18F-fluorocholine PET/CT for Hyperparathyroidism

NCT04316845 | Completed DMC

• 1 other identifier: IRB106-74-A
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Hyperparathyroidism is a common endocrine disorder which can result in many severe complications. For patients with hyperparathyroidism, Tc-99m sestamibi imaging is the major imaging tool for pre-operative localization of the hyperfunctioning gland. However, sestamibi scan have only limited sensitivity in detecting multigland disease and hyperplastic foci. New imaging tracer with 18F-fluorocholine (18F-FCH) has showed avidity in parathyroid tissues. Nevertheless, the research data of 18F-FCH PET/CT are only preliminary. The goal of our study is to compare the diagnostic performance of 18F-FCH PET/CT and single isotope dual phase sestamibi scintigraphy for patients with hyperparathyroidism. From Jan. 1st, 2018 till Dec. 31st, 2019, the investigators will prospectively enroll patients with biochemical evidence of hyperparathyroidism and intended to receive pre-operative image study. The patients will receive single isotope dual phase sestamibi scintigraphy and 18F-FCH PET/CT. Each image will be evaluated by experienced interpreter for abnormal uptake suspicious for hyperfunctioning parathyroid gland. The reference standard will be the final surgical results. Diagnostic performance of both sestamibi scan and PET/CT scan will be measured and calculated.

Conditions

Hyperparathyroidism

Keywords

Hyperparathyroidism; sestamibi; scintigraphy; 18F-Fluorocholine, PET

Outcome Measures

Primary Outcomes (3)

• The sensitivities of 18F-fluorocholine PET/CT and 99mTc sestamibi scan

  The lesion-based sensitivities of these two image modalities using surgical pathology of the parathyroid gland as reference standard (The number of true positive image findings/The number of pathologically confirmed parathyroid adenoma or hyperplasia)

  6 weeks

• The specificities of 18F-fluorocholine PET/CT and 99mTc sestamibi scan

  The lesion-based specificities of these two image modalities using surgical pathology of the parathyroid gland as reference standard (The number of true negative image findings/The number of negative finding on surgical pathology)

  6 weeks

• The accuracies of 18F-fluorocholine PET/CT and 99mTc sestamibi scan

  The lesion-based accuracies of these two image modalities using surgical pathology of the parathyroid gland as reference standard (True positive and true negative image findings/The number of all surgical specimens)

  6 weeks

Study Arms (1)

18F-fluorocholine PET/CT

EXPERIMENTAL

18F-fluorocholine PET/CT

Diagnostic Test: 18F-fluorocholine PET/CT

Interventions

18F-fluorocholine PET/CT DIAGNOSTIC_TEST

Patients undergo both 18F-fluorocholine PET/CT and Single isotope dual phase Tc-99m sestamibi scan (both planar scan and SPECT/CT)

Also known as: Tc-99m sestamibi scintigraphy

18F-fluorocholine PET/CT

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are diagnosed to have hyperparathyroidism based on serum iPTH data (\> 72 pg/mL).
• Planned to undergo surgical resection of the hyperfunctioning parathyroid gland.
• Referred for single isotope dual phase Tc-99m sestamibi scintigraphy.
• The 18F-FCH PET is performed within 6 weeks of the single isotope dual phase Tc-99m sestamibi scintigraphy.
• If premenopausal and sexually active woman, need contraception (tubal ligation, intrauterine devices, or oral contracepts/condom after the last menstrual period till the image exams)

You may not qualify if:

• Surgical management is not considered.
• Younger than 20-year-old.
• Factors that hampers the patient to receive positron emission tomography, e.g., unstable vital signs (shock), conscious disturbance, claustrophobia, etc...
• Allergic to investigaional drug.
• Pregnant or lactating woman.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Hualien Tzu Chi Hospital

Hualien City, 970, Taiwan

Location

Related Publications (1)

• Chen YH, Chen HT, Lee MC, Liu SH, Wang LY, Lue KH, Chan SC. Preoperative F-18 fluorocholine PET/CT for the detection of hyperfunctioning parathyroid glands in patients with secondary or tertiary hyperparathyroidism: comparison with Tc-99m sestamibi scan and neck ultrasound. Ann Nucl Med. 2020 Aug;34(8):527-537. doi: 10.1007/s12149-020-01479-2. Epub 2020 May 20.

  PMID: 32436180 DERIVED

MeSH Terms

Conditions

Hyperparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Shu-Hsin Liu, M.D.

  Hualien Tzu Chi Hospital, Buddhist Tzu ChiMedical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient undergoes both 18F-fluorocholine PET/CT and sestamibi scan

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 20, 2020
• Study Start: January 16, 2018
• Primary Completion: November 6, 2019
• Study Completion: December 31, 2019
• Last Updated: August 7, 2024

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)