NCT03764007

18F-Fluorocholine for the Detection of Parathyroid Adenomas

Completed Phase 2, PHASE3 Results posted Last updated 19 October 2021

What this trial tests

Phase 2, PHASE3 trial testing 18F-Fluorocholine in Hyperparathyroidism, Primary in 98 participants. Completed in 31 May 2021.

Timeline

21 September 2016

Primary endpoint
31 May 2021

31 May 2021

Quick facts

Lead sponsor	Thomas Hope
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	98
Start date	21 September 2016
Primary completion	31 May 2021
Estimated completion	31 May 2021
Sites	1 location across United States

Drugs / interventions tested

• 18F-Fluorocholine
• Positron Emission Tomography (PET) — full drug profile →

Conditions studied

• Hyperparathyroidism, Primary — all drugs for Hyperparathyroidism, Primary →

Sponsor

Thomas Hope — full company profile →

Who can join

13 and older, any sex, with Hyperparathyroidism, Primary. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma Primary · 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.

Group	Value	95% CI
18F-Fluorocholine PET	0.75	0.63 – 0.82

Proportion of True Positives for the Detection of the Abnormal Parathyroid Adenoma Using Sestamibi Imaging Primary · 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 co

Group	Value	95% CI
18F-Fluorocholine PET	0.70	0.59 – 0.79

Detection Rate in Patients Who Have Not Undergone Surgical Resection Secondary · 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.

Group	Value	95% CI
18F-Fluorocholine PET	0.90

Sponsor's own description

The investigators are studying the ability of F18 labeled fluorocholine PET to localize parathyroid adenomas in patients with hyperparathyroidism prior to surgery.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Accuracy of ¹⁸F-Fluorocholine PET for the Detection of Parathyroid Adenomas: Prospective Single-Center Study.
   Hope TA, Graves CE, Calais J, Ehman EC, et al · · 2021 · cited 16× · PMID 33674400 · DOI 10.2967/jnumed.120.256735