Thyroid Nodule (Benign)NCT07255482
Mortality Benefit of Ultrasound for Thyroid Nodules Identified With PET Imaging: Non-Inferiority Emulated Target Trial
An observational study of Thyroid Nodule (Benign) and Thyroid Nodule (Diagnosis), run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The investigators hypothesize that all-cause mortality in patients with an incidental thyroid nodule on PET-CT who did not have thyroid ultrasound (the exposure) within 3 months of the PET-CT is non-inferior within a 5% margin to those who have thyroid ultrasound at 7-years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule (Benign), Thyroid Nodule (Diagnosis), Thyroid Cancer
- What is being tested?
- Thyroid Ultrasound
- How many people
- 874 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2025to 4 Aug 2026
- 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 who had a PET-CT at Mass General Brigham 1/1/2015 to 12/31/2021
Who may be able to join
- Age >=18
- Thyroid nodule on PET-CT performed 1/1/2015 to 12/31/2021
- At least one clinical note in the EHR from the 36-month window prior to the PET
Who cannot join
- Thyroid ultrasound listed in the medical record in the prior 3 years
- Documented history of prior thyroid cancer diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Mortality Benefit of Ultrasound for Incidental Thyroid Nodules Identified With PET Imaging: A Non-Inferiority Emulated Target Trial
The investigators hypothesize that all-cause mortality in patients with an incidental thyroid nodule on PET-CT who did not have thyroid ultrasound (the exposure) within 3 months of the PET-CT is non-inferior within a 5% margin to those who have thyroid ultrasound at 7-years. That is, among patients with an incidental thyroid nodule on PET-CT, mortality is no more than 5% larger (in absolute difference) for those who do not have thyroid ultrasound compared to those who do. The investigators will also report mortality differences at landmark timeframes of 1-year, 3-years, 5-years, and 10-years. To estimate group differences in mortality, the investigators will conduct a non-inferiority emulated target trial utilizing clone-censor weighting to address potential immortal time bias introduced by the 3-month grace period. The investigators will adjust for demographic, potential confounder, and mortality risk adjustor factors. The investigators will stratify analyses based on baseline disease severity (estimated 5-year relative survival risk) and disease status (progression, lymph node involvement, other sites of metastases). All subjects will be accrued from the Mass General Brigham healthcare system, which includes two academic medical centers, a specialty head and neck hospital, and multiple community hospitals and numerous community clinics.
Read the detailed description
Study Hypothesis: The investigators hypothesize that all-cause mortality in patients with an incidental thyroid nodule on PET-CT who did not have thyroid ultrasound within 3 months is no worse than 5% lower than those who did have ultrasound.
Outcome Measures:
Primary Outcome: All-cause mortality. Secondary Outcomes: Numbers of thyroid cancer diagnoses, thyroid ultrasounds, thyroid biopsies, and thyroid surgeries Exploratory Outcomes: Types of thyroid cancer diagnoses
Study Population: All patients age 18-years and older with incidental thyroid nodule on PET-CT performed between 1/1/2015 and 12/31/2021.
Sites/Facilities: Mass General Brigham healthcare system including Massachusetts General Hospital, Brigham and Women's Hospital, Mass Eye and Ear, and associated community sites.
Exposure: Thyroid ultrasound evaluation within 3-months of PET-CT.
- Being tested
- Thyroid Ultrasound
- Medical subject headings
- Thyroid Nodule, Disease, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid UltrasoundDiagnostic test
Thyroid ultrasound performed within 3 months of PET to characterize a thyroid nodule identified on the PET
| Study group | Role | What they receive |
|---|---|---|
| Patients with thyroid nodule on PET | Not described Receives: Diagnostic Test: Thyroid Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality
Measured: 7 Years
Secondary outcomes (4)
Number of Thyroid Cancer Diagnoses
Measured: 7 Years
Number of Thyroid Ultrasound Examinations
Measured: 7 Years
Number of Thyroid Biopsies
Measured: 7 Years
Number of Thyroid Surgeries
Measured: 7 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start15 Oct 2025
- Primary completion30 Nov 2025
- Study completion4 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Nodule (Benign)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Retrospective
- Enrolment
- 874 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Jeffrey P Guenette, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255482
- Sponsor's protocol ID
- 2024P002073-1
- Other IDs
- R18HS029839
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All deidentified data used in the study analysis.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality Benefit of Ultrasound for Incidental Thyroid Nodules Identified With PET Imaging: A Non-Inferiority Emulated Target Trial
- ClinicalTrials.gov ID
- NCT07255482
- Acronym / sponsor ID
- 2024P002073-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 874 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 4 Aug 2026 (actual)
- First posted
- 1 Dec 2025 (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.
The investigators hypothesize that all-cause mortality in patients with an incidental thyroid nodule on PET-CT who did not have thyroid ultrasound (the exposure) within 3 months of the PET-CT is non-inferior within a 5% margin to those who have thyroid ultrasound at 7-years. That is, among patients with an incidental thyroid nodule on PET-CT, mortality is no more than 5% larger (in absolute difference) for those who do not have thyroid ultrasound compared to those who do. The investigators will also report mortality differences at landmark timeframes of 1-year, 3-years, 5-years, and 10-years. To estimate group differences in mortality, the investigators will conduct a non-inferiority emulated target trial utilizing clone-censor weighting to address potential immortal time bias introduced by the 3-month grace period. The investigators will adjust for demographic, potential confounder, and mortality risk adjustor factors. The investigators will stratify analyses based on baseline disease severity (estimated 5-year relative survival risk) and disease status (progression, lymph node involvement, other sites of metastases). All subjects will be accrued from the Mass General Brigham healthcare system, which includes two academic medical centers, a specialty head and neck hospital, and multiple community hospitals and numerous community clinics.
Detailed description
Study Hypothesis: The investigators hypothesize that all-cause mortality in patients with an incidental thyroid nodule on PET-CT who did not have thyroid ultrasound within 3 months is no worse than 5% lower than those who did have ultrasound.
Outcome Measures:
Primary Outcome: All-cause mortality. Secondary Outcomes: Numbers of thyroid cancer diagnoses, thyroid ultrasounds, thyroid biopsies, and thyroid surgeries Exploratory Outcomes: Types of thyroid cancer diagnoses
Study Population: All patients age 18-years and older with incidental thyroid nodule on PET-CT performed between 1/1/2015 and 12/31/2021.
Sites/Facilities: Mass General Brigham healthcare system including Massachusetts General Hospital, Brigham and Women's Hospital, Mass Eye and Ear, and associated community sites.
Exposure: Thyroid ultrasound evaluation within 3-months of PET-CT.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with thyroid nodule on PET | – | Diagnostic Test: Thyroid Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had a PET-CT at Mass General Brigham 1/1/2015 to 12/31/2021
Key inclusion criteria (3 listed)
- Age >=18
- Thyroid nodule on PET-CT performed 1/1/2015 to 12/31/2021
- At least one clinical note in the EHR from the 36-month window prior to the PET
Key exclusion criteria (2 listed)
- Thyroid ultrasound listed in the medical record in the prior 3 years
- Documented history of prior thyroid cancer diagnosis
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 |
|---|---|---|
| Thyroid UltrasoundThyroid ultrasound performed within 3 months of PET to characterize a thyroid nodule identified on the PET | Diagnostic test | Patients with thyroid nodule on PET |
Primary outcome
All-Cause Mortality
Time frame: 7 Years
4 secondary outcomes
Number of Thyroid Cancer Diagnoses
Time frame: 7 Years
Number of Thyroid Ultrasound Examinations
Time frame: 7 Years
Number of Thyroid Biopsies
Time frame: 7 Years
Number of Thyroid Surgeries
Time frame: 7 Years
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 10 Aug 2026.
- Individual participant dataSharing planned: Yes. All deidentified data used in the study analysis.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nodule (Benign) and Thyroid Nodule (Diagnosis), run by Brigham and Women's Hospital at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 10 Aug 2026. 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 United States. 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?
All-Cause Mortality (time frame: 7 Years). 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 10 Aug 2026.