Neoplasm of BreastPhase 2/3NCT02860104
Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions
A Phase 2/3 study testing microwave ablation in people with Neoplasm of Breast, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The investigators will perform this study to prospectively analyse the clinical outcome after percutaneous microwave ablation(MWA) of benign and malignant breast lesion under ultrasound (US) guidance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasm of Breast
- What is being tested?
- microwave ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Dec 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- breast lesion proved by using core-needle biopsy;
- for benign lesions,lesion 1.0 cm or larger in greatest diameter and continually increasing during a half year follow-up; for malignant ones, lesion size 2cm or smaller;
- distance of at least 1.0cm to papilla with the patients supine;
- the symptoms of local pain, discomfortable or compression considered probably relating to the lesion of breast;
- the patient with evidently psychological pressure due to the occurrence of the lesion;
- patients unwilling or refused to receive other treatment and presence of an appropriate route for percutaneous puncture under US guidance.
Who cannot join
- patients who were pregnant or breast-feeding;
- patients with evidence of coagulopathy or acute or severe pulmonary insufficiency or heart dysfunction;
- patients during menstrual period;
- patients who wanted to undergo other therapies including surgical excision and vacuum-assisted biopsy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jie Yu, Doctor, 8610-66939530, yu-jie301@hotmail.com
About this study
Official title: Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions: A Prospective Multicenter Study
The investigators will perform this study to prospectively analyse the clinical outcome after percutaneous microwave ablation(MWA) of benign and malignant breast lesion under ultrasound (US) guidance.
Read the detailed description
A total of more than 500 patients diagnosed with benign breast lesions and 50 patients with malignant breast lesions in seven centers of China will be recruited in this study and underwent US-guided percutaneous MWA treatment. Information for each patient includes demographics; longest diameters of tumors; tumor numbers; tumor pathological type; location of tumor according to whether adjacent to skin, pectoralis, areola and papilla. Ablation variables including session, puncture, time, and power; complete ablation, complications; reduction in volume, palpability, pain and cosmetic satisfying outcomes,recurrence,survival will be measured and analyzed.
- Conditions
- Neoplasm of Breast
- Being tested
- microwave ablation
- Keywords
- microwave ablation, breast, multicenter
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microwave ablationDevice
ultrasound guided percutaneous microwave ablation for breast lesions
| Study group | Role | What they receive |
|---|---|---|
| microwave ablation | Other | microwave ablation Receives: Device: microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in volume
the volume reduction ratio (VRR) which was calculated by the following equation: VRR (%) = [(initial volume - final volume) × 100]/initial volume.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startDec 2012
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neoplasm of BreastStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
- Investigators
- Ping Liang, Doctor, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860104
- Sponsor's protocol ID
- 939530lp
- Status last verified
- Nov 2016
- First submitted
- 2 Aug 2016
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: cosmetics effect, volume reduction rate,complications
Publications
Yang Q, Li H, Chen BH, He GZ, Wu XP, Wang LX, Wu H, Dou JP, Han ZY, Zhang J, Yu XL, Yu J, Liang P. Ultrasound-guided percutaneous microwave ablation for 755 benign breast lesions: a prospective multicenter study. Eur Radiol. 2020 Sep;30(9):5029-5038. doi: 10.1007/s00330-020-06868-9. Epub 2020 Apr 30.
PubMed 32356159Yu J, Wu H, Meng XW, Mu MJ, Dou JP, Ahmed M, Liang P. Ultrasound-guided percutaneous microwave ablation of central intraductal papilloma: a prospective pilot study. Int J Hyperthermia. 2019;36(1):606-612. doi: 10.1080/02656736.2019.1619849.
PubMed 31179781
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions: A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT02860104
- Acronym / sponsor ID
- 939530lp
- Conditions
- Neoplasm of Breast
- Keywords
- microwave ablation, breast, multicenter
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Aug 2016 (estimated)
- 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.
The investigators will perform this study to prospectively analyse the clinical outcome after percutaneous microwave ablation(MWA) of benign and malignant breast lesion under ultrasound (US) guidance.
Detailed description
A total of more than 500 patients diagnosed with benign breast lesions and 50 patients with malignant breast lesions in seven centers of China will be recruited in this study and underwent US-guided percutaneous MWA treatment. Information for each patient includes demographics; longest diameters of tumors; tumor numbers; tumor pathological type; location of tumor according to whether adjacent to skin, pectoralis, areola and papilla. Ablation variables including session, puncture, time, and power; complete ablation, complications; reduction in volume, palpability, pain and cosmetic satisfying outcomes,recurrence,survival will be measured and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| microwave ablation | Other | Device: microwave ablationmicrowave ablation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- breast lesion proved by using core-needle biopsy;
- for benign lesions,lesion 1.0 cm or larger in greatest diameter and continually increasing during a half year follow-up; for malignant ones, lesion size 2cm or smaller;
- distance of at least 1.0cm to papilla with the patients supine;
- the symptoms of local pain, discomfortable or compression considered probably relating to the lesion of breast;
- the patient with evidently psychological pressure due to the occurrence of the lesion;
Key exclusion criteria (4 listed)
- patients who were pregnant or breast-feeding;
- patients with evidence of coagulopathy or acute or severe pulmonary insufficiency or heart dysfunction;
- patients during menstrual period;
- patients who wanted to undergo other therapies including surgical excision and vacuum-assisted biopsy.
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 |
|---|---|---|
| microwave ablationultrasound guided percutaneous microwave ablation for breast lesions | Device | microwave ablation |
Primary outcome
reduction in volume
Time frame: 5 year
the volume reduction ratio (VRR) which was calculated by the following equation: VRR (%) = [(initial volume - final volume) × 100]/initial volume.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- Derived from this study: PubMed 32356159Yang Q, Li H, Chen BH, He GZ, Wu XP, Wang LX, Wu H, Dou JP, Han ZY, Zhang J, Yu XL, Yu J, Liang P. Ultrasound-guided percutaneous microwave ablation for 755 benign breast lesions: a prospective multicenter study. Eur Radiol. 2020 Sep;30(9):5029-5038. doi: 10.1007/s00330-020-06868-9. Epub 2020 Apr 30.
- Derived from this study: PubMed 31179781Yu J, Wu H, Meng XW, Mu MJ, Dou JP, Ahmed M, Liang P. Ultrasound-guided percutaneous microwave ablation of central intraductal papilloma: a prospective pilot study. Int J Hyperthermia. 2019;36(1):606-612. doi: 10.1080/02656736.2019.1619849.
- Individual participant dataSharing planned: Yes. cosmetics effect, volume reduction rate,complications
Related trials for Neoplasm of Breast
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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. This study is not recruiting at the moment.
Ping Liang, Doctor study chair
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing microwave ablation in people with Neoplasm of Breast, run by Chinese PLA General 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 6 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: status not confirmed, as of the sponsor's last update on 23 Nov 2016. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Yu, Doctor (8610-66939530, yu-jie301@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in volume (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02860104, which also lists 2 linked publications.
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 23 Nov 2016.