Parathyroid AdenomaNCT03516747
Preoperational Fine Needle Aspiration of Pathological Parathyroid Gland
A study testing pre operative parathyroid hormone level measurement, pre operative parathyroid cytology and parathyroid hormone level measurement in people with Parathyroid Adenoma and Hypercalcemia, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Identification and localization of pathological parathyroid gland before parathyroidectomy is traditionally done by a combination of two methods: ultrasound and sestamibi scan. The investigators would like to show that one exam that includes ultrasound and fine needle aspiration of the parathyroid gland for… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Parathyroid Adenoma, Hypercalcemia
- What is being tested?
- pre operative parathyroid hormone level measurement, pre operative parathyroid cytology and parathyroid hormone level measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Jun 2018to 9 Aug 2020
- Phase
- Interventional
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- above 18 years old
- participants that suffer from primary hyperparathyroidism with an indication for parathyroidectomy
Who cannot join
- Chronic renal failure
- kidney transplant participant
- MEN (multiple endocrine neoplasia) syndrome
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Fine Needle Aspiration of Parathyroid Gland as a Pre Operative Localization Tool to Identify Pathological Parathyroid
Identification and localization of pathological parathyroid gland before parathyroidectomy is traditionally done by a combination of two methods: ultrasound and sestamibi scan. The investigators would like to show that one exam that includes ultrasound and fine needle aspiration of the parathyroid gland for parathyroid hormone level is as accurate as the traditional method.
Read the detailed description
A prospective, open label, single arm trial that includes participants that suffer hypercalcemia due to primary hyperparathyroidism and are candidates for parathyroidectomy.
participants visit the investigator's head and neck clinic. the investigator confirms that the participant has an indication for parathyroidectomy according to the official criteria. Later on, the investigator looks at the localization tests that have already been done (neck ultrasound and MIBI [methoxyisobutyllisonitrile] scan) in order to plan the surgery. In case participant has not made those tests- the investigator fills a written request to do so. then, the investigator will perform a neck ultrasound and identifies the pathological parathyroid gland. The suspected pathological gland is aspirated using a 27 gauge needle attached to a 5 cc syringe fills with 1 cc saline (0.9% NaCL) under the guidance of the ultrasound. The aspirated material is sent for 2 examinations:
- parathyroid hormone level: the aspirated material is injected into a ethylenediaminetetraacetic acid (EDTA) vial and send to the hospital's endocrine laboratory. the parathyroid hormone level is processed using chemiluminescence method and represented in Pg/ml units.
- cytology examination. The aspirated material is spread on a glassed slide and prepared with a Giemsa stain for a cytologic examination. cytologic features such as cell type, cytoplasmic characteristics,cell block structure and chromatin appearance is addressed by the pathologist.
After completion of the ultrasound - guided needle aspiration the participant is given an exact date for the surgery.
The surgery is carried out routinely with the same surgical steps that the investigator is familiar with. At the end of surgery, after the pathological parathyroid gland was extracted from the neck, it is aspirated with a 27Gy needle attached to a 5 cc, syringe filled with a 1 cc saline (0.9% NaCL).
The aspirated material is sent to the same, above mentioned, examinations (parathyroid hormone level and cytology).
After the investigator receives the final pathological result of the suspected gland and confirm that the excised tissue was indeed a pathological parathyroid one, the investigators are able to answer 2 important questions:
- Is high level of parathyroid hormone which was aspirated from a suspected pathological parathyroid tissue is a good indicator that the tissue is indeed a pathological parathyroid.
- Is there a difference between parathyroid cytology of a tissue aspirated transcutaneously to a parathyroid cytology of material aspirated directly from the parathyroid gland.
- Conditions
- Parathyroid Adenoma, Hypercalcemia
- Being tested
- pre operative parathyroid hormone level measurement, pre operative parathyroid cytology, parathyroid hormone level measurement, parathyroid cytology
- Keywords
- cytology, parathyroidectomy, parathyroid hormone level
- Medical subject headings
- Parathyroid Neoplasms, Hypercalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre operative parathyroid hormone level measurementDiagnostic test
At the clinic, the participants will undergo ultrasound examination with fine needle aspiration. The aspirated material will be sent for parathyroid hormone level measurement.
pre operative parathyroid cytologyDiagnostic test
At the clinic, the participants will undergo neck ultrasound examination with fine needle aspiration. The aspirated material will be sent for cytology examination.
parathyroid hormone level measurementDiagnostic test
At surgery, after the pathologic gland is excised , the gland will be aspirated. The material will be sent for parathyroid hormone level measurement.
parathyroid cytologyDiagnostic test
At surgery, after the pathologic gland is excised , it will be aspirated again for cytologic examination.
| Study group | Role | What they receive |
|---|---|---|
| investigation group | Experimental | participants that suffer hypercalcemia due to primary hyperparathyroidism. include all participants in the trial Receives: Diagnostic Test: pre operative parathyroid hormone level measurement; Diagnostic Test: pre operative parathyroid cytology; Diagnostic Test: parathyroid hormone level measurement; Diagnostic Test: parathyroid cytology |
What is being measured
The primary outcome is the main question the study is designed to answer.
parathyroid hormone level from a pathological parathyroid gland
Under ultrasound guidance, the investigators will locate a neck leison which based on previous localization imaging modalities, is proven to be a pathological parathyroid gland.The investigators will aspirate material from this gland and send it for measurement of parathyroid hormone level. we will prove that a lesion that contains high levels of parathyroid hormone is indeed a parathyroid gland. thereby, this method may replace other localization methods
Measured: one month after the patient starts the study
parathyroid hormone level from a pathological parathyroid gland
At surgical final step, after the pathological parathyroid gland is ex vivo the investigator will aspirate material from it and send it for measurement of parathyroid hormone level. we will prove that a lesion that contains high levels of parathyroid hormone is indeed a parathyroid gland.
Measured: one month after the patient starts the study
Secondary outcomes (2)
parathyroid gland cytology from a pathological parathyroid gland.
Under ultrasound guidance, the investigators will locate a neck leison which based on previous localization imaging modalities, is proven to be a pathological parathyroid gland.The investigators will aspirate material from this gland and send it for cytology examination.By doing so we will investigate whether cytology that was aspirated from parathyroid gland trans cutaneously is different from a cytology of the gland aspirated directly (ex vivo-after it the gland excised from the body).
Measured: one month after the patient starts the study
parathyroid gland cytology
At surgical final step, after the pathological parathyroid gland is ex vivo the investigator will aspirate material from it and send it for cytology examination.By doing so the investigators will determine whether cytology that was aspirated from parathyroid gland trans cutaneously is different from a cytology of the gland aspirated directly (ex vivo- after it the gland excised from the body).
Measured: one month after the patient starts the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start9 Jun 2018
- Primary completion9 Apr 2020
- Study completion9 Aug 2020
Why it stopped: we gave up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parathyroid AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open label, non- randomised, prospective
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paker Miki, HaEmek Medical Center, Israel
- Investigators
- Dror Ashkenazi, M.D, Study director, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516747
- Sponsor's protocol ID
- 18-0005-EMC
- Status last verified
- Apr 2022
- First submitted
- 3 Apr 2018
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not make individual participant data available due to the desire to preserve the privacy of the participants in the study
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Fine Needle Aspiration of Parathyroid Gland as a Pre Operative Localization Tool to Identify Pathological Parathyroid
- ClinicalTrials.gov ID
- NCT03516747
- Acronym / sponsor ID
- 18-0005-EMC
- Conditions
- Parathyroid Adenoma, Hypercalcemia
- Keywords
- cytology, parathyroidectomy, parathyroid hormone level
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: we gave up
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 9 Jun 2018 (actual)
- Primary completion
- 9 Apr 2020 (actual)
- Study completion
- 9 Aug 2020 (actual)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Identification and localization of pathological parathyroid gland before parathyroidectomy is traditionally done by a combination of two methods: ultrasound and sestamibi scan. The investigators would like to show that one exam that includes ultrasound and fine needle aspiration of the parathyroid gland for parathyroid hormone level is as accurate as the traditional method.
Detailed description
A prospective, open label, single arm trial that includes participants that suffer hypercalcemia due to primary hyperparathyroidism and are candidates for parathyroidectomy.
participants visit the investigator's head and neck clinic. the investigator confirms that the participant has an indication for parathyroidectomy according to the official criteria. Later on, the investigator looks at the localization tests that have already been done (neck ultrasound and MIBI [methoxyisobutyllisonitrile] scan) in order to plan the surgery. In case participant has not made those tests- the investigator fills a written request to do so. then, the investigator will perform a neck ultrasound and identifies the pathological parathyroid gland. The suspected pathological gland is aspirated using a 27 gauge needle attached to a 5 cc syringe fills with 1 cc saline (0.9% NaCL) under the guidance of the ultrasound. The aspirated material is sent for 2 examinations:
- parathyroid hormone level: the aspirated material is injected into a ethylenediaminetetraacetic acid (EDTA) vial and send to the hospital's endocrine laboratory. the parathyroid hormone level is processed using chemiluminescence method and represented in Pg/ml units.
- cytology examination. The aspirated material is spread on a glassed slide and prepared with a Giemsa stain for a cytologic examination. cytologic features such as cell type, cytoplasmic characteristics,cell block structure and chromatin appearance is addressed by the pathologist.
After completion of the ultrasound - guided needle aspiration the participant is given an exact date for the surgery.
The surgery is carried out routinely with the same surgical steps that the investigator is familiar with. At the end of surgery, after the pathological parathyroid gland was extracted from the neck, it is aspirated with a 27Gy needle attached to a 5 cc, syringe filled with a 1 cc saline (0.9% NaCL).
The aspirated material is sent to the same, above mentioned, examinations (parathyroid hormone level and cytology).
After the investigator receives the final pathological result of the suspected gland and confirm that the excised tissue was indeed a pathological parathyroid one, the investigators are able to answer 2 important questions:
- Is high level of parathyroid hormone which was aspirated from a suspected pathological parathyroid tissue is a good indicator that the tissue is indeed a pathological parathyroid.
- Is there a difference between parathyroid cytology of a tissue aspirated transcutaneously to a parathyroid cytology of material aspirated directly from the parathyroid gland.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open label, non- randomised, prospective
| Arm | Type | Receives |
|---|---|---|
| investigation group | Experimental | Diagnostic Test: pre operative parathyroid hormone level measurement, Diagnostic Test: pre operative parathyroid cytology, Diagnostic Test: parathyroid hormone level measurement, Diagnostic Test: parathyroid cytologyparticipants that suffer hypercalcemia due to primary hyperparathyroidism. include all participants in the trial |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- above 18 years old
- participants that suffer from primary hyperparathyroidism with an indication for parathyroidectomy
Key exclusion criteria (4 listed)
- Chronic renal failure
- kidney transplant participant
- MEN (multiple endocrine neoplasia) syndrome
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre operative parathyroid hormone level measurementAt the clinic, the participants will undergo ultrasound examination with fine needle aspiration. The aspirated material will be sent for parathyroid hormone level measurement. | Diagnostic test | investigation group |
| pre operative parathyroid cytologyAt the clinic, the participants will undergo neck ultrasound examination with fine needle aspiration. The aspirated material will be sent for cytology examination. | Diagnostic test | investigation group |
| parathyroid hormone level measurementAt surgery, after the pathologic gland is excised , the gland will be aspirated. The material will be sent for parathyroid hormone level measurement. | Diagnostic test | investigation group |
| parathyroid cytologyAt surgery, after the pathologic gland is excised , it will be aspirated again for cytologic examination. | Diagnostic test | investigation group |
Primary outcome
parathyroid hormone level from a pathological parathyroid gland
Time frame: one month after the patient starts the study
Under ultrasound guidance, the investigators will locate a neck leison which based on previous localization imaging modalities, is proven to be a pathological parathyroid gland.The investigators will aspirate material from this gland and send it for measurement of parathyroid hormone level. we will prove that a lesion that contains high levels of parathyroid hormone is indeed a parathyroid gland. thereby, this method may replace other localization methods
parathyroid hormone level from a pathological parathyroid gland
Time frame: one month after the patient starts the study
At surgical final step, after the pathological parathyroid gland is ex vivo the investigator will aspirate material from it and send it for measurement of parathyroid hormone level. we will prove that a lesion that contains high levels of parathyroid hormone is indeed a parathyroid gland.
2 secondary outcomes
parathyroid gland cytology from a pathological parathyroid gland.
Time frame: one month after the patient starts the study
parathyroid gland cytology
Time frame: one month after the patient starts the study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: No. The investigators will not make individual participant data available due to the desire to preserve the privacy of the participants in the study
Related trials for Parathyroid Adenoma
RecruitingEarly Phase 1
Flurpiridaz F-18 PET/CT Imaging for Detecting Parathyroid Adenomas
Hyperparathyroidism
RecruitingPhase 2/3
Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
Primary Hyperparathyroidism, Parathyroid Cancer
Enrolling by invitationObservational study
Parathyroid Adenoma Detection With Rubidium-82 Imaging
Parathyroid Adenomas, Hyperparathyroidism, Primary
Active, not recruitingPhase 2
Agnostic Therapy in Rare Solid Tumors
Urachal Cancer, Parathyroid Carcinoma
RecruitingPhase 2/3
99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT
Parathyroid Adenoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dror Ashkenazi, M.D study director
haemek medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre operative parathyroid hormone level measurement, pre operative parathyroid cytology and parathyroid hormone level measurement in people with Parathyroid Adenoma and Hypercalcemia, run by HaEmek Medical Center, Israel 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 4 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: withdrawn, as of the sponsor's last update on 11 Apr 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parathyroid hormone level from a pathological parathyroid gland (time frame: one month after the patient starts the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2022.