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HypercalcemiaNCT01226810

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

An observational study of Hypercalcemia and Hyperparathyroidism, run by Rambam Health Care Campus at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hypercalcemia, Hyperparathyroidism
How many people
50 participants
Where
1 siteIsrael
Study dates
Jan 2011to not given
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients referred for the parathyroid scan.

Who may be able to join

  • 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.
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Kinga Przewloka, MSc contact

+9728542816

k_przewloka@rambam.health.gov.il

Israel1 site

  • Rambam Healthcare Campus

    Haifa, 36029

    Kinga Przewloka, MSc, 009728542816, k_przewloka@rambam.health.gov.il

Other trials in Israel

About this study

Official title: A Novel Approach to Ultrafast Parathyroid SPECT Imaging Using a Solid State CZT SPECT Camera

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.

Medical subject headings
Hypercalcemia, Hyperparathyroidism

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2010 (estimated)
  2. Study startJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01226810
Sponsor's protocol ID
024-10-RMB_parathyroid
Status last verified
Oct 2010
First submitted
21 Oct 2010
Last updated
22 Oct 2010
Results posted
No
Data monitoring committee
No

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.

    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

Questions about this trial

What is this clinical trial studying?

An observational study of Hypercalcemia and Hyperparathyroidism, run by Rambam Health Care Campus at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kinga Przewloka, MSc (+9728542816, k_przewloka@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01226810, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2010.

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