Parathyroid AdenomaNCT01084356
Evaluation of a New CZT System
An observational study of Parathyroid Adenoma and Thyroid Adenoma, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The purpose of the study is to check if the new CZT system has an advantage in detection of small osseous processes, thyroid adenomas, parathyroid adenomas and detection of sentinel node, in comparison with the techniques in use. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parathyroid Adenoma, Thyroid Adenoma
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to Mar 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: consequtive patiants admitted for the above scans and consented to be further investigated by the CZT system
Who may be able to join
- age over 18
Who cannot join
- pregnancy
- patients unable to understand and sign an informed consent
- age under 18
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center
Tel Aviv
Einat Even Sapir, PhD, MD, 972-3-6974444 ext. 3536, evensap@tasmc.health.gov.il
Ayelet Kurzband, BA, 972-3-6974444 ext. 3536, ayeletk@tasmc.health.gov.il
About this study
Official title: Evaluation of a New CZT System for Imaging in Routine Nuclear Medicine Examination
The purpose of the study is to check if the new CZT system has an advantage in detection of small osseous processes, thyroid adenomas, parathyroid adenomas and detection of sentinel node, in comparison with the techniques in use.
Participants: 100 subjects male and female that come to the institute of nuclear medicine for routine screening examinations.
The CZT screening takes 10 minutes and does not require any extra intervention to the routine screening.
- Conditions
- Parathyroid Adenoma, Thyroid Adenoma
- Keywords
- CZT, sentinel node, osseous processes
- Medical subject headings
- Parathyroid Neoplasms, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hand | patients admitted for Tc MDP for evaluation of carpal/metacarpal and finger bone lesions | |
| thyroid | patients admitted for Tc thyroid scan | |
| parathyroid | patients investigated for parathyroid adenoma | |
| sentinel node | patients who are due to sentinel node biopsy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Einat Even Sapir, PhD, MD, Principal investigator, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084356
- Sponsor's protocol ID
- TASMC-10-EES-0649-CTIL
- Status last verified
- Mar 2010
- First submitted
- 9 Mar 2010
- Last updated
- 10 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Gambhir SS, Berman DS, Ziffer J, Nagler M, Sandler M, Patton J, Hutton B, Sharir T, Haim SB, Haim SB. A novel high-sensitivity rapid-acquisition single-photon cardiac imaging camera. J Nucl Med. 2009 Apr;50(4):635-43. doi: 10.2967/jnumed.108.060020.
PubMed 19339672Hruska CB, Phillips SW, Whaley DH, Rhodes DJ, O'Connor MK. Molecular breast imaging: use of a dual-head dedicated gamma camera to detect small breast tumors. AJR Am J Roentgenol. 2008 Dec;191(6):1805-15. doi: 10.2214/AJR.07.3693.
PubMed 19020253Mueller B, O'Connor MK, Blevis I, Rhodes DJ, Smith R, Collins DA, Phillips SW. Evaluation of a small cadmium zinc telluride detector for scintimammography. J Nucl Med. 2003 Apr;44(4):602-9.
PubMed 12679406Ketchum LE. New equipment in nuclear medicine, part 1: solid-state detectors. J Nucl Med. 1998 Nov;39(11):15N, 35N-36N. No abstract available.
PubMed 9829562Rhodes DJ, O'Connor MK, Phillips SW, Smith RL, Collins DA. Molecular breast imaging: a new technique using technetium Tc 99m scintimammography to detect small tumors of the breast. Mayo Clin Proc. 2005 Jan;80(1):24-30. doi: 10.1016/S0025-6196(11)62953-4.
PubMed 15667025O'Connor MK, Phillips SW, Hruska CB, Rhodes DJ, Collins DA. Molecular breast imaging: advantages and limitations of a scintimammographic technique in patients with small breast tumors. Breast J. 2007 Jan-Feb;13(1):3-11. doi: 10.1111/j.1524-4741.2006.00356.x.
PubMed 17214787Tsuchimochi M, Hayama K, Oda T, Togashi M, Sakahara H. Evaluation of the efficacy of a small CdTe gamma-camera for sentinel lymph node biopsy. J Nucl Med. 2008 Jun;49(6):956-62. doi: 10.2967/jnumed.108.050740. Epub 2008 May 15.
PubMed 18483107
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New CZT System for Imaging in Routine Nuclear Medicine Examination
- ClinicalTrials.gov ID
- NCT01084356
- Acronym / sponsor ID
- TASMC-10-EES-0649-CTIL
- Conditions
- Parathyroid Adenoma, Thyroid Adenoma
- Keywords
- CZT, sentinel node, osseous processes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (estimated)
- First posted
- 10 Mar 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 check if the new CZT system has an advantage in detection of small osseous processes, thyroid adenomas, parathyroid adenomas and detection of sentinel node, in comparison with the techniques in use.
Participants: 100 subjects male and female that come to the institute of nuclear medicine for routine screening examinations.
The CZT screening takes 10 minutes and does not require any extra intervention to the routine screening.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| hand | – | –patients admitted for Tc MDP for evaluation of carpal/metacarpal and finger bone lesions |
| thyroid | – | –patients admitted for Tc thyroid scan |
| parathyroid | – | –patients investigated for parathyroid adenoma |
| sentinel node | – | –patients who are due to sentinel node biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- consequtive patiants admitted for the above scans and consented to be further investigated by the CZT system
Key inclusion criteria (1 listed)
- age over 18
Key exclusion criteria (3 listed)
- pregnancy
- patients unable to understand and sign an informed consent
- age under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2010.
- Background: PubMed 19339672Gambhir SS, Berman DS, Ziffer J, Nagler M, Sandler M, Patton J, Hutton B, Sharir T, Haim SB, Haim SB. A novel high-sensitivity rapid-acquisition single-photon cardiac imaging camera. J Nucl Med. 2009 Apr;50(4):635-43. doi: 10.2967/jnumed.108.060020.
- Background: PubMed 19020253Hruska CB, Phillips SW, Whaley DH, Rhodes DJ, O'Connor MK. Molecular breast imaging: use of a dual-head dedicated gamma camera to detect small breast tumors. AJR Am J Roentgenol. 2008 Dec;191(6):1805-15. doi: 10.2214/AJR.07.3693.
- Background: PubMed 12679406Mueller B, O'Connor MK, Blevis I, Rhodes DJ, Smith R, Collins DA, Phillips SW. Evaluation of a small cadmium zinc telluride detector for scintimammography. J Nucl Med. 2003 Apr;44(4):602-9.
- Background: PubMed 9829562Ketchum LE. New equipment in nuclear medicine, part 1: solid-state detectors. J Nucl Med. 1998 Nov;39(11):15N, 35N-36N. No abstract available.
- Background: PubMed 15667025Rhodes DJ, O'Connor MK, Phillips SW, Smith RL, Collins DA. Molecular breast imaging: a new technique using technetium Tc 99m scintimammography to detect small tumors of the breast. Mayo Clin Proc. 2005 Jan;80(1):24-30. doi: 10.1016/S0025-6196(11)62953-4.
- Background: PubMed 17214787O'Connor MK, Phillips SW, Hruska CB, Rhodes DJ, Collins DA. Molecular breast imaging: advantages and limitations of a scintimammographic technique in patients with small breast tumors. Breast J. 2007 Jan-Feb;13(1):3-11. doi: 10.1111/j.1524-4741.2006.00356.x.
- Background: PubMed 18483107Tsuchimochi M, Hayama K, Oda T, Togashi M, Sakahara H. Evaluation of the efficacy of a small CdTe gamma-camera for sentinel lymph node biopsy. J Nucl Med. 2008 Jun;49(6):956-62. doi: 10.2967/jnumed.108.050740. Epub 2008 May 15.
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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.
Einat Even Sapir, PhD, MD principal investigator
Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
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 Parathyroid Adenoma and Thyroid Adenoma, run by Tel-Aviv Sourasky Medical Center 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 3 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 10 Mar 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 Einat Even Sapir, PhD,MD (972-3-6974444 ext. 3536, evensap@tasmc.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 NCT01084356, which also lists 7 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 10 Mar 2010.