health condition. Surgery is the only effective management for primary hyperparathyroidism. However; it is sometimes difficult to pinpoint the adenoma, in part because current methods of imaging often fail to identify the parathyroid adenoma in as many as 30% of patients. In reoperative parathyroidectomy for persistent or recurrent hyperparathyroidism, localization plays an even greater role. Unfortunately current multiple imaging methods fail to localize 10-15% these of tumors. SPECT/CT with the radiotracer 99mTc sestamibi has become the standard method for pinpointing the tumor. This, however, is a challenge because the parathyroid glands usually are located close to the thyroid and the radiotracer 99mTc sestamibi concentrates both in thyroid and parathyroid tissue. Hence there is a need for a tracer/imaging tool that concentrates in the parathyroid but not in the thyroid. A more sensitive and specific radiotracer/tracking agent would markedly improve the investigators ability to identify parathyroid tumors preoperatively, and thus offer more patients a minimally invasive parathyroidectomy. anti-3-\[18F\]FACBC is an amino acid based PET radiotracer which has shown utility in detecting a variety of tumors. In cell culture experiments, anti-3-\[18F\]FACBC has shown uptake in parathyroid cells greater than thyroid cells. Therefore, the investigators think that this radiotracer may be able to help us identify parathyroid adenomas better than 99mTc sestamibi. The primary aim of this study is to determine if anti-3-\[18F\]FACBC PET-CT demonstrates uptake within parathyroid adenomas. 12 patients with a diagnosis of primary hyperparathyroidism will undergo PET-CT using anti-3-\[18F\]FACBC in addition to the standard 99mTc sestamibi scanning and other imaging as clinically appropriate such as ultrasound, MRI, and/or contrast enhanced CT scanning. Since all these patients undergo surgery routinely, the investigators will then compare findings at surgery to those of the anti-3-\[18F\]FACBC PET-CT to determine if this radiotracer is worthy of further study in a more comprehensive experiment.
Interventions
DRUGFACBC
Drug is give intravenously over 2 minutes at time of scan
Sponsors
David M. Schuster, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Patients must be 18 years of age or older. 2. Patients will have biochemical and/or clinical evidence of primary hyperparathyroidism and be a surgical candidate for definitive parathyroid surgery . 3. Ability to lie still for PET scanning 4. Patients must be able to provide written informed consent
Exclusion criteria
1. Age less than 18. 2. Inability to lie still for PET scanning. 3. Cannot provide written informed consent. 4. History of secondary hyperparathyroidism. 5. Positive serum or urine pregnancy test within 24 hours of imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection Rate of Parathyroid Adenomas of Anti-3-[18F]FACBC Modality | At approximately 1 month post scan (time of surgery and pathologic analysis) | Detection rate of parathyroid adenomas using anti-3-\[18F\]FACBC modality is assessed by comparing \[18F\]FACBC and surgical findings. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target-to-background Ratio (TBR) of Anti-3-[18F]FACBC for Blood Pool | 5-10 min after intravenous bolus injection of [18F]fluciclovine | To evaluate uptake mechanisms of anti-3-\[18F\]FACBC, target-to-background ratio (TBR) of anti-3-\[18F\]FACBC is assessed |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FACBC FACBC: Drug is give intravenously over 2 minutes at time of scan | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | FACBC |
|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Detection Rate of Parathyroid Adenomas of Anti-3-[18F]FACBC Modality
Detection rate of parathyroid adenomas using anti-3-\[18F\]FACBC modality is assessed by comparing \[18F\]FACBC and surgical findings.
Time frame: At approximately 1 month post scan (time of surgery and pathologic analysis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FACBC | Detection Rate of Parathyroid Adenomas of Anti-3-[18F]FACBC Modality | 80 percentage of adenomas detected |
Secondary
Target-to-background Ratio (TBR) of Anti-3-[18F]FACBC for Blood Pool
To evaluate uptake mechanisms of anti-3-\[18F\]FACBC, target-to-background ratio (TBR) of anti-3-\[18F\]FACBC is assessed
Time frame: 5-10 min after intravenous bolus injection of [18F]fluciclovine
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FACBC | Target-to-background Ratio (TBR) of Anti-3-[18F]FACBC for Blood Pool | 1.3 SUVmax | Standard Deviation 0.6 |