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Mortality Benefit of Ultrasound for Thyroid Nodules Identified With PET Imaging: Non-Inferiority Emulated Target Trial

NCT ID: NCT07255482

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-15

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Thyroid Nodule (Benign) Thyroid Nodule (Diagnosis) Thyroid Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with thyroid nodule on PET

Thyroid Ultrasound

Intervention Type DIAGNOSTIC_TEST

Thyroid ultrasound performed within 3 months of PET to characterize a thyroid nodule identified on the PET

Interventions

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Thyroid Ultrasound

Thyroid ultrasound performed within 3 months of PET to characterize a thyroid nodule identified on the PET

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Age \>=18
2. Thyroid nodule on PET-CT performed 1/1/2015 to 12/31/2021
3. At least one clinical note in the EHR from the 36-month window prior to the PET

Exclusion Criteria

1. Thyroid ultrasound listed in the medical record in the prior 3 years
2. Documented history of prior thyroid cancer diagnosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harvard School of Public Health (HSPH)

OTHER

Sponsor Role collaborator

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey P Guenette

Associate Professor of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R18HS029839

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

2024P002073-1

Identifier Type: -

Identifier Source: org_study_id