TACE Treats Nodular Goiter

November 27, 2025 updated by: Peking Union Medical College Hospital

Transarterial Chemoembolization With Bleomycin: A Promising Treatment of Giant Nodular Goiter

transarterial bleomycin chemoembolization represents a novel minimally invasive therapeutic approach for the management of giant nodular goiter.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical criteria: thyroid enlargement, mostly painless, with compressive symptoms (such as dysphagia, dyspnea) being less common; thyroid function is mostly normal, and a small number may be accompanied by hyperthyroidism or hypothyroidism.
  • Imaging examinations: ultrasound shows multiple solid or cystic-solid nodules with clear boundaries and no malignant signs such as microcalcification and a vertical-to-horizontal diameter ratio >1.
  • Pathological criteria: follicular epithelial cell hyperplasia, no nuclear atypia, and no malignant cellular characteristics (such as mitotic figures, infiltrative growth, etc.). In this study, a thyroid goiter with at least one diameter exceeding 4 cm was considered a giant goiter

Exclusion Criteria:

  • abnormal coagulation profiles;
  • hepatic or renal impairment;
  • allergy to contrast media;
  • refusal of interventional therapy and requirement for surgical treatment or other therapies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TACE
Procedure: TACE
TACE, 15,000U bleomycin and 200-400μm drug-loaded microspheres

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
volume
Time Frame: 1-, 3-, 6-, 12-month follow up
Lesion volume measurement on contrast-enhanced CT
1-, 3-, 6-, 12-month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
longest diameter
Time Frame: 1-, 3-, 6-, 12-month follow-up
Measurement of the longest lesion diameter on contrast-enhanced CT
1-, 3-, 6-, 12-month follow-up
lesion shrinkage
Time Frame: 1-, 3-, 6-, 12-month follow-up
1-, 3-, 6-, 12-month follow-up

Other Outcome Measures

Outcome Measure
Time Frame
postoperative complications
Time Frame: 1-, 3-, 6-, 12-month follow-up
1-, 3-, 6-, 12-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

September 17, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TACE treats nodular goiter

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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