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Enrolling by invitationNCT07258199Updated Dec 2, 2025

TACE Treats Nodular Goiter

An interventional study of TACE in Nodular Goiter, sponsored by Peking Union Medical College Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Nodular Goiter

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Keywords

  • Transarterial chemoembolization
  • Giant nodular goiter
  • Bleomycin
  • Drug-loaded microspheres
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    TACE

    Procedure: TACE

Interventions

  • ProcedureTACE

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

05

What researchers measure

Primary outcomes

  1. volume

    Lesion volume measurement on contrast-enhanced CT

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

Secondary outcomes

  1. longest diameter

    Measurement of the longest lesion diameter on contrast-enhanced CT

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

  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

06

Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, China
07

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07258199
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Dec 2, 2025
Start date
Sep 1, 2025
Primary completion
Sep 1, 2026 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Dec 2, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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