Additional imaging techniques for localizing parathyroid adenomas in patients with primary hyperparathyroidism

Prospective, primarily direct comparison of 11C-methionine PET versus 11C-choline PET, and secondary 4D-CT, to explore what PET tracer to use and in which order to use the functional versus the anatomical imaging technique in the setting of primary hyperparathyroidism

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24844

Enrollment

Registered

2018-07-16

Start date

2018-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary hyperparathyroidism Keywords: pHPT Imaging 11C-methionine PET/CT 11C-choline PET/CT 4D-CT

Interventions

Patients participating in this study, after having given informed consent, will undergo additional imaging to the standard clinical care

namely 11C-choline PET/CT and if not already performed 4D-CT. Patients will undergo 11C-methionine PET/CT, as is standard clinical care. The outcome of these imaging techniques will be compared with

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Patients ¡Ý 18 years 2. Patients have biochemically confirmed primary hyperparathyroidism (pHPT) a. Patients with recurrent pHPT (calcium levels prior normalized for at least one year) will be eligible for inclusion 3. Patients with prior negative, inconclusive or discordant localizing imaging on MIBI(-SPECT/(CT)) and/or cUS as concluded at the MDO. 4. Patients have an indication for parathyroidectomy 5. Patients are eligible for surgery 6. Patients are able to give informed consent

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Patients with a germline mutation predisposing for multiple gland disease 2. Patients with an alternative diagnosis (e.g. parathyroid carcinoma) known before surgery 3. Patients with a previous negative neck exploration for pHPT 4. Patients with persistent primary hyperparathyroidism (pHPT) 5. Patients with renal dysfunction, eGFR < 30 ml/min*1.73 m2 6. Patients with known allergy for iodinated contrast 7. Pregnant patients

Design outcomes

Primary

Measure	Time frame
Primary outcome is the performance (sensitivity), of 11C-MET PET/CT and 11C-choline PET/CT to detect parathyroid adenoma(s) (PTA) in patients with primary hyperparathyroidism.	—

Secondary

Measure	Time frame
Secondary outcome is the positive predictive value (PPV) of 11C-MET PET/CT and 11C-choline PET/CT and the performance of 4D-CT (sensitivity and PPV) to detect parathyroid adenomas in patients with primary hyperparathyroidism.	—

Contacts

Public ContactMilou E Noltes

Nucleaire Geneeskunde, HPC EB50

m.e.noltes@umcg.nl0610755161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)