Thyroid NeoplasmsSNTCNCT01089335
Sentinel Lymphnode in Patients With Papillary Thyroid Carcinoma and in Patients With Suspected Thyroid Neoplasia
An observational study of Thyroid Neoplasms and Thyroid Cancer, run by Region Skane at 1 site in Sweden.
Trial summary
The standard surgical treatment for highly differentiated papillary thyroid cancer > 10 mm according to recent national and international guidelines, is total thyroidectomy and central lymphnode clearance, and for patients with cytology indicating thyroid neoplasia of unclear malignant potential hemithyroidectomy on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Neoplasms, Thyroid Cancer
- What is being tested?
- Histological investigation of the SN
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2010to Dec 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: - Patients diagnosed and operated for papillary thyroid cancer > 10 mm at the Department of Surgery, Skåne University Hospital, Lund, Sweden _ Patients with diagnosed and operated for a thyroid tumour of unclear malignant potential at the Department of Surgery, Skåne University Hospital, Lund, Sweden
Who may be able to join
- Patients with first time surgery for proven papillary thyroid cancer > 10 mm
- Patients with first time surgery for a cytologic diagnosis of follicular neoplasia or suspected (not proven) malignancy
Who cannot join
- Age below 18 years
- Pregnancy or lactation
- Inability to understand written and oral information or to comply with scheduled follow-up
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Surgery and Department of Imaging, Skåne University Hospital
Lund, 221 85
About this study
Official title: Sentinel Node Investigation in Patients With Highly Differentiated Papillary Thyroid Carcinoma and in Patients With Thyroid Neoplasia of Unclear Malignant Potential
The standard surgical treatment for highly differentiated papillary thyroid cancer > 10 mm according to recent national and international guidelines, is total thyroidectomy and central lymphnode clearance, and for patients with cytology indicating thyroid neoplasia of unclear malignant potential hemithyroidectomy on the side of the tumour.
The study investigates if the sentinel lymphnode (SN)
- Reliably (with high sensitivity and specificity), can predict the pathological findings of the lymphnodes in the central compartment in patients with highly differentiated papillary thyroid cancer
- Is useful to aid in the final diagnosis and staging of thyroid neoplasias of unclear malignant potential, and could be used to select patients for further central lymphnode revision.
Read the detailed description
The standard surgical treatment for highly differentiated papillary thyroid cancer > 10 mm according to recent national and international guidelines, is total thyroidectomy and central lymphnode clearance, and for patients with cytology indicating thyroid neoplasia of unclear malignant potential hemithyroidectomy on the side of the tumour.
There are however a number of clinical problems with these approaches:
- For patients with papillary thyroid cancer, a significant proportion will receive unnecessary extensive surgical treatment
- In papillary thyroid cancer, central lymphnode clearance increases the risk for complications, especially the risk for hypoparathyroidism.
According to a Scandinavian survey (Scandinavian Quality Register for Thyroid- and Parathyroid Surgery; www. thyroid-parathyroidsurgery.com),16 % of patients with unclear follicular neoplasia, will have a final histological diagnosis of thyroid cancer, and in half of them, this cancer will be of the papillary subtype. In patients with preoperatively suspected, but not proven malignancy by cytology, 30 % will receive a final histological diagnosis of thyroid cancer, and in these patients, 70 % will be of the papillary subtype. Typically these patients will undergo a second operation with a contralateral hemithyroidectomy. In many cases, due to risk for complications, central lymphnode clearance is avoided in these cases. Therefore, the staging of the cancer will be incomplete, and some patients will receive suboptimal surgical treatment.
The study is designed to compare SN investigation with the final histology of the central lymphnodes:
- Pretracheal and bilateral paratracheal for patients with preoperatively diagnosed papillary thyroid cancer
- Pretracheal and ipsilateral paratracheal for tumours of uncertain malignant potential on cytology
The identification of SN will be aided by preoperative ultrasound guided injection of 99m- Tc- nanocolloid albumin in the thyroid tumour. The results of the histological investigation of SN will be compared to that of the results from the central lymphnode clearance.
- Conditions
- Thyroid Neoplasms, Thyroid Cancer
- Being tested
- Histological investigation of the SN
- Keywords
- Sentinel node, Thyroid cancer, Thyroid neoplasia, Follicular neoplasia
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histological investigation of the SNProcedure or surgery
99m Tc- nanocolloid albumin, 10-15 MBq (volume 0.1-0.3 ml) is injected under ultrasound guidance in the thyroid tumour. Imaging (lymphoscintigraphy)with anterior and oblique projections is performed at 60 and 120 min after the injection. SN are mapped intraoperatively by a dedicated SN navigator and excised for final histology.
| Study group | Role | What they receive |
|---|---|---|
| Papillary thyroid cancer | Patients with preoperatively diagnosed highly differentiated papillary thyroid cancer Receives: Procedure: Histological investigation of the SN | |
| Tumour of uncertain malignant potential | Thyroid tumours with preoperative cytology indicating follicular neoplasia, or on cytology suspected but not proven malignancy Receives: Procedure: Histological investigation of the SN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of SN histology compared with the final histology of the non SN central lymph nodes (metastasis or no metastasis)
The histological investigation of the sentinel lymph node(s) (recorded as metastasis or no metastasis), will be compared to the definitive histological investigation of the non SN central lymphnodes (metastasis or no metastasis), cleared by surgery. Sensitivity and specificity of the histological SN investigation to predict the histological outcome of the non SN central lymphnodes (metastasis or no metastasis), will be calculated.
Measured: 14 days
Secondary outcomes (1)
Sensitivity of 99mTc-nanocolloid albumin in the diagnosis of a sentinel lymphnode
99mTc-nanocolloid albumin will be injected under guidence by ultrasonography. The sensitivity to detect a SN on preoperative imaging (detected SN on imaging/total number of investigations) and during surgery by a collimated probe for SN mapping(SN detected/total number of operations), will be calculated.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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 (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders Bergenfelz, MD, PhD, Principal investigator, Department of Surgery, Skåne University Hospital, Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089335
- Sponsor's protocol ID
- 2009/71
- Acronym
- SNTC
- Status last verified
- Mar 2019
- First submitted
- 16 Mar 2010
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Node Investigation in Patients With Highly Differentiated Papillary Thyroid Carcinoma and in Patients With Thyroid Neoplasia of Unclear Malignant Potential
- ClinicalTrials.gov ID
- NCT01089335
- Acronym / sponsor ID
- SNTC / 2009/71
- Conditions
- Thyroid Neoplasms, Thyroid Cancer
- Keywords
- Sentinel node, Thyroid cancer, Thyroid neoplasia, Follicular neoplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 18 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 standard surgical treatment for highly differentiated papillary thyroid cancer > 10 mm according to recent national and international guidelines, is total thyroidectomy and central lymphnode clearance, and for patients with cytology indicating thyroid neoplasia of unclear malignant potential hemithyroidectomy on the side of the tumour.
The study investigates if the sentinel lymphnode (SN)
- Reliably (with high sensitivity and specificity), can predict the pathological findings of the lymphnodes in the central compartment in patients with highly differentiated papillary thyroid cancer
- Is useful to aid in the final diagnosis and staging of thyroid neoplasias of unclear malignant potential, and could be used to select patients for further central lymphnode revision.
Detailed description
The standard surgical treatment for highly differentiated papillary thyroid cancer > 10 mm according to recent national and international guidelines, is total thyroidectomy and central lymphnode clearance, and for patients with cytology indicating thyroid neoplasia of unclear malignant potential hemithyroidectomy on the side of the tumour.
There are however a number of clinical problems with these approaches:
- For patients with papillary thyroid cancer, a significant proportion will receive unnecessary extensive surgical treatment
- In papillary thyroid cancer, central lymphnode clearance increases the risk for complications, especially the risk for hypoparathyroidism.
According to a Scandinavian survey (Scandinavian Quality Register for Thyroid- and Parathyroid Surgery; www. thyroid-parathyroidsurgery.com),16 % of patients with unclear follicular neoplasia, will have a final histological diagnosis of thyroid cancer, and in half of them, this cancer will be of the papillary subtype. In patients with preoperatively suspected, but not proven malignancy by cytology, 30 % will receive a final histological diagnosis of thyroid cancer, and in these patients, 70 % will be of the papillary subtype. Typically these patients will undergo a second operation with a contralateral hemithyroidectomy. In many cases, due to risk for complications, central lymphnode clearance is avoided in these cases. Therefore, the staging of the cancer will be incomplete, and some patients will receive suboptimal surgical treatment.
The study is designed to compare SN investigation with the final histology of the central lymphnodes:
- Pretracheal and bilateral paratracheal for patients with preoperatively diagnosed papillary thyroid cancer
- Pretracheal and ipsilateral paratracheal for tumours of uncertain malignant potential on cytology
The identification of SN will be aided by preoperative ultrasound guided injection of 99m- Tc- nanocolloid albumin in the thyroid tumour. The results of the histological investigation of SN will be compared to that of the results from the central lymphnode clearance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Papillary thyroid cancer | – | Procedure: Histological investigation of the SNPatients with preoperatively diagnosed highly differentiated papillary thyroid cancer |
| Tumour of uncertain malignant potential | – | Procedure: Histological investigation of the SNThyroid tumours with preoperative cytology indicating follicular neoplasia, or on cytology suspected but not proven malignancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Patients diagnosed and operated for papillary thyroid cancer > 10 mm at the Department of Surgery, Skåne University Hospital, Lund, Sweden _ Patients with diagnosed and operated for a thyroid tumour of unclear malignant potential at the Department of Surgery, Skåne University Hospital, Lund, Sweden
Key inclusion criteria (2 listed)
- Patients with first time surgery for proven papillary thyroid cancer > 10 mm
- Patients with first time surgery for a cytologic diagnosis of follicular neoplasia or suspected (not proven) malignancy
Key exclusion criteria (3 listed)
- Age below 18 years
- Pregnancy or lactation
- Inability to understand written and oral information or to comply with scheduled follow-up
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 |
|---|---|---|
| Histological investigation of the SN99m Tc- nanocolloid albumin, 10-15 MBq (volume 0.1-0.3 ml) is injected under ultrasound guidance in the thyroid tumour. Imaging (lymphoscintigraphy)with anterior and oblique projections is performed at 60 and 120 min after the injection. SN are mapped intraoperatively by a dedicated SN navigator and excised for final histology. | Procedure or surgery | Papillary thyroid cancer, Tumour of uncertain malignant potential |
Primary outcome
Sensitivity and specificity of SN histology compared with the final histology of the non SN central lymph nodes (metastasis or no metastasis)
Time frame: 14 days
The histological investigation of the sentinel lymph node(s) (recorded as metastasis or no metastasis), will be compared to the definitive histological investigation of the non SN central lymphnodes (metastasis or no metastasis), cleared by surgery. Sensitivity and specificity of the histological SN investigation to predict the histological outcome of the non SN central lymphnodes (metastasis or no metastasis), will be calculated.
1 secondary outcome
Sensitivity of 99mTc-nanocolloid albumin in the diagnosis of a sentinel lymphnode
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
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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.
Anders Bergenfelz, MD, PhD principal investigator
Department of Surgery, Skåne University Hospital, Lund
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 Thyroid Neoplasms and Thyroid Cancer, run by Region Skane at 1 site in Sweden.
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 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: finished, as of the sponsor's last update on 28 Mar 2019. 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 Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity and specificity of SN histology compared with the final histology of the non SN central lymph nodes (metastasis or no metastasis) (time frame: 14 days). 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 28 Mar 2019.