- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04570033
The Utility of 18F-fluorocholine PET/CT in the Imaging of Parathyroid Adenomas
September 25, 2020 updated by: Andrzej Mazurek, Military Institute of Medicine, Poland
We assessed sensitivity of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism (PHPT).
Study Overview
Status
Completed
Conditions
Detailed Description
We prospectively enrolled 65 consecutive patients with PHPT who underwent neck ultrasound (US) and parathyroid scintigraphy (99mTc/99mTc-MIBI dual phase).
Twenty-two patients had unsuccessful parathyroid surgery prior to the study.
PET/CT scans were performed 65.0 ± 13.3 min after injection of 218.5 ± 31.9
MBq of 18F-fluorocholine (FCH).
Three experienced nuclear medicine physicians assessed the detection rate of hyperfunctioning parathyroid tissue.
Response to parathyroidectomy and clinical follow-up served as a reference test.
Per-patient sensitivity and positive predictive value (PPV) were calculated for patients who underwent surgery.
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- primary hyperparathyroidism and neck US and the dual-phase 99mTc/99mTc-MIBI SPECT/CT scintigraphy performed prior to the PET/CT scan
Exclusion Criteria:
- pregnancy
- patient's lack of consent to the examination
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: patients with hyperparathyroidism
We prospectively enrolled 65 consecutive patients with primary hyperparathyroidism (PHPT) who underwent neck ultrasound (US) and parathyroid scintigraphy (99mTc/99mTc-MIBI dual phase).
Twenty-two patients had unsuccessful parathyroid surgery prior to the study
|
We prospectively enrolled 65 consecutive patients with PHPT who underwent neck ultrasound (US) and parathyroid scintigraphy (99mTc/99mTc-MIBI dual phase).
Twenty-two patients had unsuccessful parathyroid surgery prior to the study.
PET/CT scans were performed 65.0 ± 13.3 min after injection of 218.5 ± 31.9
MBq of 18F-fluorocholine (FCH).
Three experienced nuclear medicine physicians assessed the detection rate of hyperfunctioning parathyroid tissue.
Response to parathyroidectomy and clinical follow-up served as a reference test.
Per-patient sensitivity and positive predictive value (PPV) were calculated for patients who underwent surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The utility of 18F-fluorocholine PET/CT in the imaging of parathyroid adenomas
Time Frame: 24 months
|
Sensitivity and positive predictive value of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Andrzej Mazurek, MD, PhD, Military Institute of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wilhelm SM, Wang TS, Ruan DT, Lee JA, Asa SL, Duh QY, Doherty GM, Herrera MF, Pasieka JL, Perrier ND, Silverberg SJ, Solorzano CC, Sturgeon C, Tublin ME, Udelsman R, Carty SE. The American Association of Endocrine Surgeons Guidelines for Definitive Management of Primary Hyperparathyroidism. JAMA Surg. 2016 Oct 1;151(10):959-968. doi: 10.1001/jamasurg.2016.2310.
- Cordellat IM. Hyperparathyroidism: primary or secondary disease? Reumatol Clin. 2012 Sep-Oct;8(5):287-91. doi: 10.1016/j.reuma.2011.06.001. Epub 2011 Oct 20.
- Lopez-Mora DA, Sizova M, Estorch M, Flotats A, Camacho V, Fernandez A, Abouzian S, Fuentes-Ocampo F, Garcia JIP, Ballesteros AIC, Duch J, Domenech A, Duarte AM, Carrio I. Superior performance of 18F-fluorocholine digital PET/CT in the detection of parathyroid adenomas. Eur J Nucl Med Mol Imaging. 2020 Mar;47(3):572-578. doi: 10.1007/s00259-020-04680-7. Epub 2020 Jan 9. Erratum In: Eur J Nucl Med Mol Imaging. 2020 Jun;47(6):1609.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
January 1, 2020
Study Completion (Actual)
January 1, 2020
Study Registration Dates
First Submitted
September 21, 2020
First Submitted That Met QC Criteria
September 25, 2020
First Posted (Actual)
September 30, 2020
Study Record Updates
Last Update Posted (Actual)
September 30, 2020
Last Update Submitted That Met QC Criteria
September 25, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Parathyroid Diseases
- Head and Neck Neoplasms
- Hyperparathyroidism
- Adenoma
- Parathyroid Neoplasms
- Physiological Effects of Drugs
- Calcium-Regulating Hormones and Agents
- Parathyroid Hormone
Other Study ID Numbers
- Military Institute of Medicine
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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