The Novel Approach of Minimally Invasive Parathyroid Surgery Requires Precise Identification and Localization of the Lesion Prior to Exploration

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ClinicalTrials.gov Identifier: NCT01226810

Recruitment Status : Unknown

Verified October 2010 by Rambam Health Care Campus.
Recruitment status was: Not yet recruiting

First Posted : October 22, 2010

Last Update Posted : October 22, 2010

Sponsor:

Information provided by:

Rambam Health Care Campus

Study Description

Brief Summary:

Purpose of this study is to compare the image quality and diagnostic accuracy obtained with ultrafast solid state short SPECT in comparison with the routine SPECT protocol.

Condition or disease
Hypercalcemia Hyperparathyroidism

Detailed Description:

Single-tracer, dual-phase Tc-MIBI parathyroid scintigraphy is based on the differential washout rate of the tracer (MIBI) from the thyroid and the parathyroid tissue. A distinct focus of increased MIBI uptake relative to the thyroid gland, either on the early or late image or on both, or a focal uptake in the mediastinum, is considered positive for abnormal parathyroid tissue. Tc99m-MIBI planar scintigraphy was found to play a major role in the preoperative localization of a parathyroid adenoma (PTA), with a sensitivity ranging from 85% to 95% and specificity of up to 99%. Subsequently, the use of MIBI- Single photon emission computed tomography (SPECT) significantly improved the sensitivity of the test and improved the accuracy of lesion localization.

A limitation of adding the SPECT component is related to its relatively long duration. The duration of a MIBI-SPECT acquisition of neck and the mediastinal area may take up to 15-20 minutes using a standard nuclear medicine camera. Long acquisition time may lead to patient discomfort and movement resulting in image degradation, artifacts and may lead to overall decreased diagnostic accuracy.

A reduced SPECT acquisition time without image quality degradation may decrease patient discomfort and increase clinical throughput. An ultrafast solid state CZT camera (GE Healthcare Discovery 570C) is currently used for routine cardiac SPECT imaging achieving high quality cardiac studies for a significantly shorter acquisition time. Present study evaluates the potential use of the ultrafast camera in patients with a clinically suspected PTA who perform Tc-MIBI imaging.

Study Design


Study Type :	Observational
Estimated Enrollment :	50 participants
Observational Model:	Case-Only
Time Perspective:	Cross-Sectional
Official Title:	A Novel Approach to Ultrafast Parathyroid SPECT Imaging Using a Solid State CZT SPECT Camera
Study Start Date :	January 2011

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients referred for the parathyroid scan.

Criteria

Inclusion Criteria:

1) The subject is 18 years old or older. (2) The subject is clinically suspected or known to have parathyroid adenoma and is scheduled to have a MIBI study as part of his/her standard clinical evaluation.

(3) The subject is able and willing to comply with the additional procedure (ultrafast MIBI SPECT) and a signed and dated informed consent is obtained before any procedure for study purposes is performed.

Exclusion Criteria:

Pregnancy.
Psychosis or any other condition, which, in the investigators opinion would prevent adherence to the study protocol.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226810

Contacts


Contact: Kinga Przewloka, MSc	+9728542816	k_przewloka@rambam.health.gov.il

Locations


Israel
Rambam Healthcare Campus	Not yet recruiting
Haifa, Israel, 36029
Contact: Kinga Przewloka, MSc 009728542816 k_przewloka@rambam.health.gov.il

Sponsors and Collaborators

Rambam Health Care Campus

Investigators


Principal Investigator:	Ora Israel, MD	Rambam Health Care Campus

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Safaeian M, Castellsagué X, Hildesheim A, Wacholder S, Schiffman MH, Bozonnat MC, Baril L, Rosillon D; Costa Rica HPV Vaccine Trial and the PATRICIA study groups . Risk of HPV-16/18 Infections and Associated Cervical Abnormalities in Women Seropositive for Naturally Acquired Antibodies: Pooled Analysis Based on Control Arms of Two Large Clinical Trials. J Infect Dis. 2018 Jun 5;218(1):84-94. doi: 10.1093/infdis/jiy112.


Responsible Party:	Prof. Ora Israel, RambamMC
ClinicalTrials.gov Identifier:	NCT01226810 History of Changes
Other Study ID Numbers:	024-10-RMB_parathyroid
First Posted:	October 22, 2010 Key Record Dates
Last Update Posted:	October 22, 2010
Last Verified:	October 2010

Additional relevant MeSH terms:


Hyperparathyroidism Hypercalcemia Parathyroid Diseases Endocrine System Diseases	Calcium Metabolism Disorders Metabolic Diseases Water-Electrolyte Imbalance

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