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OpenTrials
Enrolling by Invitation

NCT Number: NCT07258199

TACE Treats Nodular Goiter

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

Enrolling by Invitation

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Key information

Conditions

Nodular Goiter Endocrine System Diseases Goiter Goiter, Nodular Thyroid Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TACE

Procedure

TACE, 15,000U bleomycin and 200-400μm drug-loaded microspheres

Primary outcomes

  1. volume

    Time frame: 1-, 3-, 6-, 12-month follow up

    Lesion volume measurement on contrast-enhanced CT

Secondary outcomes

  1. longest diameter

    Time frame: 1-, 3-, 6-, 12-month follow-up

    Measurement of the longest lesion diameter on contrast-enhanced CT

  2. lesion shrinkage

    Time frame: 1-, 3-, 6-, 12-month follow-up

Other outcomes

  1. postoperative complications

    Time frame: 1-, 3-, 6-, 12-month follow-up

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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