ClinicalTrials.gg
Status unknownNCT01226810Updated Oct 22, 2010

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

An observational study in Hypercalcemia and Hyperparathyroidism, sponsored by Rambam Health Care Campus. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-10-22.

Sponsored by Rambam Health Care Campus · Observational

The sponsor has not verified this record recently (last verified Oct 2010), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
50
Ages
18 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Hypercalcemia
  • Hyperparathyroidism
03

In context

Hypercalcemia

51 studies on the registry are indexed under Hypercalcemia; 9 are open to participants now.

This study's planned enrollment of 50 is below the median of 193 across 14 observational studies indexed under Hypercalcemia.

Browse Hypercalcemia studies →

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 466 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients referred for the parathyroid scan.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 is obtained before any procedure for study purposes is performed.

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy.
  2. Psychosis or any other condition, which, in the investigators opinion would prevent adherence to the study protocol.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
06

Study locations

1 site
07

References and documents

Publications

  • Chen J, Gopala K, Akarsh PK, Struyf F, Rosillon D. Prevalence and Incidence of Human Papillomavirus (HPV) Infection Before and After Pregnancy: Pooled Analysis of the Control Arms of Efficacy Trials of HPV-16/18 AS04-Adjuvanted Vaccine. Open Forum Infect Dis. 2019 Dec 4;6(12):ofz486. doi: 10.1093/ofid/ofz486. eCollection 2019 Dec. Erratum In: Open Forum Infect Dis. 2020 Feb 28;7(3):ofaa036. doi: 10.1093/ofid/ofaa036. PubMed 31824976 ↗
  • Safaeian M, Castellsague 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. PubMed 29718393 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01226810
First posted
Oct 22, 2010
Start date
Jan 2011
Last update
Oct 22, 2010

Study contacts

Kinga Przewloka, MSc
Contact
k_przewloka@rambam.health.gov.il
+9728542816
Ora Israel, MD
principal investigator · Rambam Health Care Campus

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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