Nodular GoiterNCT07258199
TACE Treats Nodular Goiter
A study testing TACE in people with Nodular Goiter, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
transarterial bleomycin chemoembolization represents a novel minimally invasive therapeutic approach for the management of giant nodular goiter. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nodular Goiter
- What is being tested?
- TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- abnormal coagulation profiles;
- hepatic or renal impairment;
- allergy to contrast media;
- refusal of interventional therapy and requirement for surgical treatment or other therapies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Nodular Goiter
- Being tested
- TACE
- Keywords
- Transarterial chemoembolization, Giant nodular goiter, Bleomycin, Drug-loaded microspheres
- Medical subject headings
- Goiter, Nodular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEProcedure or surgery
TACE, 15,000U bleomycin and 200-400μm drug-loaded microspheres
| Study group | Role | What they receive |
|---|---|---|
| TACE | Experimental | Not described Receives: Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume
Lesion volume measurement on contrast-enhanced CT
Measured: 1-, 3-, 6-, 12-month follow up
Secondary outcomes (2)
longest diameter
Measurement of the longest lesion diameter on contrast-enhanced CT
Measured: 1-, 3-, 6-, 12-month follow-up
lesion shrinkage
Measured: 1-, 3-, 6-, 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Sep 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nodular GoiterStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258199
- Sponsor's protocol ID
- TACE treats nodular goiter
- Status last verified
- Nov 2025
- First submitted
- 17 Sep 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transarterial Chemoembolization With Bleomycin: A Promising Treatment of Giant Nodular Goiter
- ClinicalTrials.gov ID
- NCT07258199
- Acronym / sponsor ID
- TACE treats nodular goiter
- Conditions
- Nodular Goiter
- Keywords
- Transarterial chemoembolization, Giant nodular goiter, Bleomycin, Drug-loaded microspheres
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
transarterial bleomycin chemoembolization represents a novel minimally invasive therapeutic approach for the management of giant nodular goiter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE | Experimental | Procedure: TACE |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- abnormal coagulation profiles;
- hepatic or renal impairment;
- allergy to contrast media;
- refusal of interventional therapy and requirement for surgical treatment or other therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TACETACE, 15,000U bleomycin and 200-400μm drug-loaded microspheres | Procedure or surgery | TACE |
Primary outcome
volume
Time frame: 1-, 3-, 6-, 12-month follow up
Lesion volume measurement on contrast-enhanced CT
2 secondary outcomes
longest diameter
Time frame: 1-, 3-, 6-, 12-month follow-up
lesion shrinkage
Time frame: 1-, 3-, 6-, 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TACE in people with Nodular Goiter, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume (time frame: 1-, 3-, 6-, 12-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.