18F-Fluorocholine for the Detection of Parathyroid Adenomas

Thomas Hope

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hyperparathyroidism, Primary

Treatments: Drug: 18F-Fluorocholine; Procedure: Positron Emission Tomography (PET)

Study type: Interventional

Funder types: Other

Identifiers

NCT03764007

16-19297

Details and patient eligibility

About

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

Enrollment: 98 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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98 participants in 1 patient group

18F-Fluorocholine PET

Experimental group

Description:

Patients will undergo a single fluorocholine PET imaging study prior to surgery.

Treatment:

Procedure: Positron Emission Tomography (PET)

Drug: 18F-Fluorocholine