The Utility of 18F-fluorocholine PET/CT in the Imaging of Parathyroid Adenomas
Primary Purpose
Hyperparathyroidism, Parathyroid Adenoma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
We assessed sensitivity of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism
Sponsored by
About this trial
This is an interventional diagnostic trial for Hyperparathyroidism focused on measuring PET/CT, fluorocholine
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients with hyperparathyroidism
Arm Description
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
Outcomes
Primary Outcome Measures
The utility of 18F-fluorocholine PET/CT in the imaging of parathyroid adenomas
Sensitivity and positive predictive value of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism
Secondary Outcome Measures
Full Information
NCT ID
NCT04570033
First Posted
September 21, 2020
Last Updated
September 25, 2020
Sponsor
Military Institute od Medicine National Research Institute
Collaborators
Medical University of Warsaw
1. Study Identification
Unique Protocol Identification Number
NCT04570033
Brief Title
The Utility of 18F-fluorocholine PET/CT in the Imaging of Parathyroid Adenomas
Official Title
The Utility of 18F-fluorocholine PET/CT in the Imaging of Parathyroid Adenomas
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Military Institute od Medicine National Research Institute
Collaborators
Medical University of Warsaw
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We assessed sensitivity of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism (PHPT).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism, Parathyroid Adenoma
Keywords
PET/CT, fluorocholine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients with hyperparathyroidism
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
We assessed sensitivity of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism
Intervention 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.
Primary Outcome Measure Information:
Title
The utility of 18F-fluorocholine PET/CT in the imaging of parathyroid adenomas
Description
Sensitivity and positive predictive value of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism
Time Frame
24 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrzej Mazurek, MD, PhD
Organizational Affiliation
Military Institute of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22089066
Citation
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.
Results Reference
result
PubMed Identifier
27532368
Citation
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.
Results Reference
result
PubMed Identifier
31919634
Citation
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.
Results Reference
result
Learn more about this trial
The Utility of 18F-fluorocholine PET/CT in the Imaging of Parathyroid Adenomas
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