A Phase 2/3 interventional study of 18F-Fluorocholine and Positron Emission Tomography (PET) in Hyperparathyroidism, Primary, sponsored by Thomas Hope. Completed at 1 site in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2021-10-19.
Sponsored by Thomas Hope · Phase 2/3, Interventional, and Diagnostic
The investigators are studying the ability of F18 labeled fluorocholine PET to localize parathyroid adenomas in patients with hyperparathyroidism prior to surgery.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's enrollment of 98 is below the median of 250 across 412 interventional studies indexed under Adenoma.
Browse Adenoma studies →Thomas Hope is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will undergo a single fluorocholine PET imaging study prior to surgery.
Drug: 18F-Fluorocholine · Procedure: Positron Emission Tomography (PET)
Given intravenously
Also known as: Fluorocholine
Imaging technique that uses radioactive agents known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities
Also known as: PET
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
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
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
| Milestone | 18F-Fluorocholine PET |
|---|---|
| Started | 98 |
| Imaging completed | 98 |
| Underwent parathyroidectomy surgery | 77 |
| Completed | 77 |
| Not completed | 21 |
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 participants | 18F-Fluorocholine PET |
|---|---|
| Proportion of True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma | 0.75 (0.63 to 0.82) |
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.
| proportion of participants | 18F-Fluorocholine PET |
|---|---|
| Proportion of True Positives for the Detection of the Abnormal Parathyroid Adenoma Using Sestamibi Imaging | 0.70 (0.59 to 0.79) |
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.
| proportion of participants | 18F-Fluorocholine PET |
|---|---|
| Detection Rate in Patients Who Have Not Undergone Surgical Resection | 0.90 |
Collected over 1 day. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 18F-Fluorocholine PET | 0/98 (0%) | 0/98 (0%) | 0/98 (0%) |
| Age, Continuous(years) | 18F-Fluorocholine PET |
|---|---|
| Median | 64 (17 to 90) |
| Sex: Female, Male(Participants) | 18F-Fluorocholine PET |
|---|---|
| Female | 72 |
| Male | 26 |
| Ethnicity (NIH/OMB)(Participants) | 18F-Fluorocholine PET |
|---|---|
| Hispanic or Latino | 10 |
| Not Hispanic or Latino | 83 |
| Unknown or Not Reported | 5 |
| Race (NIH/OMB)(Participants) | 18F-Fluorocholine PET |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 9 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 64 |
| More than one race | 5 |
| Unknown or Not Reported | 13 |
| Region of Enrollment(Participants) | 18F-Fluorocholine PET |
|---|---|
| United States | 98 |
| Prior History of Parathyroidectomy at Baseline(Participants) | 18F-Fluorocholine PET |
|---|---|
| Count of participants | 41 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Thomas Hope