HyperparathyroidismNCT01221896
Input of C11-Choline PET/CT in Localization of Parathyroid Adenoma
An observational study of Hyperparathyroidism, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The purpose of the study is to determine a possible input of C11-Choline PET/CT in identification and localization of a parathyroid adenoma (PTA). Preoperative localization of a PTA has been previously documented in multiple series, and is usually based on scintigraphy and on US. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperparathyroidism
- What is being tested?
- C11-Choline PET/CT
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Jan 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with elevated PTH in search of a PTA
Who may be able to join
- Elevation of a calcium and parathyroid hormone in the serum
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Hebrew University Medical Center
Jerusalem, 91120
Marina Orevi, MD, 0508946211, marinaor@hadassah.org.il
About this study
The purpose of the study is to determine a possible input of C11-Choline PET/CT in identification and localization of a parathyroid adenoma (PTA).
Preoperative localization of a PTA has been previously documented in multiple series, and is usually based on scintigraphy and on US.
Read more
Currently, the conventional technique for localization of a PTA is a dual-isotope scan with Tc99m-MIBI and Tc99m pertechnetate. This study is acquired over at least 3 hours, includes two i.v. injections and the patient has to stay 15-30 min per acquisition under the camera.
In addition, there is no anatomical imaging and further correlation with US is usually recommended.
In contrast, PET/CT study with C11-Choline takes as long as 10 min., includes one injection, and provides data of higher resolution of functional (PET) and anatomical imaging (CT).
Furthermore, dosimetric data shows that the total effective dose from Tc99mMIBI and Tc99m pertechnetate injection is (without CT): 0.5957 rem; and from C11-Choline injection and CT of a chest is: 0.3128 - 0.8628rem.
- Conditions
- Hyperparathyroidism
- Being tested
- C11-Choline PET/CT
- Keywords
- Localization of a parathyroid adenoma in patients with primary hyperparathyroidism.
- Medical subject headings
- Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C11-Choline PET/CTProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Hyperparathyroidism | Patients with hyperparathyroidism, prior to surgery. Receives: Procedure: C11-Choline PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved localization of a parathyroid adenoma
Secondary outcomes (1)
Facilitation of detection of the parathyroid adenoma at surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221896
- Sponsor's protocol ID
- choline2010-HMO-CTIL
- Status last verified
- Oct 2010
- First submitted
- 14 Oct 2010
- Last updated
- 15 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Input of C11-Choline PET/CT in Localization of Parathyroid Adenoma
- ClinicalTrials.gov ID
- NCT01221896
- Acronym / sponsor ID
- choline2010-HMO-CTIL
- Conditions
- Hyperparathyroidism
- Keywords
- Localization of a parathyroid adenoma in patients with primary hyperparathyroidism.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2014 (estimated)
- First posted
- 15 Oct 2010 (estimated)
- 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.
The purpose of the study is to determine a possible input of C11-Choline PET/CT in identification and localization of a parathyroid adenoma (PTA).
Preoperative localization of a PTA has been previously documented in multiple series, and is usually based on scintigraphy and on US.
Currently, the conventional technique for localization of a PTA is a dual-isotope scan with Tc99m-MIBI and Tc99m pertechnetate. This study is acquired over at least 3 hours, includes two i.v. injections and the patient has to stay 15-30 min per acquisition under the camera.
In addition, there is no anatomical imaging and further correlation with US is usually recommended.
In contrast, PET/CT study with C11-Choline takes as long as 10 min., includes one injection, and provides data of higher resolution of functional (PET) and anatomical imaging (CT).
Furthermore, dosimetric data shows that the total effective dose from Tc99mMIBI and Tc99m pertechnetate injection is (without CT): 0.5957 rem; and from C11-Choline injection and CT of a chest is: 0.3128 - 0.8628rem.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperparathyroidism | – | Procedure: C11-Choline PET/CTPatients with hyperparathyroidism, prior to surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with elevated PTH in search of a PTA
Key inclusion criteria (1 listed)
- Elevation of a calcium and parathyroid hormone in the serum
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| C11-Choline PET/CT | Procedure or surgery | Hyperparathyroidism |
Primary outcome
Improved localization of a parathyroid adenoma
1 secondary outcome
Facilitation of detection of the parathyroid adenoma at surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperparathyroidism, run by Hadassah Medical Organization 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 1 inclusion and 0 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 15 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 Marina Orevi, MD (0508946211, marinaor@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved localization of a parathyroid adenoma. 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 15 Oct 2010.