NCT07258199

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
16mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Sep 2025Sep 2027

Study Start

First participant enrolled

September 1, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

September 17, 2025

Last Update Submit

November 27, 2025

Conditions

Nodular Goiter

Keywords

Transarterial chemoembolizationGiant nodular goiterBleomycinDrug-loaded microspheres

Outcome Measures

Primary Outcomes (1)

  • volume

    Lesion volume measurement on contrast-enhanced CT

    1-, 3-, 6-, 12-month follow up

Secondary Outcomes (2)

  • longest diameter

    1-, 3-, 6-, 12-month follow-up

  • lesion shrinkage

    1-, 3-, 6-, 12-month follow-up

Other Outcomes (1)

  • postoperative complications

    1-, 3-, 6-, 12-month follow-up

Study Arms (1)

TACE

EXPERIMENTAL
Procedure: TACE

Interventions

TACEPROCEDURE

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

TACE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Goiter, Nodular

Condition Hierarchy (Ancestors)

GoiterThyroid DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2025

First Posted

December 2, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Locations

CN(1)